NCT01756820.

Trial name or title	One‐portal endoscopic carpal tunnel release versus Knifelight for carpal tunnel syndrome. A randomised control trial (CTS‐HV)
Methods	Consecutive patients. Computer generated randomisation to be performed by an independent source contacted by phone upon the participant’s arrival (central randomisation). Randomisation will be performed per arm The participants will not be informed of their intervention (blinding of participants) An independent assessor will assess the outcomes (blinding of outcome assessors)
Participants	Estimated enrolment of 40 participants. Consecutive patients over 35 years old with electrophysiologically confirmed CTS will be included. Participants to have had at least 3 months of conventional treatment with no relief of symptoms. Secondary CTS, rheumatoid diseases, previous hand trauma will be excluded
Interventions	1‐portal ECTR (Microaire®) vs mini‐open Knifelight® (Stryker)
Outcomes	Outcomes will be assessed at 1 and 6 months postoperatively Primary outcomes Overall satisfaction, assessed in 2 ways: by answering the question "are you happy with the result of the surgery?" with a VAS score (0 to 100) assessing satisfaction Complications. Any complication will be reported including residual numbness, pain in incision, painful scar, complex regional pain syndrome, infection, etc Secondary outcomes Pain, assessed in 2 ways: as a dichotomous outcome (yes or no) as a continuous outcome (VAS score) Grip strength Key pinch Time to return to activities of daily living and return to work (for participants that are employed) Recurrences and reoperations Symptom Severity Scale (SSS) Functional Status Scale (FSS)
Starting date	January 2013
Contact information	Haris S Vasiliadis University of Ioannina, Greece vasiliadismd@gmail.com
Notes	Not yet recruiting

CTR: carpal tunnel release; CTS: carpal tunnel syndrome; ECTR: endoscopic carpal tunnel release; EMG: electromyography; OCTR: open carpal tunnel release; VAS: visual analogue scale