Treatment of Failed Carpal Tunnel Syndrome by Dorsal Ulnar Artery Perforator Adipofascial Flap

March 19, 2024 updated by: Mohamed Shehata Gaber, Sohag University

Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the general population. Surgical treatment by open or endoscopic carpal tunnel release (CTR) is the first choice of treatment and has clinical success rates of 75% to 90%.The rate of recurrence after primary median nerve release is 3-19% [1,2]. Between 0.3% and 12% of cases require surgical revision [2,3]. The risk factors for surgical revision for secondary release are male gender, staged or simultaneous bilateral carpal tunnel release, endoscopic release, smoking and rheumatoid arthritis.

Treatment failures after primary CTR are classified as persistent CTS, recurrent CTS, or new symptoms. Recurrent symptoms are uncommon and are defined by a symptom-free interval after surgery. Persistent symptoms are relatively common, particularly in elderly patients and in patients with concurrent nerve compression or medical conditions that affect nerve function, such as diabetes. Persistent or recurrent CTS principally results from incomplete release of the transverse carpal ligament but may be accompanied by perineural scarring, leading to compression or tethering of the median nerve.

New symptoms may be caused by iatrogenic nerve injury. Surgical treatment of recurrent or persistent CTS after primary CTR usually involves open revision CTR, extended proximally into unscarred tissue, and has also included internal or external neurolysis. Unsatisfactory results following revision CTR are common.

A second compression site, or double-crush syndrome, may clinically present as RCTS or PCTS . Thorough preoperative clinical examination may uncover signs of a second compression site, which can then be confirmed on electroneuromyography (ENMG) of the entire arm.

To improve outcomes of revision CTR, recent studies have emphasized the importance of median nerve coverage by well-vascularized soft tissue to enhance nerve healing, to prevent tethering in surrounding scar tissue, and to optimize nerve gliding in the carpal tunnel. Several local flaps (hypothenar fat pad flap, tenosynovial flap), regional flaps (posterior interosseous artery flap, reverse radial artery fascial flap, flexor digitorum superficialis flap), and free flap techniques have been described, but consensus for specific flap has not been reached. Following potential iatrogenic median nerve injury and reexploration for a painful neuroma incontinuity, flap coverage may also be beneficial.

In 1988, Becker and Gilbert introduced a Fasciocutaneous pedicled flap based on a consistent dorsal perforator of the ulnar artery (absent in 1 % of population) named the dorsal ulnar artery (DUA) flap or simply the Becker flap. The authors described open revision CTR with nerve coverage by a DUA flap in 3 patients with recurrent CTS and reported good results as well as a quick and easy-to-perform dissection with low donor site morbidity and preservation of the radial andulnar artery. Since this introduction, additional studies describing fasciocutaneous DUA flaps have mostly focused on its use for reconstruction of hand or wrist wounds. Despite the original described benefits, additional studies of DUA flaps for the treatment of recurrent or persistent CTS have remained limited.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Contact Backup

  • Name: Hassan H Noman, MD

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, Professor

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-60 years
  • Positive tinel sign
  • Operative interval more than 3 months & less than 2 years

Exclusion Criteria:

  • Cervical disc
  • Associated general disease (Rheumatoid arthritis, DM ,psychological problems & peripheral neuropathy)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain visual analogue scale (VAS)
Time Frame: 1 year
The visual analog scale for pain is a straight line with one end meaning no pain and the other end .meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".the position of the respondent's cross is generally assigned a score between 0 and 100. If documented in paper form, the scores can then be simply transferred to a 100-value scale using a millimeter tape measure
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two point discrimination test
Time Frame: 1 year
one of the most commonly used neurosensory tests to assess mechanoperception in the clinical settings. While there have been numerous studies of functional sensibility of the hand using TPD test.
1 year
Tinel sign
Time Frame: 1 year
a tingling or "pins and needles" feeling you get when your healthcare provider taps your skin over a nerve. Tinel's sign may be an indicator that you have nerve compression or damage where they're tapping
1 year

Collaborators and Investigators

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

Sponsor

Sohag University

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 (Actual)

March 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-24-02-06MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Failed Carpal Tunnel Syndrome Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe