Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process

Background Proximal humerus fracture (PHF) complications, whether following surgery or nonoperative management, require standardization of definitions and documentation for consistent reporting. We aimed to define an international consensus core event set (CES) of clinically-relevant unfavorable events of PHF to be documented in clinical routine practice and research. Methods A Delphi exercise was implemented with an international panel of experienced shoulder trauma surgeons selected by survey invitation of AO Trauma members. An organized list of PHF events after nonoperative or operative management was developed and reviewed by panel members using on-line surveys. The proposed core set was revised regarding event groups along with definitions, specifications and timing of occurrence. Consensus was reached with at least a two-third agreement. Results The PHF consensus panel was composed of 231 clinicians worldwide who responded to at least one of two completed surveys. There was 93% final agreement about three intraoperative local event groups (device, osteochondral, soft tissue). Postoperative or nonoperative event terms and definitions organized into eight groups (device, osteochondral, shoulder instability, fracture-related infection, peripheral neurological, vascular, superficial soft tissue, deep soft tissue) were approved with 96 to 98% agreement. The time period for documentation ranged from 30 days to 24 months after PHF treatment depending on the event group and specification. The resulting consensus was presented on a paper-based PHF CES documentation form. Conclusions International consensus was achieved on a core set of local unfavorable events of PHF to foster standardization of complication reporting in clinical research and register documentation. Trial registration Not applicable. Supplementary Information The online version contains supplementary material available at 10.1186/s12891-021-04887-1.


Device events
Definition : Events affecting any component of the implanted device or material, or the instrumentation used for their implantation. Specifications : -Instrument problem (breakage, failure) -lmplant (breakage, malpositioning, separation) -Screw / bolt joint perforation -Cementation problems

Osteochondral events
Definition : Events affecting the osteochondral tissue of the proximal humerus, clavicula and/or scapula Specifications : Fracture (including hairline fracture), articular cartilage damage Soft tissue events Definition : Events involving only the soft tissue at the treated shoulder Specifications : -Skin, muscle, tendon, joint capsule, Iigament, Iabrum -Blood vessels (bleeding) : bleeding at the surgical site that requires additional intervention or Ieads to a stop of the operation -Nerves*: recognized damage of a neurological structure which needs additional surgical intervention *a standard Iist of potentially affected nerves will only be presented for postoperative neurological events 97% (206/213) agreed about these definitions and specifications of intra-operative events Comments and suggestions from participants who disagreed "Blood vessels should be termed arterial injury." "Nerve injury may not be immediately recognized and may not need additional surgery" "Neurological damage is unclear. A temporary palsy because of manipulation without full recovery but not suitable for surgical intervention is not a local event? Why surgical intervention is the criteria for including neurological damage when we should not define the complication according to it treatment? Maybe any neural damage should be included. In a similar way bleeding should be modified." "-Instrument or implant problems should be specified whether due to material or handling problem or surgical error -joint perforation in my opinion is not an implant problem but a surgical error" "Environmental events pertaining to theater environment may include but not be limited to: 1. Anaesthesia related complications. 2. Ancillary equipment failure like table, diathermy, C arm, laminar flow, power breakdown etc. " "I'm not sure, if the term screw/bolt joint perforation in device events is in any time an event. Some surgeons drill through the articular surface to get the best stability of the screw and make it as long as possible. Anyway, this Drilling causes an articular cartilage damage (osteochondral event) but could be absolutely normal. Even if you use some k-wires to stabilize the fracture you can make an cartilage damage. Soft tissue is ok." "recognized damage of a neurological structure should be the event… whether or not it needs additional surgical intervention " Comments and suggestions from participants who agreed "Drug/anaesthetic events: -nerve injury following regional blockade -antibiotic reaction/anaphylaxis" "Screw or bolt articular perforation should be included in the osteochondral events in my opinion. " "Soft tissue events -nerves -If the definition includes 'which needs additional surgical intervention then its relying on a treatment decision by the surgeon. Shouldn't the definition of the event be independent of the treatment?" "Intraoperative events arising as a result of patient positioning as shoulder tables are not routinely available in our setups e.g. Brachial plexus traction injury as a result of excessive tilt of the cervical spine" "Breakage of an implant very unlikely intraoperative. Instrumentation? Seldom possible. 'Hairline fracture' ?" "specification device problem: choosing the wrong implant (non-original, bad qualit ect.)" "does this include infection?" "Maybe to add missing of adequate material !" "can we add malreduction of fractures & re-displacement during fixation as intraoperative unfavorable events." Postoperative / non-operative local events ( 1 ) We propose to structure local events according to the following event groups: 1-lmplant (device) events: Events affecting any implanted device (e.g. nail, plate, prosthesis) which are shown on adequate postoperative imaging (e.g. radiographs, ultrasound, CT) or affecting any external device (e.g. sling, orthesis) used to immobilize the fracture, which is associated with clinical symptoms 2-Osteochondral events: Events affecting the osteochondral tissue of the proximal humerus, clavicula and/or scapula 3-Shoulder instability: Symptomatic shoulder associated with loss of alignment of the articulating surfaces 4-Peripheral neurological events: Events resulting from peripheral neurological injury at the fracture site, which are associated with sensory and/or motor and/or autonomic disturbance 5-Vascular events: Events involving laceration, avulsion, contusion, puncture or crush injury to an artery, vein or micro vascularity at the fracture site 6-lnfections: Surgical Site lnfections (SSI) with definition and specifications adapted from the 2008 Centers for Disease Control and Prevention (CDC) definition AND, in shoulder arthroplasty, late hematogenous infections with periprosthetic infections defined according to international consensus 7-Superficial soft tissue events: Events affecting the superficial soft tissues (i.e. skin and subcutaneous tissue) at and around the fracture site/wound that do not affect deep soft tissues (i.e. fascia, muscle, articular capsule) and that require additional treatment 8-Deep soft tissue events: Events affecting the deep soft tissues (i.e. fascia, muscle, articular capsule), except infections

Notes
None of the considered events in the core set must be present or occur prior to or at the time of trauma. Hence they are to be distinguished from concomitant lesions directly resulting from the trauma.
Some of these event groups may not apply to specific treatment modalities. This will be determined in the following sections of this survey.
Participants' agreement with these event groupings (n,%) Definitely not -Rather not 3 (2%) Undecided 4 (2%) Rather yes 75 (38%) Yes, definitely 115 (58%) Comments and suggestions "Rates of venous thromboembolic events particularly pulmonary emboli, to guide the discussion on need and type of any thromboprophylaxis" "Nerve injuries should be included in one of the groups" "-Periarticular calcification where does it belong? -Head necrosis" "Not sure about microvasculature damage defined as 'vascular' event, rather should be part of 'soft tissue' events" "'Patient related events' e.g. multimorbidity, alcohol abuse, osteoporosis, obesity, neurological problems" "Because the Saphenous vein and its branches were exposed in the operative field and easily got injured, is this a vascular event? How to define the microvascularity at the fracture site?" "But the rotator cuff needs to be emphasized as an entity" "Would be very difficult to decide about the 'depth' of the infection." "Where are Malreductions and Non unions? What about shoulder Stiffness? is that under 8?" "I think that the grouping is very good" "Minor vein or micro vascular events irrelevant " "I do not know whether you should include external devices under implants" "I will probably include FRI criteria (Injury 2018) in infection." "Still in doubt about the definition. intraop complication is something that occurred during intervention even is recognised on the postop xrays (an intrarticular screw not seen intraop )" "we Need a clear diagnosistic or a least a description of the Trauma of the shoulder during surgery" "I like this!!!!" "Implant Events that depend on clinical symptoms are difficult. A Perforation of the head without complaints. is this a complication or not?" "If we were to change shoulder instability to joint instability, then we may be able to apply this to other joints as well." "May need to add ultrasound to assess rotator cuff and biceps" "Waaaaay too complex. While theoretically sound, of no use in daily practice" "ROM should be include the event groups." "2 exclude clavicula" "In deep soft tissue events consider stiffness as an example." "In surgical treatment, some may be intraoperative events, it is difficult to identify when the event occurred: -Osteochondral events -Shoulder instability -Peripheral neurological events -Vascular events" "I am not sure about osteochondral events , probably most of them can be classified as implant related " "I would add events related to the rotator cuff and biceps tendon" "None " "I think there are maybe to many" "Preexisting rotator cuff tears discovered during the surgical intervention should be included as a separate group since it is not unusual to encounter this pathology during fixation" "Some are very rare (instability, vascular, neurological) consider the use of periop. regional anaesthesia (may have biasing nerve affection)" * Suggested periods were specified as: "Until union has been achieved"; "Until healing or failure"; "Postop, 6 weeks, 3 months, 6 months, 12 months"; "Until healing"; "6 weeks"; "18 months" and "Dependent on type of implant and progress of consolidation" (one response was missing).

