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

Carpal Tunnel Syndrome Clinical Trial

— CTS-HV  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01756820
• Other study ID #: Ioannina-CTS-HV
• Status: Withdrawn
• Phase: Phase 2
• First received: December 20, 2012
• Last updated: May 10, 2016
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Single-portal Endoscopic Carpal Tunnel Release (Microaire®)
SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/).
• Knifelight
A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)

Locations

Country	Name	City	State
Greece	University Hospital of Ioannina	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Satisfaction	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	at 1 and 6 months postoperatively	No
Primary	Complications	Any complication will be reported including remaining numbness, pain in incision, painful scar, complex regional pain syndrome, infection etc	up to 6 months postoperatively	Yes
Secondary	Pain	Pain will be assessed; as a dichotomous outcome (yes/no); as a continuous outcome (VAS score)	at 1 and 6 months postoperatively	No
Secondary	Grip strength		at 1 and 6 months postoperatively	No
Secondary	key pinch		at 1 and 6 months postoperatively	No
Secondary	Time to return to Activities of Daily Living (ADL) and return to work	Time to return to Activities of Daily Living (ADL) will be reported. Return to work will also be reported for participants that are employed.	up to the end of the study	No
Secondary	Recurrences and reoperations		up to the end of study	Yes
Secondary	Symptom Severity Scale (SSS)		at 1 and 6 months postoperatively	No
Secondary	Function Severity Status (FSS)		at 1 and 6 months postoperatively	No