Table 2 Characteristics of Included Definitive trials
From: Pilot randomized controlled trials in the orthopaedic surgery literature: a systematic review
Pilot RCT Author | Definitive RCT Author | Country of Publication | Number. Of Patients | Change in Condition/Intervention | Primary Outcomes | Secondary Outcomes | Loss to Follow up (%) | Were Pilot Patients rolled into the definitive sample size? | Was the sample size calculation based on data from the pilot? | Number of months between publication of pilot trial and definitive trial | CLEAR NPT score: |
|---|---|---|---|---|---|---|---|---|---|---|---|
Buse G. et al. (2014) [27] | Manach, Y. L. et al.,(ongoing) [63] | Canada | 1200 (still recruiting) | No change | Major perioperative complication | Mortality, myocardial infarction, cardiac revascularization procedure | 0.00 | Unclear | Yes | 68 (projeted end date July 2018) | 18 |
Hamdy, R. C. et al. (2009) [15] | Hamdy, R. C. et al. (2016) [64] | Canada | 125 | No change | Quality of life (questionaires, filled out by parents and children) 4 PedsQL scales. | n/a | 4.00 | Unclear | No | 78 | 18 |
Flow Investigators (2011) [38] | Bhandari M. et al. (2015) [65] | Canada | 2551 | No change | Reoperation, to treat an infection at the operative site or contiguous to it, manage a wound-healing problem or promote bone healing. | n/a | 0.00 | No | No | 51 | 18 |
Costa, M. et al. (2003) [40] | Costa, M. et al. (2006) [66] | UK | 48 | No change | Time taken to return to normal activities, as reported by the patient | Complication rate in the treatment group | 10.40 | No | Yes | 26 | 18 |
Capa-Grasa. et al. (2014) [61] | Rojo-Manaute, J. et al. (2016) [67] | Spain | 92 | No change | To compare the clinical outcomes of two surgical outcomes with primary carpal tunnel syndrome. | n/a | 0.00 | No | Yes | 4 | 18 |