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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: 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

• Registration Number: NCT02500355
• Lead Sponsor: The Second Hospital of Qinhuangdao

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2015-07
• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-16
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Carpal Tunnel Release via limited approaches	Carpal Tunnel Release via limited approaches with 2 years follow-up.
Group C	endoscope or an arthroscopic device	Endoscopic Carpal Tunnel Release with 2 years follow-up.
Group B	Carpal Tunnel Release via standard approach	Carpal Tunnel Release via standard approach with 2 years follow-up.
Group C	Endoscopic Carpal Tunnel Release	Endoscopic Carpal Tunnel Release with 2 years follow-up.

Primary Outcome Measures

Name	Time	Method
Severity of symptoms and functional status on Boston Questionnaire	2 years

Secondary Outcome Measures

Name	Time	Method
Grip strength	2 years

Trial Locations

Locations (1)

The second hospital of Qinhuangdao; 🇨🇳 Qinhuangdao, Hebei, China