Carpal Tunnel Release Via Two Small Incisions Comparing With Via Standard Incision And Under Endoscope

Study Overview
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Brief Summary
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Carpal Tunnel Release via Two Small Incisions Comparing With via Standard Incision And Under Endoscope.

Detailed Description
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Carpal tunnel syndrome (CTS) affects over 60 million people worldwide. If a regimen of conservative management has failed, surgical release of the median nerve is warranted. Numerous approaches for carpal tunnel release have been described that range from an open technique to a limited incision to endoscopic release. In addition, partial excision of the flexor retinaculum is advocated by some surgeons because of obtaining better outcomes. However, the procedure is difficult to be accomplished through small incisions owing to poor visualization. Currently, balance of incision, visualization, and partial excision of the flexor retinaculum is still controversial. The objective of this report is to introduce carpal tunnel release with partial excision of the flexor retinaculum through two small incisions. The procedures were performed under lighted head magnifier. This is the first report on the use of our technique. For comparison, the investigators also included two other groups of standard open carpal tunnel release with partial excision of the flexor retinaculum and endoscopic carpal tunnel release without excision of the flexor retinaculum.

Official Title
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Carpal Tunnel Release With Partial Excision of the Flexor Retinaculum Through Two Small Incisions

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Carpal Tunnel Release via limited approaches
* Procedure: Carpal Tunnel Release via standard approach
* Procedure: Endoscopic Carpal Tunnel Release
* Device: endoscope or an arthroscopic device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of CTR was established based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand (2003) Patients with moderate, severe, and very severe symptom. Exclusion Criteria: Mild symptom. Finding had a ganglion based on preoperative ultrasound. Associated with infection, gout, or diabetes. Patients who discontinued intervention and lost to follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Carpal Tunnel Release via limited approaches with 2 years follow-up. | Procedure: Carpal Tunnel Release via limited approaches<br>* Carpal tunnel release with partial excision of the flexor retinaculum via two small incisions.<br>|
| Active Comparator: Group B<br>Carpal Tunnel Release via standard approach with 2 years follow-up. | Procedure: Carpal Tunnel Release via standard approach<br>* Carpal tunnel release with partial excision of the flexor retinaculum via the standard incision.<br>|
| Placebo Comparator: Group C<br>Endoscopic Carpal Tunnel Release with 2 years follow-up. | Procedure: Endoscopic Carpal Tunnel Release<br>* Carpal tunnel release under endoscope.<br>Device: endoscope or an arthroscopic device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of symptoms and functional status on Boston Questionnaire |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength |  | 2 years |