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

Desai, Bijal; Desai, Veeral; Shah, Shivani; Srinath, Archita; Saleh, Amr; Simunovic, Nicole; Duong, Andrew; Sprague, Sheila; Bhandari, Mohit

doi:10.1186/s12891-018-2337-7

BMC Musculoskeletal Disorders

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

Back to article page

ISSN: 1471-2474

Contact us

Submission enquiries: bmcmusculoskeletaldisorders@biomedcentral.com
General enquiries: ORSupport@springernature.com