Table 1.
Characteristics of the Included Pilot RCTs
| 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 |