Comments and suggestions
"Immediate post op. xrays and after 3 weeks" "In case of no union more" "In case of fractures, if fracture heals, one year is enough" "If any of such implants failure happens, it will happen within 3 months in my experience. But sometimes it may happen after 6 months if these patients perform overloading before consolidation of fracture site." "Definition of pseudarthrosis" "May need another time to confirm HW is ok at say 6 months also." "Regarding 'malpositioning' the term of 'expected position' seems rather subjective. I suggest to change into 'suggested' or 'required'." "Events should be divided as early and late. Early would be for example, proud positioning of the implant and late implant breakage." "Screw cut out or penetration of articular surface" "I believe that the control should be at 3, 6 months until the year, since in many cases the events in relation to the implant develop late." "What is screw or 'bold' backout?" "Implant removal which may or may not happen. Albeit most likely the effective timeline of implant complications is probably at whatever point nonunion is declared" "I suggest 5 postoperative follow ups in order to also determine between intra-/perioperative implant events and long term related implant events" "From Post Op, till fracture healing." "Implant related events are not limited to the time but to the presence of this material in my opinion" "Assuming you mean screw or 'bolt' backout?" "Malpositioning should be limited to intra-op, postop displacement is a separate event implant bending What about fracture fragment migration relative to the implant At what level ? humeral head or humeral diaphysis " "We can expected complications until the fracture is healed. Afterwards, the majority of the complications are related to implant removal, that should be addressed separately." "Three months is suitable since after that there is gradual increase in the lost to follow up rate and hence it may not depict the actual incidence of complications and their relevance. Otherwise 12 months follow up seems more comprehensive." "12 months without radiological changes" "Until bony consolidation or implant removal" "I think 12 months is enough to see any implant event!!!" "Again, the discussion will be about 'with clinical symptoms'. Personally I agree, if no clinical symptoms than no complication. However, this is a Major discussion point." "Intra-and immediate postoperative imaging should be separated from follow-up controls as to better differentiate surgical work from secondary effects (such as non-healing, implant related etc) timeline: at least!" "6 weeks 3 , 6 months, 12 months optional " "Reasoning should be given space for proper evaluation and also for measures taken for the events" "3 month and 12 month" "Actually, the work of implant is only till the bone unites, but it can attract few unfavorable events till it is insitu." "Over a twelve month period with multiple follow up" "As far as the fracture is evolving to healing , in fractures at the extremities of long bones you have a stable mechanical condition at 3 months. otherwise if have a delayed union or epiphyseal necrosis you will need a longer image follow up" "If fracture subsidence occurs and articular perforation then occurs is it the device or healing process??" "The issue is that the events occur at different timelines malposition -immediate radiolucency -6-12 months screw blackout -3-6 months implant breakage -12-18 months implant migration -variable" "Consider secondary screw penetration (mixed osteochondral event and implant event) in ORIF" "Screw perforations sometimes take place following the avascular necrosis of the humeral head. How should we describe them as complications? 1. avascular necrosis only 2. screw perforations and avascular necrosis,; separately described. 3. screw perforations after avascular necrosis; consecutively described." "Prostheses need shorter follow-up than osteosynthetic implants as no need to monitor osteoregeneration as diligently. Likewise, osteoporotic fractures will need longer f/u than young patients. Elective implant removal has very poor scientific basis, so should be omitted as a timeframe" "We can add also screw non locking in the plate of LCP , It can happen in the uni directional locking head screws if missed the correct direction specially in the osteoporotic bone" "6 months or till healing of the fracture" "'Implant Migration' is misleading. Implant rarely migrates, the bone fails around the unchanged implant. I would change the wording." "3 and 12 months" "Perhaps you should add the pull-out failure mechanism of the plate/screws as specification. " "While six months is likely more than enough time for most patients, it should capture the vast majority of complications." "Please add screw penetration into the joint" "In vast majority of cases, implant related issues are evident within the first 6-8 weeks." "Also include implant usage with improper principles" "Late subsidence and screw penetration can occur especially in valgus impacted and malreduced fractures or when soft tissues are compromised during the surgical intervention" "In some instances implant position may not change but bone segment may escape (e.g. greater tuberosity). This should be specified. " "Intraoperative malpositioning and postoperative implant displacement are 2 separate things and both should be included independently" "Malposition: good Screw cut out: must be considered (is one of the most common complications of locking plates which is the most commonly used implant for These fractures) Screw backout: rare (maybe for nails) Loosening: rare maybe only used for arthroplasty but then >12mt fup Implant breakage: good Implant Migration: rare (rather consider cut out of screws)" "At 2 weeks post op as well" Non-operative local events (3) Breakage, loosening "breakage loosening compression" "breakage" "Breakage of the splint" "Displacement of immobilization device" "Damaged bandage" "device breakage" Malposition / malfit "malposition unstable malfit impinging thumb or elbow strangulation" "Bad position of orthesis which can cause dislocation." "Incorrect positioning, soft-tissue damage" "Malpositioning of the sling / splint" "Strangulation of the arm" "material chaffing discomfort when wearing awkward adjustment" "most important would be position of the arm and if there were soft tissue issues or neurapraxias or discomfort" "Ease of wearing device Level of comfort Functional independence in performance of activities of daily living with brace on" Stiffness "Stiffness of elbow, external rotation stiffness" "Elbow stiffness Hand stiffness " "stiffness elbow" "Decrease in the ROM " "neighbouring joints (elbow) rigidity" "Stiffness" "neck stiffness and elbow stiffness needing physiotherapy" "Joint stiffness" "Stiffness of shoulder and other joints." "Joint stiffness" Peripheral neurological symptoms "radial nerve palsy due pressure at lower end of humerus" "peripheral neurological symptoms due to nerve compression (e.g. ulnar nerve)" "excessive pressure to the tissue with neurological consequences" "Sympathetic Nervous changes like CRPS." "peripheral neurological events" "Nerves and edema compressions by orthesis" "nerve injuries" "Neurovascular events" "neurapraxias" "Ulnar nerve injury from sling use" "ulnar nerve symptoms from sling" Skin lesions "Patient comfort with the device, skin irritation from the Orthosis etc. " "Skin reaction" "Sweating Maceration Skin lesions" "Skin irritation" "skin irritation" "Skin irritation Decubitus" "Skin ulcerations ?" "Superficial soft tissue events" "Skin lesions" "Skin problems caused by the device" "Bruises and other soft tissue complications caused by sling or orthesis" "Skin Problems cervical spin problems" "Skin irritation" "skin irritations and lesions caused by device or member positioning" "lacerations" "Skin breakdown/rashes requiring ongoing care" "Skin ulcer due to the sling compression" "skin breakage" "Skin breakdown" "Skin problem" "skin breakdown. skin fungal infection, skin bacterial infection" "skin complications" "skin problems" "skin breakdown" "skin blisters" "skin complication: contact dermatitis" "Skin lesions due to mechanical compression by the orthosis" "Skin breakdown" Allergy "Allergy" "Allergic reaction to device" Pressure sores "Pressure sores " "Pressure ulcers. Uncomfortableness" "Pressing and strangling of soft tissue structures by orthesis and sling." "Pressure sore" "Skin sore ulcers" "Sores" "Pressure sores" "Pressure ulcers" "Pressure sore" "Pressure events" "Cast sores" "skin complication: pressure sore" Pain "Pain" "Neck pain" "Neck pain" "Devices site pain (distinguished from fracture pain)" "neck complaints" "pain and level of daily activities" "Slings May affect cervical symptoms" "neck pain from sling" Compartment Syndrome "Deep Vein Thrombosis, Compartment Syndrome," Deep Vein Thrombosis "Deep Vein Thrombosis, Compartment Syndrome," "Vascular events" "Vascular events like low venous comeback" Edema upper extremity "edema upper extremity" "upper limb oedema" "Hand is swollen because the sling is low" "edema" "edema compressions by orthesis" Device type "Sling, standard or abduction" "Shoulder immobilizer." "Sling" (3) "Shoulder abduction brace or simple immobiliser or cuff collar sling" "1. cast or slab 2. arm sling 3. duration of immobilisation 4. whether pendulum exercise allowed within the immobiliser." "devices limiting ROM or function only" "Uses of Orthosis or long arm cast along with sling" "sling and cast and brace " "any orthosis or sling" "plaster cast, orthosis" "Method of Device and duration and time or removal and exercise." "sling, desault bandage, in rare cases cast" "Sling Cast" "arm sling" "Shoulder support sling and /or arm sling" "just the type of sling used and if this was use in Add, Abd or IR" "anything which is used for non-operative treatment." "Sling" "Type an time of immobilization, start of pendulum etc" "also include external fixator" "What device is used? Time when device used. Can we undress device when we do X-ray, sleep, take bath" "Sling and Collar and cuff" "There are many devices Some are much different than others" "Shoulder immobiliser" "Cast & Brace" "simple sling versus fixed sling" "kind of sling abduction pillow? internal rotation of the forearm in Gilchrist? " "Cuff Collar Sling Ultra sling Aeroplane splint Pouch arm sling" "1. shoulder immobiliser 2. aeroplane splint 3. shoulder starpping" "Sling immobilization" "Shoulder sling with or without backstrap" "sling collar and cuff arm-to-chest" "sling gilchrist" "type of the cast or sling" "Shoulder arm immobilizer" "Shoulder immobilizer and X-ray at 15 days post treatment " Other comments / issues "duration, type" "Length of time of immobilization Was PT used to help recover motion and function Passive ROM started when Active assist ROM started when Active ROM started when" "casts, slings, splints, bandages" "how long the patient used the sling" "Time