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Completed

NCT Number: NCT07509437

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

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Al Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carpal tunnel release

Procedure

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.

Distal Radius Fracture Fixation with Observation.

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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