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Table 1 Characteristics of the Included Pilot RCTs

From: Pilot randomized controlled trials in the orthopaedic surgery literature: a systematic review

Title Country # of patients Condition Type of Surgery Control Patient-Reported Outcomes Clinician Reported Outcomes Primary Outcome Secondary Outcome Loss to follow-up (%) Length of follow-up Feasibility Category Framed as feasibility? Definitive Trial Published? CLEAR-NPT Score
Hamdy, R. C et al., (2009) [15] Canada 52 Lower extremity limb lengthening and deformity correction. Ilizarov technique Sterile saline solution Faces Pain Scale-revised, Adolescent Pediatric Pain Tool, Pediatric Quality of Life Inventory, Gillette Functional Assessment Questionnaire n/a Pain, quality of life, functional mobility Adverse effects 3% 3 mo Study design Yes Yes 17
Vaccaro, A. R et al., (2005) [16] USA 12 Iliac crest autograft in posterolateral lumbar fusions Op-1 putty (rhbmp-7) as an adjunct No control group Oswestry scale and SF-36 Radiographic Fusion success rate Cost effectiveness and pain 0% 24 mo Safety & efficacy Yes No 11
Ekrol, I et al., (2008) [17] UK 30 Distal radial fractures. RhBMP-7 as an alternative to bone graft healing No control group n/a Radiographic, clinical and functional outcomes Functional outcome Complications 0% 12 mo Efficacy Yes No 18
Lerner, T et al., (2009) [18] Germany 40 Adolescent idiopathic scoliosis. Graft extenders in scoliosis surgery No Control Group VAS pain score Biopsies Fusion success rate Pain 0% 48 mo Efficacy Yes No 15.5
Marks, P et al., (2008) [19] Canada 40 ACL reconstruction Comparing the Mitek bone–tendon– bone cross pin and bioabsorbable screw No control - comparative trial International Knee Documentation Committee (IKDC) Knee Ligament Standard Evaluation, Mohtadi’s ACL Deficiency Quality of Life Lateral x-Ray Clinical outcomes Length of surgery 20% 24 mo Efficacy Yes No 16.5
Shamji, M. F et al., (2014) [20] Canada 23 Thoracolumbar burst Applying a brace to treat thoracolumbar bursts No brace VAS pain score Radiographic, clinical & functional outcome Average length of hospital stay & cost Pain & adverse effects 0% 6 mo Efficacy Yes No 14.5
Carson, J. L et al., (1998) [21] UK 84 Hip fracture Blood transfusion during hip fracture No Control- comparative trial Phone interviews of family or patient Various methods to evaluate adverse effects (CT scan, ultrasound, autopsy) Mortality & ability to walk 10 ft across a room Functional status, residence status, in-hospital myocardial infarction,thromboembolism, stroke and pneumonia. 3% 60 days Patient recruitment Yes No 16.5
Vaccaro, A. R et al., (2003) [22] USA 12 Iliac crest autograft in posterolateral lumbar fusions Op-1 putty (rhbmp-7) as an adjunct No control group n/a Radiographic & clinical Fusion success rate Adverse effects 0% 24 mo Safety & efficacy Yes No 13.5
Vaccaro, A. R et al., (2004) [23] USA 36 Symptomatic degenerative spondylolisthesis Spinal stenosis Autograft n/a Radiographic & clinically Fusion success rate Well-being/Quality of life 5% 1 yr Safety Yes No 18
Glazebrook, M et al., (2013) [24] Canada 24 Ankle and Hindfoot Arthrodesis B2A-Coated Ceramic Granules (Amplex) Compared to Autograft Autograft Computerized tomography & Ankle Osteoarthritis Scale scores n/a Bone healing at site of fusion n/a 0% 12 mo Safety & efficacy Yes No 17
