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

NCT ID: NCT05094778

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-05

Study Completion Date

2021-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome

Keywords

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Carpal tunnel syndrome carpal tunnel release pain nerve compression syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single-portal group

The patients in single-portal group were treated with single-portal palm approach

Group Type OTHER

a single-portal palm approach

Intervention Type PROCEDURE

a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament.

Interventions

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a single-portal palm approach

a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University Third Hospital

OTHER

Sponsor Role collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yongqing Zhuang

Role: PRINCIPAL_INVESTIGATOR

Shenzhen People's Hospital

References

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Shi Q, Bobos P, Lalone EA, Warren L, MacDermid JC. Comparison of the Short-Term and Long-Term Effects of Surgery and Nonsurgical Intervention in Treating Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis. Hand (N Y). 2020 Jan;15(1):13-22. doi: 10.1177/1558944718787892. Epub 2018 Jul 17.

Reference Type RESULT
PMID: 30015499 (View on PubMed)

Wei R, Chen C, Liu Y, Liu Z, Xiong H, Zhang X, Zhuang Y. Endoscopic Release Superficial Rather Than Deep to the Transverse Carpal Ligament for Carpal Tunnel Syndrome Improves Immediate Postoperative Transient Symptomatic Exacerbation With Fewer Absences From Work. Arthroscopy. 2023 Apr;39(4):963-970.e2. doi: 10.1016/j.arthro.2022.09.013. Epub 2022 Oct 5.

Reference Type DERIVED
PMID: 36208712 (View on PubMed)

Other Identifiers

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ShenzhenPH Zhuang03

Identifier Type: -

Identifier Source: org_study_id