to mobilization, time to full active movement allowed" "Time instructed to wear a sling." "Duration for U slab immobilisation ." "allowed ROM active/passive time of immobilization" "Self-directed discontinuation of use." "removal by patient" "discontinuing usage change from external device to operative treatment " "If it is considered important (I am not sure how often it would be) compliance" "Compliance of use, duration, position (abduction, degrees), rehabilitation protocol, active vs passive motion, time until abduction> 90°, load bearing, return to work, return to sport. " "Compliance" "impossibility to use, non-compliance" "Non compliance by patient" "Compliance" "Non-compliance for the device " "patients compliance to wear the device" "Non-Compliance with instructions" "Compliance of wearing; comfort" "Patient compliance to the treatment" "Difficult to assess the compliance of slings" "Discontinuity in using the device" "Patient compliance" "unused immobilization device" "Orthosis usage time. Time to do without orthosis" "Problems to adjust the orthosis, thus resulting in non-usage of it" "Compliance, appropriate use, adequateness of the device chosen / bought by the patient" "Patient compliance Treatment failure -device not used Change of device" "Difficulty with use" "Undisplaced fracture" "Increasing displacement of the Fx" "secondary fracture dislocation" "Change in reduction" "Radiological change in position of fracture fragments in non operative management" "alteration of fracture position" "Lost of reduction" "Delayed/non union" "initial fracture displacement at time of injury, secondary displacement of the fracture, delayed union, non-union, mal-union, posttraumatic humeral head necrosis, posttraumatic omarthrosis" "And event that determinerà non Union or deteriorino of Clinical situation" "But probably irrelevant" "Immobilization by Mayo clinic of 3 weeks" "Complications local related to device" "any" "If a fracture is well reduced and the implant is stable, do not use external restraints If I decide non operative management 4 weeks would be the time and then it is sent to therapy" "Device events may have long-term effects, for example on ROM or local integument, so observation period should be longer" "any of them" "Prolonged immobility" Postoperative local events: Osteochondral events

Proposed definitions
Bone formation / resorption "Painful movements, inability to abduct, myositis in case of head injury, instability due to inadequate fixation and mobilization " "The removal of bone by osteoclasts. Bone formation, ossification, process by which new bone is produced" "Any loss of bone , or new bone formation" "Bone resorption: signal of radiological radiolucency near the fracture site Bone formation: Radiological sign of calcium deposition and loosening the area of initial fracture" "hypo or hyperdense new bone tissue after fr. fixation or healing" "Radiographic appearance of calcified image or radiographic disappearance of density in bone area compared with previous radiographs" "Change in bone quantity from prior radiographs" "Bone resorption as AVN. Bone formation as exuberant callus or heterotrophic ossification although very rare around shoulder joint." "xray finding" "Change in size of fragment" "Lucency around screw" "comparison between immediate post-op x-ray and follow up exams" "Progressive fragmentation of the head due to osteonecrosis Bone resorption around the screws may indicate loosening and impending failure Resorption of tuberosity bone due to osteolysis" "As compared to baseline standard radiological views and serial progressive x-rays at definite time intervals, see for amount of new bone formed or the residual bone absorbed should be specified" "callus score" "Bone resorption will be appearance of radio lucency area while bone formation will be callus formation " "Resorption is a well-defined lucency around or at the fracture site due to activation of osteoclast bone formation is the ossification or osteogensis process at or around the fracture site due to new bone formation due to activation of osteoblast" which osteoclasts break down the tissue in bones and release the minerals, resulting in a transfer of calcium from bone tissue to the blood. doi:10.1126/science.289.5484.1504" "Loss of bone density around the fracture or implant" "Loss/gain of bone compared with immediate post-op images" "Stress shielding, remodeling of bone in unloaded zones, Spur formation" "Resorption of bone definition of healing callus formation of at least three cortices" "Comparison of repeated orthogonal X-ray images" "Bone formation as any bone like image occurring out of the fracture site. bone resorption as lack of bone or increased bone gap at the fracture site. Diminishing the amount of bone on the epiphysis or tuberosities" "Probably not" "Loose of visible bone on x ray / new bone detectable on x ray" "Subsidence callous formation" "When part of the humerus that was present disappears in follow up, same when abnormal bone formation occurs (similar to HO)" "Bone resorption would include osteolysis around implants or in the setting of a nonunion" "Osteopenia or obvious bone formation" "Changes in fx line in xray controls" "bone resorption sorry, unknown bone formation heterotopic ossification in the soft tissues and the joint." "..." "X-p" "Looseness of bone around the metal periosteal bone reaction and formation " "Presence of new bone on at least three side of bone on two views" "Radiolucency/radio-opacity" "Hypertrophic callus or subchondral bone resorption" "The amount of bone loss at the fracture site / The amount of callus formed around the fracture site" "New bone formation : callus" "This is a little confusing, but maybe 'abundant callus formation' or 'heterotopic bone formation'" "Visible new bone in the area of fracture" "Callus Formation in the fracture area Gap Formation at the fracture area" "CCD AHD gothic arc " "Radiolucency around screws or plates and fracture site. Presence of callus on sequential follow up Xrays in AP and Axillary or scapular views. " "Change in amount of bone around implant" "Bone formation -bridging callus around the metaphysic that was not present before fracture healing. Bone resorption -appearance of lucency on radiograph at the fracture site" "Bone resorption is loss of bone around screws/bolts as a sign of instability of the fracture Fixation bone formation is paraarticular ossification (prosthetic replacement) " "Apparition of the callus or sign of AVN" "Bone resorption -loss of bone tissue within the confines of bone perimeter. Bone formation -Appearance of new bone tissue on the outside of host bone perimeter." "Callous formation in AP/Lat views" "Absence or appearance of bone material, visible on x-rays " "Radiographic evidence of change on 2 successive radiographs" "Resorption: increasing radiolucency on follow-up X-rays Bone formation: new appearance of calcified shadows with trabecular structure on follow-up X-rays which are not secondary displaced fragments " "Formation of bone in areas not associated with the fracture. bone resorption " "Change in radiological appearance Heterotrophic ossification " "Bridging callus" "Implant loosening, callous bridging" "Loss in x ray" "Formation of extra bone of resorption of bone ends / tuberosities" "Lucency with or without sclerotic margins / callus or " "reduced bone density visible on x-ray" "Callous formation Screw Halos" "On x ray resorption of humeral head" "Lucency of >2mm at the fracture site or bone implant interface. " "Visibility of fx line on X-ray healing after 12 mt (yes/no)" "Resorption of the greater tuberosity" "Any resorption at the fracture site or of the tuberosity" "Resorption-radiolucency in and around implant -screw/ plate Formation: callus formation/ increased bone density, loss of visualization of fracture lines, continuity of bone on either side of fracture site"

New fracture (around the implant)
"A break in bone or cartilage, confirmed on x ray. New radiolucent line around implant" "Any fracture complete or incomplete around any type of implant" "Signal of osteolysis around the implant" "New fr. line after ORIF or CRIF on x ray" "Fractures of the humerus below the implant or through the implant" "New fracture on XR" "Stress shielding at the plate end." "xray finding" "New radiolucency line that connects to the implant" "Has to be classified as displaced or undisplaced" "Comparison between immediate post-op x-ray and follow up exams" "Fracture within 5 cm distal to the tip of the implant. Beyond this, the existing implant may not have a big bearing on how the peri-implant fracture is treated. " "As compared to baseline standard radiological views and serial progressive x rays at definite time intervals see for any fracture around the implant " "Any new fractures that were not evident in the pre-operative radiograph." "New fracture occur at the tip or around the implant intra-operative or post-operative" "Self-explaining. specification with classifications for perimplant and periprosthetic fractures of the proximal humerus (e.g. Vancouver classification)" "New fractures / fracture lines around the implant, which were not present before the operation" "Any loss of cortical continuity around the implant or within 2 bone widths/diameter of the tip of the implant" "New fracture line around the border of the implant" "Peri-implant fracture from a new injury or iatrogenic" "Anything visible on an xray. " "Fractures at screw or plate interface, or nail entry or tip" "New fracture line in same radiological view that was previously not present " "Fracture line on x ray" "Any new disruption of cortical integrity" "New fracture line not observed on " "Break in cortical bone. NO reference" "And New Line of radio-transparency" "X-ray confirmed fracture line in the area of implant location with clinical manifestations (pain, loss or reduction of segment function)." "Imposibilita to get. Bone contact , and. No restitution of the calcar " "Would seem somewhat self-evident, but fracture line about implant" "Fracture at the junction plate and diaphysis" "Definition should require new trauma, peri-implant fracture line, new fracture line in comparison to initial fracture" "New fracture lines not seen in the pre-op films" "Fracture line seen around the implant on x-ray or CT scan on the humerus, glenoid and acromion." "New fracture line around implant" "New fracture communicating with the implant." "Appearance of new fracture lines around the implant on X-ray" "Location topography of the fracture relation with screws/implant " "Any implanted side humeral fracture " "Duncan CP, Haddad FS (2014)  "Occurrence of a new fracture at the limit of osteosynthesis" "Fracture line in direct relation to the implant fracture in the same segment whose treatment should take into account the implant in situ" "New fracture lines after implant fixation" "Hidden fractures non diagnosed preoperatively and they displace while fixing the fracture