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No randomized trials have compared long-term outcomes following endoscopic and open carpal tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a single-center randomized controlled trial between January 1998 and December 2002, including 128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed idiopathic CTS. The outcome measures included the validated CTS symptom severity and functional status scales completed at baseline and 1 year postoperatively. The trial showed that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and function were equivalent. This extended follow-up of the randomized trial will primarily measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by mail to the patients. The questionnaire will consist of the CTS symptom severity and functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog scale about treatment satisfaction. The patients will also be asked about whether they had undergone further surgery for CTS in the same or contralateral hand after their operation in the randomized trial. The completed questionnaires will be scanned into a database. The scores for the different scales will be calculated. Analysis will include comparison between the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open surgery | Active Comparator | Open surgery is Open carpal tunnel release |
|
| Endoscopic surgery | Experimental | Endoscopic surgery is 2-portal endoscopic carpal tunnel release |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic surgery | Procedure | Surgery dwas done under local anesthesia injected at the portal sites only. Tourniquet was used. Each of the two skin incisions in the endoscopic procedure was 1 cm long. With the endoscope inserted from the distal portal and a hook knife inserted from the proximal portal, the transverse carpal ligament was divided from its distal edge to its proximal edge. Incisions were closed with non-absorbables sutures and a soft dressing was applied. Sutures were removed 10 days postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CTS symptom severity score | Baseline to 10-15 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of repeat surgery | 10-15 years postoperatively | |
| Change in CTS functional status score | from baseline and 1 year to 10-15 years postoperatively | |
| Residual pain in the scar or proximal palm |
| Measure | Description | Time Frame |
|---|---|---|
| CTS-6 score | 10-15 years postoperatively | |
| QuickDASH score | 10-15 years postoperatively |
Inclusion Criteria (original trial):
Exclusion Criteria (original trial):
Inflammatory joint disease
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| Name | Affiliation | Role |
|---|---|---|
| Isam Atroshi, MD, PhD | Clinical Sciences, Lund University, Sweden | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16777857 | Background | Atroshi I, Larsson GU, Ornstein E, Hofer M, Johnsson R, Ranstam J. Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial. BMJ. 2006 Jun 24;332(7556):1473. doi: 10.1136/bmj.38863.632789.1F. Epub 2006 Jun 15. | |
| 26441187 | Derived |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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|
|
| Open surgery | Procedure | Open carpal tunnel release using conventional open technique under local anesthesia and tourniquet. The incision in the open procedure extended from about 1 cm proximal to 3 cm distal to the wrist crease. The transverse carpal ligament was divided; no additional procedures were performed. a soft dressing was applied. Dressing and sutures were removed 10 days postoperatively. |
|
|
| 10-15 years postoperatively |
| Patient satisfaction with the results of surgery | 10-15 years postoperatively |
| Change in CTS symptom severity score | 1 year to 10-15 years postoperatively |
| Atroshi I, Hofer M, Larsson GU, Ranstam J. Extended Follow-up of a Randomized Clinical Trial of Open vs Endoscopic Release Surgery for Carpal Tunnel Syndrome. JAMA. 2015 Oct 6;314(13):1399-401. doi: 10.1001/jama.2015.12208. No abstract available. |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D013514 | Surgical Procedures, Operative |