Carpal Tunnel Syndrome (CTS)
Conditions
Brief summary
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.
Interventions
PROCEDURECarpal 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.
PROCEDUREDistal 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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Both the investigators and the participants are aware of which arm the patient has been assigned to.
Intervention model description
Participants are assigned to one of two distinct groups (arms) simultaneously. Each group follows a specific protocol throughout the study duration to allow for a direct head-to-head comparison of outcomes.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Symptomatic Carpal Tunnel Syndrome | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Functional Status of the Upper Extremity. | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohammed Shibl Zaki, MD
Outcome results
None listed