Single-portal Endoscopic Carpal Tunnel Release vs Knifelight for Carpal Tunnel Syndrome. A Randomized Control Trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- University of Ioannina
- 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
Haris S Vasiliadis, MD, PhD
Lecturer in Orthopaedics
University of Ioannina