Periprosthetic fractures: while reaming or implanting the definitive stem. Multifragmentary fracture of greater tuberosity which is missing to fix and displaces postoperatively. Fractures while drilling, specially wide screws in nails. Fractures while reaming for a nail Fractures while inserting a nail" "Opening of fissure lines, periprosthetic fractures, separating the shaft during nailing" "A post-operative new fracture around the implant at any time." "Jede Fraktur im Bereich des Implantates und unterhalb davon (Vancouver)" "A new fracture of the proximal humerus next to the plate or screws without new trauma." "Any fracture line near an hardware." "Any change to post-operative X-ray no matter the size or location." "Radiolucent lines with or without displacement of the bone in relation to the device, or starting from any the level of the device." "Development of new radiolucent line" "Classification according to Worland https://doi.org/10.1016/S1058-2746(99)90095-2" "Loss of continuity in most of cases due to a traumatic injury that causes that lesion near the implant" "Previously un-observed fracture" "Always possible" "Radiographic visible fracture, conventional or CT" "New fracture mostly distal from implant" "Repeated orthogonal X-rays " "Any fracture line , not present at the at the initial presentation, that is seen on subsequent X-rays at proximal or distal the implant site. Any fracture detected during operative fracture which was not the original one and attributed to handling for reduction or implant positioning" "Only if articular injury involved" "Breakage of bone continuity" "Radiographs" "Any fracture (broken bone) around an implant" "Fracture occurring at a site distinct from the original injury" "Obvious" "New fracture line in x-ray controls" "The fracture lines extending from the implant and its tips." "x" "Fracture of humerus next to implant" "X-p" "Fracture within the range of 1-5 cm proximal and distal to the fixation device " "New fracture at the side of screw holes or at the end of implant without efficient trauma" "Appearance of a fracture line on X-ray " "Name says it all" "It is the discontinuity of bone at or below the level of the implant" "We get cases fractures just below the plate due to fall on that operated limb" "Stress fracture" "'Peri-implant fracture'" "Fracture line in different area than original fracture, not more than 2 cm from the implant" "Postoperative new fracture line on conventional X-ray" "Descriptive" "New fracture line in the bed of/ proximal or distal to the implant on Xrays which was not present earlier ." "Any periprosthetic fracture distal to plate" "New fracture lines that did not exist prior to surgery" "Mostly fracture distal or adjacent to the end of an intramedullary device" "Implant near fractures-a fracture below the end of a plate" "Apparition of a new line of fracture " "Appearance of new discontinuity in bone around the area of fracture/surgery with use of implantable device." "Radiographically apparent fracture (CT or plain films)" "Fracture involving the bone around the implant, to be a postop event, a new trauma after the surgery is necessary" "Evidence of fracture within the same bone not present at time of insertion" "Any new fracture line" "New fracture about implant that was not there immediately post operatively" "Those that cannot be fixed with a separate implant " "Stress riser fractures" "Any detected (in doubt CT)" "x ray" "Periimplant fractures through or just below the implant" "Sharp, acute discontinuity of bone, in a position not fixed by the implant" "Any new fracture around the implant" "Another fracture line or an intraoperative fracture with implant implantation" "Tuberosity fracture or periprosthetic fracture as a stress fracture at the end of the plate especially in a rigid locking construct" "Any loss of continuity of the implanted devices or its parts" "Any new fracture" "Any new fractures occurring after surgery around the implants" "Occurrence of fracture line which was not seen in preoperative X-rays / which was not there intra operatively"

Screw / bolt cutout
"Loss of reduction -varus reduction, comminution at proximal end" "Increased prominence of screw or bolt on x ray" "Screw or bolt out 4 mm of the plate or nail or bone , as minimum" "x ray visible prominence of screw across hared circumference" "Radiographic image of penetration of the screw through the humeral head inside the joint" "Hardware extrusion compared with immediate postop imaging " "Bone resorption in screw tip in humoral head or implant failure causing bolt cut out." "Xray finding. John Gorzaga JOT paper" "Protrusion of screw/bolt tip through distal bone cortex/surface" "Based on X-ray appearance" "Comparison between immediate post-op x-ray and follow up exams" "Secondary penetration into the joint or outside the bone on orthogonal views. There should be no primary screw/ bolt violation of the joint/ humeral head on initial post-surgery X-rays " "As compared to baseline standard radiological views and serial progressive x rays at definite time intervals, see for loss of initial position of screw or bolt. see for cut out of screw or bolt" "Any migration of more than 5mm" "Migration of the screw within or outside the bone most common complication after plating fixation " "Secondary screw perforations should be excluded by CT scan. Alternatively a defined series of imaging may exclude primary screw perforation" "Screws / bolts protruding the cortex on the tip side" "Movement of an implant / screw / bolt >1 width/diameter of the screw/bolt or >3mm of the implant from its original position on exactly comparable images" "Change of the position of the screw / bolt on the control X-rays compare to the immediate intraoperative X-rays control" "Screws placed too deep and through the articular surface, or late penetration from fragment settling or from AVN. " "Anything visible on an xray that alters the treatment or outcome. likely to be all events" "Migration of screw or bolt from original intended position " "Changed position of screw or bolt in identical view" "Displacement of the implant and lucent line around it " "Movement of implant from where it was placed" "Perforation of screw\bolt into articular surface with progression from post OP xrays" "Change in position of screws with reference to articular surface. No reference" "Protrusion from cortical-articular surface " "X-ray confirmed migration of the screw with bone dilution in the area of its initial installation" "Breakage or protrusion into the joint " "Migration that is visible on plain films. from relative position on lateral cortex" "Displacement between hardware and bone " "Screw cut out is a penetration of the screw tip through the subcortical bone. However, reliable detection requires CT or specialized x-ray projection. Injury. 2014 Oct;45 (10):1557-63. doi: 10.1016/j.injury.2014.05.025. How many radiographs are needed to detect angular stable head screw cut outs of the proximal humerus -a cadaver study. Spross et al" "Screw changing position post op, and outside the bone border" "Screw/bolt position out of the bone as seen on any of the x-ray projection or CT scan image due to implant migration or bone resorption" "Catastrophic change in position of the device leading to failure of head fixation Would also add backout" "Tip of the screw/bolt not sitting entirely within the bone" "Penetration of the screw/bolt beyond the anatomical confines of intended bony region that it was placed in. Eg, articular penetration of PHILOS screws" "Bone displaces relative to the angle-stable screws which remain fixed to the plate +/-penetration of the joint " "Prominence of implant " "Any intra-articular screw penetration." "Any migration of screw with penetrating articular surface" "Any penetration in the articular surface," "Any change in the position of screw / bolt in three successive xrays AP and Y views projected identically six weeks apart" "Mobilization of an osteosynthetic screw from its initial location during the assembly" "Migration of the screw within the bone cutting the articular surface" "Displacement of bone/implant causing presence of screws out of the bone" "The head rotates while the screws remain locked, thus cutting the head joint surface. It is basically a loss of reduction the construction cannot support." "Penetration through the head" "Penetrating the cortex of the articular side of the humeral head at any time" "Radiologisch darstellbarer Überstand einer Schraubenspitze in Relation zur Humerusgelenkfläche (corticaler Rand) welcher nicht schon intraoperativ bestand" "Screw backing out change in position of screw penetration of the articular surface of bone with the screw tip" "Perforation of the humeral head (cortex) by one or more screws with complaints of crepitation with subsequent revision or perforation without complaint but with revision because of a surgeons decision." "Movement in mm on comparable X-ray projections Cave: differentiate vs. cut-through ! (possible) joint perforation yes/ no" "Change of position respect the healthy bone in secondary Xray" "Any change to post-operative X-ray no matter the size or location. " "In relation to the glenohumeral joint: 1) Primary cutout caused by screws / bolt to long penetrating the surface of the cartilage of the head 2) Secondary cutout either by 'sinking' of the head fragment (in the direction of the screws) OR the event that displacement of the head take place and there is a real 'cutout' (ie. penetrating the surface of the head cartilage) due to head displacement." "Changes of place of screw as compared to old xray" "Perforation of screw tip through head Fragment doi: 10.1007/s00264-017-3652-6" "Intra-articular penetration of the screws" "Loss of position with the original fragment" "Distinguish articular of sub-acromial from benign." "esp in locking plates" "Joint Perforation in one xray" "Perforation of the head" "As above" "Epiphysial perforation at its periphery" "yes" "Migration of implant through into the joint" "Radiographs" "When the screw / bolt protrudes into the humeral head" "Change in position of a screw/bolt from intraoperative/first postoperative xray to most recent xray" "Obvious" "Screw or bolt displacement in xray controls" "The penetration of the tips of the screws out of the joint surface." "x" "Doh" "X-p" "A screw pulling or cutting with it a circumferential bone " "Change in position of the screw relative to the bone with loss of reduction" "Mostly screw penetration during head displacement in locking plate fixation" "The migration of the screw or bolt through the bone" "In old age, osteoporotic bones, in diabetic patients we get screw or bolt cut out cases" "Osteoporotic Fractures" "Displacement of the bone and/or screw/bolt in which inherent stability provided by initial implant placement is lost." "Visible perforation of the screw/bolt through the head cartilage" "Difference in position between intra/postop x-ray and further follow up x-ray" "Descriptive" "Screw penetration on sequential X-rays" "Joint penetration by any of screw or bolt" "Backward migration of locking bolts of an imn" "Clinical and radiological diagnosed penetration of screw/bolt/wire through the humeral head in the joint space" "Loosening of screws" "Violation of humerus head perimeter by implant device in any one radiological view." "Penetration of screw into glenohumeral joint of outside of humeral head" "Screw mobilization" "Radiolucency/breakage or change in position in consecutive xrays" "Penetration of the tip of screw / bolt through subchondral bone layer" "Migration of screw or bolt from immediate post op XRs" "Aftermath of implant loosening" "Any visible" "x ray" "Cutout of screw into humeral head radiographic images" "Protrusion beyond the chondral surface in any x-ray plane" "Any screw / bolt penetrating the articular surface" "Xray evidence of same" "Screw penetration into the joint due to varus collapse" "Penetration of the hardware through intact bone adjacent to the implant with loss of alignment" "Head screw cut out in any radiographic projection" "Any change in screw position" "Any screw cut out that occurs after surgery" "Migration of screw from its initial post op position -mostly breaching cortex or articular surface"

