Simultaneous vs. Postponed Carpal Tunnel Release (CTR) During Distal Radius Fracture (DRF) Fixation.

March 29, 2026 updated by: Adel Samy ElHammady, Benha University

Cons and Pros of Concomitant Carpal Tunnel Release During Distal Radius Fracture Fixation

This randomized study evaluates the impact of performing a prophylactic carpal tunnel release (CTR) at the same time as surgical fixation for a distal radius fracture (DRF). The study compares this simultaneous approach against a postponed approach (observing and only performing CTR if symptoms develop) to determine which strategy better reduces the frequency of re-operation and improves functional outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

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

  • Egypt
    • Al Qalyoubia
      • Banhā, Al Qalyoubia, Egypt, 13511
        • Benha University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients presenting with trauma to the lower end of the radius requiring surgical intervention.
  • Fractures classified as AO/OTA classes involving significant displacement, articular surface depression, or comminution (excluding simple A-C1 classes).

Exclusion Criteria:

  • Simple fractures (AO/OTA class A-C1) suitable for non-operative management.
  • Pre-existing neurocognitive or psychological disorders.
  • Refusal to participate or sign written consent.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Simultaneous CTR
Procedure: Carpal tunnel release
During the internal fixation of the fracture via the Henry approach, the incision is extended distally into the palm. The transverse carpal ligament is incised to decompress the median nerve at the same time the bone is fixed.
Procedure: Distal Radius Fracture Fixation with Observation.
Standard operative procedure for the fracture fixation only. Patients are monitored during follow-up; those who subsequently develop median nerve compression symptoms are then prepared for an elective CTR in a separate surgical setting.
Active Comparator: Postponed CTR)
Procedure: Distal Radius Fracture Fixation with Observation.
Standard operative procedure for the fracture fixation only. Patients are monitored during follow-up; those who subsequently develop median nerve compression symptoms are then prepared for an elective CTR in a separate surgical setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Symptomatic Carpal Tunnel Syndrome
Time Frame: From surgery through the completion of fracture healing (4-6 wks)
The number of patients who develop symptomatic median nerve compression requiring medical or surgical intervention after the initial fracture correction.
From surgery through the completion of fracture healing (4-6 wks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Functional Status of the Upper Extremity.
Time Frame: 5-10 weeks

This tool uses 11 items to measure the degree of difficulty a patient has performing specific physical activities (6 items) and the impact of symptoms like pain and numbness on social activities, work, and sleep (5 items).

  • Each item is scored on a 5-point Likert scale.
  • The total score is transformed into a percentage (0-100%), where a higher percentage indicates more severe disability and greater difficulty in daily functioning.
5-10 weeks

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: Mohammed Shibl Zaki, MD

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)

February 25, 2023

Primary Completion (Actual)

August 21, 2025

Study Completion (Actual)

February 15, 2026

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC:4.12.2022

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.

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