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A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release

S

Southern University of Science and Technology

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Procedure: a single-portal palm approach

Study type

Interventional

Funder types

Other

Identifiers

NCT05094778
ShenzhenPH Zhuang03

Details and patient eligibility

About

Traditional endoscopic release directly accesses the carpal tunnel and thus carries a higher risk of nerve irritability, even nerve injury. Based on our anatomical study, the investigators developed a new endoscopic technique through a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament. The investigators will compared the technique with the standard dual-portal endoscopic technique.

Full description

Conduct a multi-center, comparison clinical trial according to clinical Trial Reporting Standards (CONSORT). Patients in the single-portal group were treated with a single-portal palm approach that passes superficially to palmar aponeurosis and cut the full transverse carpal ligament. The comparison group were treated with Chow endoscopic technique. In order to assess efficiency of single-portal palm approach, the investigators will compared the technique with the standard dual-portal endoscopic technique. The study was approved by Shenzhen People's Hospital and informed consent was signed.

Enrollment

192 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A confirmed diagnosis of carpal tunnel syndrome based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand
  • Symptoms of carpal tunnel syndrome had lasted>2 months or inadequate responses to the non-surgical treatments≥3 months
  • moderate to severe symptoms.

Exclusion criteria

  • mild symptoms or prior injuries to the extremity
  • bilateral wrists involved, a combined nerve compression, gout, diabetes or chronic renal failure.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

192 participants in 1 patient group

single-portal group
Other group
Description:
The patients in single-portal group were treated with single-portal palm approach
Treatment:
Procedure: a single-portal palm approach

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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