Tuberosity migration / resorption
"Unreduced tuberosity, poor fixation of tuberosity" "Radiological signs, increased radiolucency or migration of tuberosity" "The humeral head height ( "Radiographic image of disappearance of the greater tuberosity or change of position of the greater tuberosity with respect to previous radiographs" "Change in position compared with immediate postop imaging" "Malreduction of tuberosities or bony resorption will lead to failed construct and rotator cuff insufficiency." "X-ray finding but may need CT scan" "Displacement of tuberosity of more than 2 mm -Reduction in size of tuberosity including previous measurement as separation from other fragments" "Displacement more than 5 mm and compared to immediate post op. for conservative it is change in position from initial X-rays" "Comparison between immediate post-op x-ray and follow up exams" "Any change in tuberosity / tuberosity fragments position compared to initial post surgery X-rays. Fragmentation/ osteolysis of tuberosity fragments define tuberosity resorption" "Migration more than 5 mm in any direction" "Baseline comparison with standard radiological views and serial progressive x rays at definite time interval, any change in size and position of the bony structures like tuberosities " "1. Migration -any displacement of greater tuberosity altering the head to tuberosity distance as evident by change in dimensions from the immediate post-operative radiograph. 2. lucency of greater tuberosity, thereby reducing the profile of it to be considered for resorption." "Displacement more than 5 mm " "Analysis of tuberosity Position and quality in comparison to contralateral side " "Between the initial postoperative and the follow-up x-ray, there is clear migration of the tuberosity, at least 0.5cm Resorption: if the fragment get's smaller" "Movement / resorption >2mm from original position on exactly comparable images" "Change of the position of the tuberosities or the change of the size of tuberosity on the control X-rays compare to the immediate intraoperative X-ray control" "Loss of tuberosity reduction changes from initial postop imaging" "Anything altering the relationship of the cuff to the head. Resorption that does not result in loss of cuff function is physiological rather than pathological" "Rise or detachment of the greater tuberosity" "Tuberosity migration = redisplacement or tuberosity from original intended position after internal fixation or initial xray for nonoperative treatment. Tuberosity resorptive = lysis of bone in tuberosity compared to initial xray" "Distracted tuberosity position in identical view that was not present previously " "Relation between the head of the humerus and the acromion " "Movement from where it was or loss of bone density" "x-ray showing any displacement in tuberosity. repeated x-ray until the time of revision or end of follow-up with progressive resorption" "Change in position of tuberosity. NO reference" "Comparable variation of position of tuberosity" "Radiographically confirmed migration of tuberosity more than 3mm /decrease in bone density of tuberosity by 1.5-2 times from the bone" "Elevation of the greater tuberosity, loss of range of motion. " "Migration is movement of more than 2mm from post op position. " "Displacement on consecutive X rays osteopenia of the tuberosities" "Is defined as displacement of the tuberosity of more than 5mm in comparison to postop radiographs (again CT scan or defined x-ray). Tuberosity resorption can be defined as radiological disappearance of the tuberosity or a combination of clinical signs of rotator cuff insufficiency in combination with radiological resorption. I could not find reliable literature so far on a definition in this case." "Further displacement of the tuberosities on CT, more than 5mm" "Change in tuberosity position and bone quality detected on x-ray or CT scan." "Tuberosities change position from intraoperative radiographs postoperatively resorption--tuberosities disappear; unable to see the bony anatomy" "Where tuberosity was confirmed in a satisfactory position on intraoperative or early postoperative imaging but has subsequently migrated or resorbed." "Progressive Posterior and/or Superior shift of tuberosity identified in serial follow up X-rays." "Sequential X-ray mm in relationship to the humeral head " "Dislocation of tuberosity more than 3-5mm or extinction of tuberosity on x-ray," "More than 5 mm displacement / complete resorption of the tuberosity" "Any change in position of the tuberosity more than 5 mm from the post operative position after either ORIF or Arthroplasty Factors associated with failure of tuberosity osteosynthesis need to be mentioned 1. Poor initial position of the prosthesis (specifically, excessive height and/or retroversion) 2. Poor position of the greater tuberosity 3. Women over age 75 years (likely with osteopenic bone). Tuberosity malposition and migration: "Jede Stellungsänderung der Tuberkula im Vergleich zum intraoperativen Befund / Zunehmende Transparenz der Tuberkula bis zum völligen Verschwinden im konventionellen Rö" "Displacement of more than 1 cm compared to intra-operative images" "Secondary displacement of more than 2 mm of the greater or lesser tuberosity compared to operative Images." "Migration: 3-D-movement description resorption: loss of normal bone structure" "Loss of bone stock; changes of the position respect post-op Xray check" "Any change to post-operative X-ray no matter the size or location. " "1) Migration: Position of tubercles has changed from their initial position on a plain radiograph during FU.
2) Resorption: Radiolucency of the tubercles during FU at 3 months or later" "Changes in subsequent Xray" "Redislocation or absence of tuberosities after ORIF or prosthetic replacement in proximal humerus fractures" "Loss of bone density and loss of reduction and secondary malalignment of tuberostiy" "Change in tuberosity position from immediate post-op films loss of bone mass" "After reduction and fixation in fracture hemiprosthesis or after plating (not so rare)" "Regular position, under head line, above head line in AP view" "Vanishing of tuberosity or loss of reduction" "As above " "Displacement of tuberosity from its anatomic position. It is migration if it were appropriately reduced primarily and mal reduced if it is displaced just after the osteosynthesis. resorption if it was present in the immediate post op X ray and no more at follow up" "if affects joint surface" "dislocation / dissolution ?" "radiographs" "When tuberosity displaces more than 5 mm or disappear in the follow up" "Migration: Displacement of the tuberosity from original reduction/anatomic position resorption: Gradual bone loss of tuberosity after initial stable healing" "Movement or osteopenia" "Displacement / 'vanishing' tuberosity in xray controls" "greater tubercle disappearance during the follow-up" ">5mm" "X-p" "g .tuberosity partial or total detachment and displacement with loss of bone mass" "A proximal shift of the a tuberosity of more than 2cm" "Displacement of tuberosities in the follow-up" "The distance migrated by the tuberosities following a fracture" "In comminuted tuberosity cases we get migration of tuberosity." "Displacement of tuberosity" "Displacement of the greater tuberosity from its injury/postop position; or resorption of the bone." "Tuberosity migration -sequential change of position of tuberosity with respect to the head resorption -no presence of the bone in the area of greater or lesser tuberosity visible on x-ray, CT or MRI" "Difference in Position between intra/postop x-ray and further follow up x-ray" "Descriptive or measurement by CT" "Proximal, anterior or posterior migration on sequential Xrays" "Tuberosity migration compared to previous xray" "Malposition of the tuberosity -GT -superior to the humeral head." "Secondary displacement/resorption of the greater or lesser tuberosity on x-rays during follow-up period (comparison between time at surgery and 6 weeks/3 months)" "Secondary displacement of the tuberosity or apparition of AVN " "Change in position of tuberosity with immediate post-operative image as benchmark." "Displacement of greater than 2mm" "Mobilization of a tuberosity that usually follows the tension of the muscles resorption of a tuberosity probably following necrosis" "Change in position/loss of greater tuberosity bone of the greater tuberosity over two radiographs" "Migration: secondary displacement of tuberosity fragment Resorption: increasing radiolucency or complete disappearance " "Movement of more than 5mm of tuberosity from post operative imaging for migration. any direction. resorption would be disappearance of tuberosity over time on radiographs" "Whether primary or secondary displacement of fragments" "> 3mm" "x ray" "Loss of reduction of the tuberosity from its position or its resorption" "Proximal migration into subacromial space; radiographical disappearance of the tuberosity" "Migration > 2mm on xray" "see above" "Greater tuberosity resorption or avulsion" "Displacement of the tuberosity of > 5mm when adding displacement seen on True AP and axillary views. " "Boileau JSES 11 (5), 401-12, 2002" "Any change in xrays appearance" "Migration or resorption that occurs post op" "Change in position of tuberosity from immediate post op X-ray/ reduction in size/ lysis of tuberosity"

Head necrosis
"Loss of specificity, cystic appearance, increase in density, MRI -CT observations" "Bone death resulting from poor blood supply to an area of bone" "Cruess Classification (stages) Stage I Normal x-ray. Changes on MRI. Stage II Sclerosis (wedged, mottled), osteopenia. Stage III Crescent sign indicating a subchondral fracture. .

Stage IV
Flattening and collapse. Stage V Degenerative changes extend to glenoid (2006) Classifications of necrosis of the humeral head. In: Classifications and Scores of the Shoulder. Springer, Berlin, Heidelberg""" "Deformity of humeral had or change of density" "Destructive image of the shape of the humeral head or condensation of the humeral head. In these cases I would request MRI" "Sclerosis or collapse on XR" "Secondary to AVN mainly four part proximal numeral fractures." "X-ray finding. MRI with metal suppression may help. " "Sclerotic and/or deformation with reduction in size of humeral head" "Sclerosis or fragmentation" "Comparison between immediate post-op x-ray and follow up exams and MRI " "Axial head collapse with secondary screw penetration Fragmentation of the humeral head fragment Signal changes in the humeral head MR for confirmation" "As compared to baseline standard radiological views and serial progressive x rays at definite time intervals, compare size of head" "Sclerosis with collapse and altered globularity of the head occurring up to about 18 months from surgery." "A pathological process that results from interruption of blood supply to the humeral head without relation to the type of fixation" "Structural changes of humeral head within 6-24 months" "New sclerosis, or lytic changes, or irregularities of the head" "Loss of area of >10% as determined from comparable AP images measured using maximum length & width of the head across anatomical neck and centre head to lateral cortex" "Radiological changes in the form and the appearance of the humeral head " "Head Collapse on subsequent X-ray" "Symptomatic or radiologically visible collapse. temporary loss of blood supply, such as on an mri scan, is not important or in the control of the treating surgeon" "Condensation deformation and / or collapse of the humeral head by radiographic control" "Avascular necrosis X-ray signs in head, lysis and sclerosis" "Change in shape of head " "Sclerosis the deformation " "Change in the integrity of the humeral epiphysis over time" "Sclerosis in X-ray of the head, or head resorption" "Increase in sclerotic subchondral bone across multiple XR. No reference" "Deformation of head or densification of head trabeculae" "Radiographically confirmed reduction of bone density of the head by 1.5-2 times from the adjacent bone with a decrease in its diameter, deformation of the shoulder joint and the axis of the humerus " "Collapse and screw protrusion, head resorption " "Reduction of the width of the humeral head on AP Xray or CT Scan Lacunar spaces on CT Scan Absence of signal on MRI" "For head necrosis I again suggest to adapt the definition by Cruess et al (1978) Experience with steroidinduced avascular necrosis of the shoulder and etiologic considerations regarding osteonecrosis of the hip. Clin Orthop Relat Res130:86-93" "Signs of AVN on Xrays and MRi with starting head collapse. " "Change in the shape, volume of the humeral head or the radiolucency of the bone in the region of the humeral head" "Cystic changes and/or sclerosis of the head, with or without head collapse" "Change in density / contour of the humeral head or development of subchondral fracture" "Loss of smooth contour of the head, with collapse and decrease in size on serial post op follow up Xrays" "On CT location/extent / % of the HH surface" "Any head necrosis detected by X-ray or CT or MRI" "Increased pain and a changes on the radiographs, which showed AVN -classified according to the system of Cruess. Cruess RL. Experience with steroid-induced avascular necrosis of the shoulder and etiologic considerations regarding osteonecrosis of the hip. Clin Orthop Relat Res. 1978;130:86-93" "Head necrosis confirmed by complementary test (x-ray, MRI or CT)" "Self explanatory. If found after fixation and not initially seen on plain radiographs To correlate Hertel's criteria 1. Posteromedial metaphyseal fragment size 2. Intact or disrupted medial hinge 3. Sub capital fracture or not" "Progressive destruction of the humeral head by trauma-related devascularization" "Loss of shape an alterations in bone density" "The head diminishes its size and losses its sphericity in the follow up. Areas of bone necrosis are found in the head or the joint surface becomes rough. It can affect to the whole head or just a segment. " "if the head structure loses his form -mostly seen in CT" "Head necrosis according to Fica classification via MRI and CT-scan and or x-ray" "Entmineralisierung und Entrundung des Humeruskopfes ggf. mit MR-tomographisch nachweisbarer Minderdurchblutung" "Collapse of humeral head" "Shoulder complaints (clinical signs) together with signs of necrosis on x-ray." "Loss of contours, shrinking and deformation of head, irregularity of head articulation" "Collapse of the humeral head with sclerosis of the subchondral bone" "Any change to post-operative X-ray no matter the size or location. " "This is not clearly and uniform defined by different authors, thus reports of HN is very uneven. To me it means 1) a clear and visible change in the trabecula in the head at" "Loss of shape and change in density of head" "Classification acc. Cruess RL (1986) Osteonecrosis of bone. Current concepts as to etiology and pathogenesis. Clin Orthop 208: 30-39" "Deformity of the humeral head secondary a loss of vascularization due to surgery or fracture" "Loss of contour of the head and/or collapse"

Delayed union / nonunion
"Failure to appear callus after 3 months" "A nonunion is an arrest in the fracture repair process. A delayed union is defined as a failure to reach bony union by 6 months post injury" "No show union as minimal in 3 months post surgical. " "Delayed visibility of bone healing after expected period of time appropriate for shoulder fracture" "Absence of bone callus formation after 6-8 months from the fracture, and unchanged with respect to previous radiographs. In these cases I would check diagnosis with CT scan" "Shift in fracture or hardware " "Absence of healing beyond six weeks for delayed union and beyond six months for nonunion." "Time : 3, 6, 9 months?" "X-ray and CT scan" "Persistence of fracture line after three (3) months" "Based on serial X-rays and no signs of progressive healing" "Comparison between immediate post-op x-ray and follow up exams" "Persistence of fracture line at the level of surgical/ anatomical neck Implant failure Tuberosity migration" "16 weeks" "As compared to baseline standard radiological views and serial progressive x rays at definite time intervals, see for progress of union standard definitions of Delayed and non-union" "No / very slow progress of callus score. Especially the medial continuity which might require intervention." "Delayed union is a failure to reach bony union by adequate time post-injury non-union is permeant failure of healing mostly to the surgical neck and tuberosity fracture" "Signs of lack of healing after 3-6 months" "Not united between 2 and 6 or later than 6 months Question is how to define bony union: at least three cortices do have bony contact now" "Non union -failure to show progression of healing for >\= 3 months after 4 months or more from injury Delayed union -not clinically or radiologically healed after 4 months from injury" "Absence of bony union, persistence of fracture lines on post-operative X-rays taken at 12 weeks or later post-operative" "After 6 months" "Failure of healing by 6 months or loss of position of implant/bone at any stage" "Nonunion of the fracture after 6 months" "The lack of bone passage in the fracture site with increased gap in the fracture line" "Usual definition" "Delay-no callus formation in 8-12 wks Nonunion-no callus in 6 months at fracture site" "Delayed fracture healing more than 6 months " "Failure to unite over a usual time for healing" "Noted delayed progression of fracture healing by treating surgeon" "No bridging callus at 3 months delayed. At 9 months nonunion." "No evolvono bone formation" "The lack of radiological and clinical signs of Union of bone after 8 to 12 weeks from the date of injury or surgery" "Gap and lines with sclerosis between the fragments. " "Lack of progression of healing on consecutive XR checks 6 weeks apart after the 6 month mark" "As delayed non-union our used definition is radiological non-union after three months, while a non-union is radiological non-union after six months of treatment. Non union may radiologically be confirmed by the RUST criteria as used for tibial noon-unions (Kooistra et al; J Orthop Trauma 2010;24:S81-S86)" "Delayed 4 months, nonunion of fracture (still visible on CT without bridging callus more than 6 months" "Absence of the appropriate signs of the fracture healing on x-ray and CT scan in all fracture lines." "No progression of callus after 3 months" "Delayed -failure to show any signs of healing for at least 6 months. Non-union -lack of progress of healing on sequential x-rays beyond 6 months or no evidence of healing at 12 months and confirmed on CT scan. " "More than 6 months after fracture, an open fracture gap visible on X-ray, resorbed fracture ends or hypertrophic callus with an open fracture line. Clinically, abnormal mobility at fracture site with or without pain." " CT " "Any non-union detected by X-ray or CT after 6 months from injury or operation" "Delayed healing -if there was failed consolidation radiographically 4 months after trauma. Non-union after 6-8 months after trauma." "Delay: A fracture without signs of union after 4 months. Non-union: A fracture without signs of callus progression within 6 months." "Union not occurring in three months ( Delayed union ) Union not occurring in six months ( Non union )" "Late or no consolidation after six months" "non-union: a fracture that do not shows signs of healing on 2 consecutive x rays after the given period of healing and related to clinical symptoms " "Loss of progression of bone union" "There is lack of trabecular continuity through the fracture fragments. The borders of the bone fragments appear to be ossificated. Sometimes a proper joint can be found." "not healed after 12 weeks -delayed not healed after 6 months -non-union" "No signs of healing 3 months postop and non-union no signs of non-healing 6 mths opostop verified by CT-scan" "Ausbleibende knöcherne Heilung über 6 Monate nach Fraktur hinaus" "non-union -no bone healing 6 months following fracture treatment (no progression in healing over 3 month period) delayed union -incomplete bone healing at 6 months" "delayed Union: no cortical bone healing of at least 3 cortices in 2 directions on x-ray at 6 months. non-Union: no cortical bone healing of at least 3 cortices in 2 directions on x-ray at 9 months" "Non-union scoring system; Weber & Cech" "Failure to union after at least 4 months" "According to well established definition" "Non-op: Delayed union: >2 months Non-op: Non-union > 4 months (?) ORIF with locking plate: Consolidation expected longer: Difficult to state delayed union, but >12 months non-union" "No changes in fracture line in subsequent Xray" "DOI: 10.1097/TA.0b013e3181469840 doi: 10.1097/01.blo.0000195679.87258.6e , " "Non-healing of the fracture after six months in case