Mauffrey, C et al., (2012) [25] UK 24 Tibial fracture Arthrodesis surgery No control - comparative trial Functional outcome questionnaire (DRI) n/a DRI Olerud and Molander Ankle Score (OMAS)10 and the EuroQol EQ-5D generalized health outcome questionnaire 0% 12 mo Efficacy Yes No 18
Darmanis, S et al., (2007) [26] UK 40 Knee arthroplasty Knee arthroplasty No laser Fisher’s Exact test and the Mann-Whitney U test n/a Fisher’s Exact test and the Mann-Whitney U test n/a 0% n/a Efficacy Yes No 15.5
Buse, G. L et al., (2014) [27] Canada 60 Hip fracture Accelerated surgery No Functional Independence Measure & SF-36 Troponin measurement & confusion Assessment Method. Proportion of eligible patients randomly assigned, completeness of follow-up & timelines of accelerated surgery Major perioperative complication 0% 18 mo Sample size Yes No- Ongoing Definitive Trial 15
Adolfsson, L et al., (2001) [28] Sweden 53 Waist Percutaneous Acutrak screw fixation. Immobilization in a below elbow plaster cast for 10 weeks n/a Radiographic Assessment of union Failure 1% 10 wks Efficacy Yes No 16.5
Kang, P et al., (2012) [29] China 77 Femoral Multiple drilling core decompression combined with systemic alendronate as a femoral head-preserving procedure Multiple drilling core decompression THA & Harris score Radiographic Efficacy of combined treatment Reduction in disease progression 10% 48 mo Safety & efficacy Yes No 17
Moseley, J. B et al., (1996) [30] USA 10 knee Arthroscapic surgery of the knee Placebo (sterile saline) Arthritis Impact Measurement Scale 34 and the SF-36 n/a Evaluate the placebo effect as part of a pilot trial preceding a randomized, controlled trial of arthroscopic treatment of osteoarthritis Ability to find and recruit eligible subjects; developing and testing measurement instruments; ability to retain patients for at least 6 months; determine feasibility of completing trial 0% 12 mo Ability of patients to complete the trial; ability to maintain blindness Yes No 18
Chhabra, H. S et al., (2009) [31] India 5 Spinal cord Olfactory mucosal transplantation into the spinal cord No American Spinal Injury Association (ASIA) Impairment Scale (AIS), Spinal Cord Independence Measure, Beck Depression Inventory scores and life impact scores on International Spinal Cord Injury Scale MRI Autologous olfactory mucosal transplantation therapy n/a 0% 18 mo Safety & efficacy Yes No 16
Wang, Y et al., (2015) [32] China 21 Foot Total-contact casting (TCC) No Quantitive sensory Testing (temperature, pain, light touch, perception) Radiographic Comparing the effectiveness of arthrodesis plus TCC with TCC alone for the prevention, treatment and recurrence of midfoot ulcerations Sample size 0% 12 mo n/a No No 18
Zou, J et al., (2013) [33] China 94 Tibial Minimally invasivepercutaneous plate osteosynthesis Comparative trial, control group was treated with ORIF n/a Radiographic Functional status Sample size 0% 12 mo n/a No No 16.5
Zehir, S et al., (2015) [34] Turkey 45 Clavicular Minimally invasive plating fixation Mini invasive plating (DASH) Quick Disability of the Arm, Shoulder and Hand Radiographic Efficacy Sample size 0% 12 mo Efficacy Yes No 16.5
Pang, H. N et al., (2011) [35] Singapore 140 Knee Knee arthroplasty Resection technique Knee Society Score [20], Oxford Knee Questionnaire [36] and SF-36 Questionnaire Radiographic Efficacy Unclear 0% 24 mo Efficacy Yes No 18
Wondrasch, B et al., (2009) [36] Austria 21 Femoral Matrix associated autologous chondrocyte implantation Delayed weightbearing Knee Documentation Committee (IKDC), the Tegner activity scale, and the Knee Injury and Osteoarthritis Outcome Score (KOOS) Radiological outcome was evaluated by the MOCART score and the size and amount of bone marrow edema and effusion Efficacy n/a 0% 24 mo Efficacy Yes No 14
