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Clinical Trials/NCT01756820
NCT01756820WithdrawnPhase 2

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

University of Ioannina2 sites in 1 countryStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Locations
2
Primary Endpoint
Overall Satisfaction

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
35 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Overall Satisfaction

Time Frame: 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

Time Frame: 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 Outcomes

  • Symptom Severity Scale (SSS)(at 1 and 6 months postoperatively)
  • Function Severity Status (FSS)(at 1 and 6 months postoperatively)
  • Pain(at 1 and 6 months postoperatively)
  • 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)
  • Recurrences and reoperations(up to the end of study)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Haris S Vasiliadis, MD, PhD

Lecturer in Orthopaedics

University of Ioannina

Study Sites (2)

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