- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07434999
Tendon Transfer for Correction of Pinch in Chronic Ulnar Nerve Injury
February 24, 2026 updated by: Mostafa Elsayed Mohamed, Sohag University
Evaluation of Combined ECRB and APL Tendon Transfer for Pinch Restoration in Chronic Ulnar Nerve Injury
This prospective study evaluates the outcomes of combined ECRB and APL tendon transfer for restoring pinch function in patients with chronic ulnar nerve injury.
Patients will be followed postoperatively to assess improvement in hand function, strength, and daily activity performance.
Participation is voluntary and all standard care procedures will be maintained
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The study is a prospective, single-center interventional trial including adult patients diagnosed with chronic ulnar nerve injury affecting pinch function.
Eligible participants will undergo combined ECRB (Extensor Carpi Radialis Brevis) tendon transfer to adductor pollicis tendon and APL (Abductor Pollicis Longus) tendon transfer to 1st dorsal interosseous tendon that performed by experienced surgeons.
Preoperative evaluation includes baseline hand function, pinch strength, and disability assessment.
Postoperative follow-up will occur at 4, 6, 12, and 24 weeks to measure functional improvement using standardized hand assessment tools.
Adverse events will be monitored and recorded.
Inclusion criteria: adults ≥18 years, chronic ulnar nerve injury >6 months, and consent to participate.
Exclusion criteria: prior tendon transfer, coexisting neuromuscular disorder, or inability to provide consent.
Data will be anonymized to maintain confidentiality, and all ethical approvals will be in place.
Study Type
Interventional
Enrollment (Estimated)
17
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
-
-
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Sohag, Egypt
- SohagUniversity
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-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with chronic ulnar nerve injury (more than 1 year duration).
- Age between 18 and 60 years.
- Patients with stable joints and good passive range of motion of the hand and fingers.
- Absence of active infection or severe contracture.
Exclusion Criteria:
• Patients with combined median or radial nerve injury.
- Patients with severe soft-tissue loss or fixed deformities precluding tendon transfer.
- Uncooperative patients or those with systemic diseases affecting muscle power or healing (e.g., diabetes mellitus, peripheral vascular disease).
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ECRB and APL Tendon Transfer
ECRB transfer transfer to adductor pollicis and APL tendon transfer to 1st dorsal interosseous muscle for pinch restoration in chronic ulnar nerve injury
|
This surgical procedure involves transferring the Extensor Carpi Radialis Brevis (ECRB) and Abductor Pollicis Longus (APL) tendons to restore pinch function in patients with chronic ulnar nerve injury.
Standard postoperative physiotherapy will follow, with assessments at 4, 6, and 12 weeks to monitor pinch strength, thumb mobility, and any complications
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Grip Strength of the Operated Hand Measured Using a Hand Dynamometer (kg)
Time Frame: 6 months postoperatively
|
Grip strength of the operated hand will be assessed using a calibrated hand dynamometer.
Three consecutive measurements will be obtained during the same session, and the average value will be calculated and reported in kilograms.
|
6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DASH Score (Disabilities of the Arm, Shoulder and Hand Questionnaire)
Time Frame: 3 months postoperatively
|
Functional outcome will be assessed using the DASH questionnaire.
The total score ranges from 0 to 100, with higher scores indicating greater disability.
The overall total score will be reported.
|
3 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mostafa Elsayed, Sohag University
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)
November 18, 2025
Primary Completion (Actual)
December 20, 2025
Study Completion (Estimated)
December 20, 2026
Study Registration Dates
First Submitted
February 19, 2026
First Submitted That Met QC Criteria
February 24, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 24, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Soh_Med_26_2_5MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be made publicly available.
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.