Carpal Tunnel Syndrome
Conditions
Keywords
Carpal Tunnel Syndrome, transverse ligament, carpal tunnel release, endoscopic, minimal invasive, mini-open, median nerve
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.
Interventions
PROCEDURESingle-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/).
PROCEDUREKnifelight
A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)
Sponsors
University of Ioannina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Pain | at 1 and 6 months postoperatively | Pain will be assessed * as a dichotomous outcome (yes/no) * as a continuous outcome (VAS score) |
| Symptom Severity Scale (SSS) | at 1 and 6 months postoperatively | — |
| Function Severity Status (FSS) | at 1 and 6 months postoperatively | — |
| Recurrences and reoperations | up to the end of study | — |
| Grip strength | at 1 and 6 months postoperatively | — |
Countries
Greece
Outcome results
None listed