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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