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The principal investigator of the study relocated to another institution.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-portal Endoscopic Carpal Tunnel Release (Microaire®) | Active Comparator | Single-portal Endoscopic Carpal Tunnel Release (Microaire®) will be used, according to the endoscopic technique described by Agee at al. |
|
| Knifelight® | Active Comparator | A mini-open technique will be performed, using the Knifelight® (Stryker). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-portal Endoscopic Carpal Tunnel Release (Microaire®) | Procedure | SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Satisfaction | Satisfaction will be assessed by two ways
| at 1 and 6 months postoperatively |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain will be assessed
| at 1 and 6 months postoperatively |
| Grip strength | at 1 and 6 months postoperatively |
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Inclusion Criteria:
primary Carpal Tunnel Syndrome
no symptoms' relief after 3 months of conservative treatment (NSAIDS, Cast, rest)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haris S Vasiliadis, MD, PhD | Department of Orthopaedics, School of Medicine, University of Ioannina, Greece | Principal Investigator |
| Theodoros Xenakis | Department of Orthopaedics, School of Medicine, University of Ioannina, Greece | Study Chair |
| Grigorios Mitsionis | Department of Orthopaedics, School of Medicine, University of Ioannina, Greece | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Ioannina | Ioannina | 45500 | Greece |
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| Knifelight | Procedure | A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach) |
|
|
| key pinch | at 1 and 6 months postoperatively |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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