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

July 15, 2015 updated by: The Second Hospital of Qinhuangdao

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Qinhuangdao, Hebei, China, 066600
        • The Second Hospital of Qinhuangdao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of symptoms and functional status on Boston Questionnaire
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Grip strength
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Qinhuangdao

Investigators

  • Study Chair: Xu Zhang, MD, The Second Hospital of Qinhunangdao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 12, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qhd20150712

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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