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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simultaneous CTR | Active Comparator |
| |
| Postponed CTR) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Symptomatic Carpal Tunnel Syndrome | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Functional Status of the Upper Extremity. | 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).
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed Shibl Zaki, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University | Banhā | Al Qalyoubia | 13511 | Egypt |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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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.
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Both the investigators and the participants are aware of which arm the patient has been assigned to.
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| 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. |
|
| 5-10 weeks |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |