Single-portal Endoscopic Carpal Tunnel Release Versus Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial

Phase 2

Withdrawn

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Single-portal Endoscopic Carpal Tunnel Release (Microaire®); Procedure: Knifelight

• Registration Number: NCT01756820
• Lead Sponsor: University of Ioannina

Brief Summary

The purpose of this study is to determine whether Single-portal Endoscopic Carpal Tunnel Release (Agee technique, SmartRelease™, MicroAire) and mini-open technique (Knifelight®, Stryker) are equally effective and safe surgical options for the treatment of primary Carpal Tunnel Syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-26
• Study First Posted: 2012-12-27
• Study Start: 2013-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• primary Carpal Tunnel Syndrome

• no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)

  • electrophysiological examination confirms the Carpal Tunnel Syndrome

Exclusion Criteria

• Secondary Carpal Tunnel Syndrome
• Pregnancy
• Rheumatoid diseases
• Previous trauma at hand or other condition that may effect the anatomy (eg infections)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-portal Endoscopic Carpal Tunnel Release (Microaire®)	Single-portal Endoscopic Carpal Tunnel Release (Microaire®)	Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al.
Knifelight®	Knifelight	A mini-open technique will be performed, using the Knifelight® (Stryker).

Primary Outcome Measures

Name	Time	Method
Overall Satisfaction	at 1 and 6 months postoperatively	Satisfaction will be assessed by two ways; * by answering to the question "are you happy with the result of the surgery?"; * with a VAS score (0-100) assessing the satisfaction
Complications	up to 6 months postoperatively	Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc

Secondary Outcome Measures

Name	Time	Method
Pain	at 1 and 6 months postoperatively	Pain will be assessed; * as a dichotomous outcome (yes/no); * as a continuous outcome (VAS score)
Grip strength	at 1 and 6 months postoperatively
key pinch	at 1 and 6 months postoperatively
Time to return to Activities of Daily Living (ADL) and return to work	up to the end of the study	Time to return to Activities of Daily Living (ADL) will be reported. Return to work will also be reported for participants that are employed.
Recurrences and reoperations	up to the end of study
Symptom Severity Scale (SSS)	at 1 and 6 months postoperatively
Function Severity Status (FSS)	at 1 and 6 months postoperatively

Trial Locations

Locations (1)

University Hospital of Ioannina; 🇬🇷 Ioannina, Greece