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

The Second Hospital of Qinhuangdao

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Procedure: Carpal Tunnel Release via limited approaches; Procedure: Endoscopic Carpal Tunnel Release; Device: endoscope or an arthroscopic device; Procedure: Carpal Tunnel Release via standard approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02500355

qhd20150712

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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220 participants in 3 patient groups, including a placebo group

Group A

Active Comparator group

Description:

Carpal Tunnel Release via limited approaches with 2 years follow-up.

Treatment:

Procedure: Carpal Tunnel Release via limited approaches

Group B

Active Comparator group

Description:

Carpal Tunnel Release via standard approach with 2 years follow-up.

Treatment:

Procedure: Carpal Tunnel Release via standard approach

Group C

Placebo Comparator group

Description:

Endoscopic Carpal Tunnel Release with 2 years follow-up.

Treatment:

Device: endoscope or an arthroscopic device

Procedure: Endoscopic Carpal Tunnel Release