De Sèze, M. P et al., (2011) [11] France 28 ankle ankle foot orthosis Standard ankle-foot orthosis Pain evaluation on an analogical visual scale n/a Gain ratio at day 30   0%   Efficacy Yes No 16
Kraus, V. B et al., (2012) [37] USA 11 Knee ACL Placebo (sterile saline) Standardized Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire n/a Efficacy Sample size 0% 1 mo Efficacy Yes No 16
Flow Investigators (2011) [38] Canada 111 General open fractures Fracture healing Saline SF-12 and EQ-5D, respectively (12-item questionnaire that measures health-related quality of life in 8 domains) n/a Reoperation rates Infection & wound healing problems 11% 12 mo Efficacy & large scale trial Yes Yes 18
Lindsey, R. W et al., (2006) [39] USA 10 General long bone fractures Grafting long bone fractures No n/a Radiographic Effectiveness of a composite graft consisting of demineralized bone matrix (DBM) putty enriched with aspirated bone marrow Sample size 0% 24 mo Efficacy Yes No 16
Costa, M. L et al., (2003) [40] UK 28 Achilles tendon Achilles tendon ruptures Serial plaster casting n/a Ultrasound Safety Sample size 29% 12 mo Safety Yes Yes 18
Mahowald, M. L et al., (2009) [41] USA 11 Advanced rheumatoid arthritis and osteoarthritis IA-BONT/A Saline Placebo Patient global assessment of change was measured with a validated 7-point verbal descriptor scale & WOMAC n/a Efficacy and safety of IA-BoNT/ Decreases in pain and functional improvement 13% 1 mo Safety & efficacy Yes No 12
Paterson, K et al., (2013) [42] Australia 37 Knee PA-PRP Hyaluronic acid VAS pain score n/a Recruitment and safety data Symptomatic and functional changes following treatment 17% 4 and 12 wks Efficacy Yes No 18
Zehir, S et al., (2014) [43] Turkey 64 Distal radius fractures Sonoma Wrx Standard volar locking plate fixation n/a Radiographic Reliability and efficacy Complication prevention 0% 12–13 mo Efficacy Yes No 13.5
Hey, H et al., (2013) [44] Singapore 7 Spinal Hybrid surgery Anterior cervical discectomy and fusion + artificial disc replacement Complications and functional scores (VAS, NDI, EQ-5D health score and index) n/a Clinical differences between three groups n/a 0% 2 wks Safety & efficacy Yes No 10.5
Kuo, L. C et al., (2013) [45] Taiwan 22 Radial Early digit mobilization Home programmes Manual Ability Measure-36 (MAM-36) to assess their self-awareness of manual abilities Radiographic Differences in functional outcome n/a 0% 12 wks Efficacy & cost Yes No 18
Abbott, A et al., (2013) [46] Sweden 17 Cervical With post-operative cervical collar usage Without post-operative cervical collar usage Falls Efficacy Scale (patients measuring completing tasks without falling) Radiographic Sample size feasibility Physical, functional, and quality of life-related outcomes 45% 6 wks Cost & sample size Yes No 12
McMorland, G et al., (2010) [47] Canada 120 SCIATICA Surgical microdiskectomy Standardized chiropractic spinal manipulation McGill Pain Questionnaire, Aberdeen Back Pain Scale, and Roland-Morris Disability Index) n/a Recruitment and randomization process, choice of outcome measures, and effect size for definitive trial Compare the clinical efficacy 0% 1 yr Sample size patient recruitment randomization Yes No 18
Ringel, F et al., (2012) [48] Germany 60 Spinal Robot-assisted (RO) implantation Freehand (FH) conventional technique n/a CT scan Evaluate accuracy of techniques n/a 0% No follow up Efficacy Yes No 16