of non-union or non healing in the first months after the fracture. " "Beyond six months" "esp in subcapital fractures, mostly regarding tuberosities" "Fracture line in AP view visible > 3 months post trauma" "Non union after 9 months delayed is union between 3 months and 6 months" "As above" "If clinical signs after 4 months or fracture gap without bridges after 4 months X ray" "Only if affects joint surface" "Healing not achieved in expected time/ healing not achieved in time 2 times longer as is needed for fracture healing " "Radiographs -difficult as per Morshed, Adv Med 2014 " "Any fracture that does not heal in 9 months (non union) or does not progress in 3 months follow up" "Lack of evidence of the fracture moving as a unit by 6 weeks postfracture (nonoperative) Lack of evidence of bony healing by 6 months after fixation/arthroplasty" "Time period is controversial May add atrophic vs hypertrophic Infected vs non infected " "Persistent or increased fracture gap through time" "No callus formation at the three months after the injury." "Fracture that will not heal without further intervention" "X-p" "NON-UNION after passing the expected time for union around 6--8 weeks " "Delayed union: no bridging callus on x-ray 6 weeks after the fracture occurred. Non-union: no evidence of bridging callus 8 weeks after the fracture occurred. " "Delayed union = absence of fracture healing after 6 months but with healing progression Non-union = no fracture healing after a year" "The extra time taken by the bone to heal over the normal healing period" "In fractures with medial comminution we get delayed union" "Shaft fractures" "Lack of bridging of at least one cortex at 3 months" "Delayed union -healing of fracture later than 3 months after injury. non-union -not healed fracture with signs of instability either clinical or radiological later than 6 months after injury, with no healing signs on repetitive x-rays" "Delayed Union: Union time longer than expected for a metadiaphyseal fracture (6-12 weeks) Nonunion: no healing after a delay of 6-9 months with pseudo-arthrosis formation" "Time interval non union zone measurement" "Xrays at 6 months" "No sign of clinical or radiological healing by 3 months" "Failure to obtain clinical and radiographical union at 3-6 months postoperatively or after non operative treatment" "No signs of bone healing of the fracture in both views within 3 months (delayed) or 6 months (non-union)" "After six months with no consolidation " "Delayed union -Absence of bridging bone tissue across the fracture within 6 months of treatment duration. Non-union -Failure of serial radiographs to show progression of healing." "No progression of healing for 3 months or not healed by 6 months" "non union: non-healing of the fracture 6 months after treatment " "delayed-absence of union at 4 months nonunion-absence of healing at 6 months" "Delayed union: absence of osseous union 12 weeks after fracture/ treatment, however with increasing callus formation on later follow-up X-rays. Non-union: absence of osseous union 20 weeks after fracture/ treatment with increasing bone resorption in fracture gap on follow-up X-rays." "Delayed union is past 4 months. nonunion is failure of fracture consolidation after 6 months with no progression on radiographs in consecutive months." "Documented clinically and radiologically" "Delayed > 6 weeks, non-union 3 months" "x ray" "When fracture fails to unite in 3 months will be delayed union and if it fails to unite in 6 months as non union" "Delayed -absent adequate bridging callus after or persisting symptoms after 6 months; Non-union same after 9 months" "Persisting open fracture line after 6 months or surgery for non-union" "see above" "Nonunion of the humeral head with varus collapse" "Delayed union: lack of distinctive healing at 3 months. No union: lack of progressive healing at 2 consecutive radiographs at one month intervals after the third month, or lack of conclusive healing at 6 months. " "No callus or hypertrophic callus and visible fx line after > 3mt" "delayed: lack of healing at 6 months but with continued progression on xrays nonunion: surgeon opinion that fracture is unlikely to heal without further intervention" "Sclerosis or collapse of the articular surface of the humeral head post op" "Delayed-no evidence of union -characterised by persisting fracture gap after 8-10 weeks of treatmenteither operative/ conservative"

Fracture malunion
"Loss of reduction and rotational malalignment" "Fracture has healed, but that it has healed in less than an optimal position" "The HSA was measured at the intersection of the tangent line of the articular surface with a line parallel to the long axis of the humeral shaft, as previously described. The humeral head height (HHH) was measured on the anteroposterior radiographic image by calculating the vertical distance between the tangent line of the highest point of the humeral head and the greater tuberosity L. Bai, et al Radiological evaluation of reduction loss in unstable proximal humeral fractures treated with locking plates, Orthopaedics & Traumatology: Surgery & Research, Volume 100, Issue 3, May 2014, Pages 217" "No visible bone healing or x ray and other radiographic studies , after expected period of time appropriate for shoulder fracture" "Healing of the fracture in bad position, either in varus or with greater tuberosity posterior o high" "Angulation as above" "Any healing losing normal humoral head and neck anatomy in any plane." "Definition?" "xray and CT scan" "Union of fragment(s) in nonanatomic position" "Angulation/displacement" "Comparison between immediate post-op x-ray and follow up exams and CT scan" "Non-anatomical tuberosity position with evidence of impingement Varus > 10* (compared to opposite side) " "As compared to baseline standard radiological views and serial progressive x rays at definite time intervals, see for the malunion" "1. altered head to tuberosity distance 2. > 20° varus of head neck shaft angle" "Union of the fracture in less optimal position most common malunion of the GT " "Classification according Boileau" "see definitions ahead" "Healing of any part greater than the deformity to constitute a Neer fragment" "Fracture union with malposition of the main fragments: -humeral head varus -humeral heal valgusgreater tuberosity above the pole of the humeral head" "Difficult. see my previous answer" "Varus or valgus, Anteversion or retroversion of head from normal more than 30 degrees. Migration of tuberosity healed in displaced position." "Angle of 40-60 degree at fracture site" "Angulation" "Improper position of fracture parts after healing" "Noted by surgeon by inadequate fracture healing position" "Articular surface in greater than 30 degrees angulation on Y-axilary or grashey AP. NO reference" "Union in a non-physiological or normal anatomic manner " "Radiological signs of bone tissue restoration at the fracture site" "Loss of normal anatomy of the proximal humerus" "Malunion should be defined according to malreduction using the following criteria according to Schnetzke et al: good quality of reduction/alignment: head-shaft angles of 110-150°, <5mm head-shaft dislocation, and <5mm displacement of the major tubercle . Poor reductiono/malunion: varus <110° or valgus >50°, >5mm head-shaft dislocation, or >5mm displacement of the major tubercle (Schnetzke +, Rate of avascular necrosis after fracture dislocations of the proximal humerus; obere Extremität 2018 · 13:273-278 https://doi.org/10.1007/s11678-018-0452-6)" "Angulation of the head / neck >10 degrees or displacement of the fracture fragments and healing in this wrong position.> 5mm" "Fracture healed with displacement or malalignment which exceeds the angulation of 10 deg, tuberosity displacement over 3 mm and surgical neck displacement more than 1 cm." "Greater than 5 degrees of varus and sagittal plane alignment greater than 10 degrees of valgus or axial rotation greater than 5mm shortening" "Evidence of healing in a malreduced position e.g. 1. If the GT sits higher than the humeral head on the AP view. 2. >20 degrees varus angulation 3. Sagittal plane angulation > 20 degrees 4. Overlap between tuberosities and articular surface" "Varus or valgus malposition of the head with the shaft (after union), high riding tuberosity, and rotational mal-alignment with improper restoration of version." "CT angulation/displacement in coronal and sagittal plane " "Fracture healing in position which can lead in malfunction of shoulder. Valgus, varus malposition of head, malposition of tubercule more than 5mm, rotational malposition." "More than 5 mm of displacement in tuberosities. Non anatomical reduction of calcar. More than 2mm of gap in fracture" "Any change in fracture position after surgery, as previously described in Lill's criteria" "Consolidation of the fracture in a non anatomical position" "Bone union in a position causing functional impairment" "Either fracture fragment heals in a position that may affect function afterwards: greater tuberosity over the head or posteriorly, lesser tuberosity medially blocking internal rotation, or the head tilted to anterior or posterior, or in unacceptable valgus." "Rotation Valgus or varus more than 20 ° with clinical manifestation" "Healing of the proximal humerus with head-shaft alignment of <110° or >150°, or healing of the displace tuberosity >5mm and <10mm Schnetzke M, Bockmeyer J, Porschke F, Studier-Fischer S, Gruetzner P-A, Guehring T Quality of Reduction Influences Outcome After Locked-Plate Fixation of Proximal Humeral Type-C Fractures, J Bone Joint Surg Am. 2016;98:1777-85" "Heilung in Fehlstellung mit daraus resultierender Funktionseinschränkung" "Displacement of fracture more than 1 cm angulation more than 45 degrees" "Union in an non-anatomical position with complaints" "Axis position out of defined ranges differentiate from non union" "Bone healing with humeral head in varus, anteversion, retroversion, displaced anteriorly or posteriorly respect the metaphysics and diaphysis" "According to well established definition" "Inclination > 10-15 degrees valgus or varus (AO 2007) Scapula Y view: 10-15 degrees apex ant. or post. Tuberosities: Greater T: >10mm Lesser T: >10 mm Contact between diaphysis/ metaphysis and head: <2/3" "Abnormally aligned fracture fragment either since inception or subsequent development" "doi: 10.1097/01.blo.0000195679.87258.6e" "Malaligned fracture healed" "Often in conservative treatment" "varus/valgus malposition of tub majus" "As above" "Healed with more than 20 degrees difference compared with anatomical angles or tuberosity displacement more than 0,5 cm. Impaction more than 1 cm or translation more than 20%" "noted before" "Fracture healed in non-appropriate position " "Any varus, antecurvatum or recurvatum" "Healing in varus (neck shaft angle < 120), Healing with tuberosity displacement more than 5 mm Healing with greater than 50% translation of the humeral shaft " "Obvious" "Fracture healing with non-tolerated displacements" "Neck shaft angle discrepancy compared with the uninjured side more than 15 degrees" "Fracture healed in unfavorable position" "X-p" "Union in a way affecting the function of the whole limb and/ or affecting badly the appearance and shape of the arm" "More than 3cm shortening or more than 45 degrees of angulation " "Healing of the fracture in a position corresponding to a >1 part-fracture according to Neer" "The degree of angulation or translation of the bone fragments with respect to each other" "Fracture fixed in malposition " "Head & neck fractures in Varys / valgus" "Healed fracture in 10 deg varus or 15 deg valgus, or tuberosity 5 mm displaced" "The fracture healed in the non-anatomical situation, which is visible on x-ray. there can be different grades of malunion" "Healing in a position deviating 25 degrees from the normal anatomy" "Radiographic measurements (CCD, AHD, ...)" "Xrays at 6 months" "Angulation over 45 deg, tuberosity healing in migrated position " "Varus or Valgus more than 10 degrees than the normal shoulder, GT impingement " "Non-union of the fracture with severe displacement a) Greater tuberosity below the level of the cortex or a side-to-side difference <5 mm (b) No increased varus or valgus (+/-15°) of the head fragment in the anteroposterior view (c) No increased retro-or ante torsion (+/-15°) of with a severe displacement of the n both views " "Apparition of atrophic callus" "Any alteration in shape of proximal humerus geometry with opposite side as template." "Greater than 20 degrees angulation in any plane, greater than %50 translation in any plane" "Healing of the fracture in a non-anatomic way" "Malunion-tuberosity proximal to superior margin of articular surface varus or valgus position in of humeral head" "Fracture union in any position which is not anatomical." "Will be honest, not sure I know how to best define this." "Unacceptable angulation and displacement" "Rotation > 25°, axis > 20°" "X-ray + CT" "When the humeral head or tuberosities unite in wrong place radiographically" "Union in an inadequate position with interference in function" "A score combining intraarticular displacement and varus/valgus displacement" "see above" "Screws pull out or broken material" "Change in position of fracture fragments -head, tuberosities or shaft when compared to immediate postoperative image." "Greater than 20 degrees angulation in any plane, greater than %50 translation in any plane" "Fragments mobilization " "Failure of current treatment to maintain alignment" "Secondary displacement of fragments on postoperative follow-up X-rays as compared to the final documentation after fracture reduction (and fixation, if applicable)" "Shift of fracture alignment of more than 5mm in any direction after conclusion of surgery" "Primary or secondary" "x ray" "Increase/ decrease in varus, valgus, retroversion flexion, extension in subsequent radiographic picture as compared to before" "Change in the fragment relative position, from a previous radiographic control, in an x-ray performed in the same position and conditions" "A score combining intraarticular displacement and varus/valgus displacement" "see above" "Cut out of fracture fragments" "Fracture that no longer meets criteria for fracture reduction established intraoperatively. " "Measured in part-criteria according to Neer" "Change in alignment after surgery" "Progressive loss of reduction on serial x rays" "Loss of anatomical reduction in post-operative follow up period, which was not evident in immediate postoperative X-rays loss of initial reduction achieved after closed reduction in conservatively managed fractures" Specifications : -Subluxation : non arm position-dependent eccentric misalignment with residual contact.
-Dislocation : non arm position-dependent complete loss of contact of the articulating surfaces.
-Dynamic instability : arm position-dependent loss of contact of the articulating surfaces apparent on physical examination and/or visible on functional radiographs (horizontal flexion/extension view in 90° of abduction and true AP view in 60° of abduction Other time period ‡ 7 (5%) † Other time period in joint-preserving fracture fixation: "1 month" "3 months" "3-4 months" (2) "postoperative to six months" "Until fracture healing, when the patient obtained the maximum expected ROM" "18 months" ‡ Other time period in non-operative treatment: "1 month" (2) "Start of treatment till three months" "3-4 months" "Until fracture healing, when the patient obtained the maximum expected ROM" "18 months" "lifelong"

Comments and suggestions
"it is an issue in semi-total or RSA treatment more than after joint preserving surgery" "at 3 months" "Usually in non-operative cases , we get subluxation , proximal migration of GT , delayed union , nonunion, loss of function" Comments and suggestions "Regarding regional anesthesia" "Period of observation can be more than 3 months" "I would recommend to have a longer period of observation, also 2 years" "Extending time to 6 or 12 months as these evolve" "Very difficult to diagnose CRPS type II before fracture healing. CRPS should be classified apart. Neurological unfavorable events beside CRPS are exceptionally caused by non-operative treatment." "How can we differentiate between axonotmesis and neurotmesis if we do not explore surgically the nerves" "Maybe the period for observation of CRPS should be extended to 6 months." "Electromyogram after 3 weeks postoperative followed by a minimum of 6 months." "It should be documented whether the injury is post-fracture, or preoperatively, or postoperatively." "Also for 12 months (at least), i.e. during observation period (CRPS!)" "Observation period should be 12 months for Brachal plexus injuries, and 6 -12 months for branch neuropathy" "CRPS may be a social construction. It's a theory that posits an as yet elusive pathophysiology in people with disproportionate pain and limitations. Mounting evidence suggests that symptoms and limitations are accounted for by stress, distress, and effectiveness of coping strategies without the need to posit an elusive pathophysiological explanation, nervous system or otherwise. " "Newer methods of documenting changes in blood flow to a peripheral nerve, MRI neurography can also be considered, which supposedly claim to be more accurate." "Until palsy improves May take longer in plexus injury" "Maybe we could evaluate clavicle nerves as well" "Period of observation should be 6 to 12 months" "Consider type of anaesthesia (regional!) " Comments and suggestions "add vascular section and/or hemorrhage" "If the definition includes 'surgical site' Venous Thrombosis should be categorized apart." "One should exclude harm to the cephalic vein intraoperatively as this occurs very commonly." "Non Op also will need if the fracture displaces and a new vascular injury is caused" "See previous comments " "In definition we can add ----at the surgical site / injuries occurring as a result of primary injury / sequelae of conservative treatment" "Not all events have the same importance: an injury to the axillary artery might be life-threating while an hematoma due to anticoagulant medication, can be a mild adverse event. The repercussions, the timing for diagnose and treatment are completely different. I would somehow consider the level of importance." "also for total observation period, at least 3 months" "Aneurysm " "ignore the haematoma bit" "Conservative management can cause allergies related to material of treatment with conservative means like a sling/ plaster/ cotton/ cloth. This may also cause axillary infections which although will not be SSI but may be important to study the impact and risks of non conservative treatment in the study" "Only in cases of associated wounds, whose treatment or evolution might impact rehabilitation, immobilization or function" "Any skin or deep infection, for example, from an abrasion that requires oral or IV antibiotics" Comments and suggestions "I'd suggest 4 weeks period for early infection; 4-10 weeks for delayed and more than 10 weeks for late. Trampuz A, Zimmerli W. Diagnosis and treatment of infections associated with fracture-fixation devices. Injury 2006;37(Suppl 2):S59-66. Willenegger H, Roth B. Treatment tactics and late results in early infection following osteosynthesis. Unfallchirurgie 1986;12:241-6." "Early infection should be less than 6 weeks" "Complications in conservative treatment should be addressed as external device complications. FRI criteria may be included." "Usually SSI is defined as infection within 30 days, therefore early can be specified within 30 days late within 30 days to 03 months and low grade 03 to 24 months" "max 12 months deep infection can only be detected on Revision Operation, that means that this is obligatory. Otherwise it will be superficial with only AB" "to be discussed: 6 weeks limit for early infection risk of maluse of the definition 'superficial SSI' by surgeons!" "Time line should be -till implant is in place and local tissue status at time of removal of implant for various reasons" "There is no way to distinguish superficial and deep infections." "early infections < 45 days in orthopedics rarely to speak for superficial site infection " "Time period of deep SSI should be increased, up to 36 months." "Use Pro Implant Infection definition, much more appropriate or as published in Injury last year as consesus of experts ! Not this one !" "The issue of SSI is data capture as length of stay is now very short in hospitals. The secondary issue is how would one capture community data, as once discharged the patient would most likely be seen by their local medical officer." "Since bacterial flora is different in shoulder may involve all non unions too" "k" "Local infections should be documented if it is an open proximal humerus fracture " "I think 12 months is sufficient for infection" "Differentiation between early and late infections according to specific definitions used for operative fracture treatment (i.e. early = less than 6 weeks after intervention)" Comments and suggestions "Non-op treatment could have extensive hematoma that leads to some scar formation." "We must document however any superficial bruising (infected or not), which cause a delay or even no operation." "Ulcers/pressure sores/skin necrosis caused by immobility from splints/slings etc are consequence of treatment choices by the surgeon" "Keloid develops sometimes with no infection" "The timeline for early events should include events appearing right after the trauma: this means we should consider open fractures as a superficial soft tissue event. Unless open fractures are registered in another complication definition." "Cave superficial vs. deep infection scar quality has to be registered independent from infection" "Too inclusive. Edema is routine." Other time period ‡ 10 (6%) † Other time period in joint-preserving fracture fixation: "1st to 4 weeks " "Within three weeks " "6 weeks" "1 and 3 months after fracture" "<3 months, keeping in mind the occurrence of infection as one of the soft tissue events" "Until healing" "18 months" ‡ Other time period in non-operative treatment: "3 to 4 weeks" "1 and 3 months after fracture" "3 months" "5 years" "None" "Until healing" "Until bone healing " "18 months" "N/a" "Likely not needed for non-operative"