Boonen, S et al., (2002) [49] Belgium 33 Proximal Femoral Fracture Administration of rhIGF-I/IGFBP-3 Placebo Kerr-Atkins score for pain and function Radiographic Pain and function Musculoskeletal effects 0% 6 mo Safety Yes No 17
Griffin, D et al., (2014) [50] UK 151 Calcaneal fractures Surgery by open reduction and internal fixation Non-operative treatment Kerr-Atkins calcaneal fracture score Radiographic Pain and function Complications 5% 24 mo   No No 18
Guo, Q et al., (2013) [51] China 90 Intertrochanteric fractures Percutaneous compression plate Proximal femoral nail anti-rotation n/a Radiographic Clinical effectiveness Complications 0% 2 yrs   No No 16.5
Storey, P et al., (2013) [52] UK 49 Carpal Tunnel C-Trac splints Conventional resting splint n/a Radiographic Levine questionnaire scores Grip, pinch and sensation scores 0% 1 yr   No No 14
Zhang, Y. Z et al., (2011) [53] China 22 Abnormalities with hip joint Navigation template implantation Conventional THA n/a CT scan Unclear Unclear 0% 12 to 18 mo   No No 13
Nejrup, K et al., (2008) [54] Denmark 43 Knee osteoarthritis Gold implantation Sham implantation WOMAC, Knee Society Clinical Rating System Radiographic Knee pain, stiffness and function Time from implant until effect and migration potential of implanted gold beads. 7% 0, 6 and 12 mo   No No 18
Eskander, M. B. F et al., (1997) [55] UK 44 Femoral neck fractures Enoxaparin Application of intermittent calf compression garments n/a CT scan Unclear Unclear 0% 6 wks   No No 16.5
Jordan, R et al., (2014) [56] UK 24 Tibial plateau fractures Balloon osteoplasty Traditional methods Oxford Knee score and SF12 questionnaire at 3, 6 and 12 month CT scan Quality of reduction based on the post-operative CT scan Surgical complication & patient satisfaction Not stated 3, 6 and 12 mo   No No 18
Kearney, R. S et al., (2011) [57] UK 52 Achilles tendon rupture Surgical repair Non-surgical repair Disability rating index EQ-5D, Achilles Total Rupture Score n/a Estimate of effect size for the functional outcome Assess the use of a comprehensive cohort research design 10% 2 wks, 6 wks, 3 mo, 6 mo & 9 mo Study design Yes No 10
Sabeti, M et al., (2014) [58] Austria 20 Calcific rotator cuff tendinitis Intraoperative ultrasound Needling and palpating techniques n/a Radiographic Notable potential clinical differences between the two groups Clinical improvement using ultrasound 10% 2 and 6 wks and the 9 mo   No No 13
Dutton, T et al., (2012) [59] UK 48 Knee fractures Retransfusion drain No drain n/a Measure of transfusion rate Which patients benefit most from drains n/a 0% No follow up   No No 12.5
Sardar, Z et al., (2015) [60] Canada 24 Spinal fracture B2A peptide–enhanced ceramic granules (Prefix) Autogenous iliac crest bone graft (ICBG) n/a Radiographic Safety and efficacy Fusion rate 0% 6 wks, 3, 6, and 12 mo after surgery.   No No 14.5
Capa-Grasa, A et al., (2014) [61] Spain 40 Carpal Tunnel Ultra-MIS Mini-open Carpal Tunnel Release Quick-DASH questionnaire n/a Safety and efficacy Recruitment rates, compliance, completion, treatment blinding, personnel resources and sample size calculation 0% 3 mo Safety, sample size & cost Yes Yes 17
Okcu, G et al., (2013) [62] Turkey 40 Reverse obliquity fractures of the proximal femur Long nail implant Standard nail implant n/a Radiographic Reoperation (fixation failure), 1 year mortality rate, function and mobility & union rate Implant success 18% 12 to 20 mo   No No 16