- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07393061
Partial Wrist Denervation in Comminuted Articular Distal Radius Fractures
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Distal radius fractures represent the most common fractures in adults showing an overall prevalence of 17.5 % with respect to all fractures. partial wrist denervation is an adjunctive procedure performed during initial fracture fixation to mitigate chronic pain by interrupting sensory innervation to the wrist joint. It targets the anterior interosseous nerve (AIN) and posterior interosseous nerve (PIN), which convey nociceptive signals from the radiocarpal and midcarpal joints.
Comminuted intra-articular distal radius fractures (AO/OTA Type C2/C3) often lead to post-traumatic arthritis due to articular incongruity and capsular damage. Denervation at the index procedure may reduce central sensitization and chronic pain by resecting afferent pain fibers, potentially improving postoperative rehabilitation and functional outcomes.
Acute comminuted intra-articular distal radius fractures (AO/OTA C2/C3) with high risk of post-traumatic arthritis (e.g., articular step-off >2 mm, severe fragmentation).
- Active individuals seeking motion preservation, those with high functional demands (e.g., athletes, laborers), or patients preferring a less invasive option than salvage procedures.
- Adjunct to primary fixation: Performed concurrently with volar locking plate (VLP) or dorsal plating.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Asyut, Egypt, 22222
- Assiut Universty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:• Age from 18
- Fracture Pattern: Acute, comminuted intra-articular distal radius fractures (AO/OTA Type C2 or C3).
- Surgical Context: Procedure performed as a primary adjunct during initial open reduction and internal fixation (ORIF).
Exclusion Criteria:Active local infection over the surgical site.
- Compromised soft tissue envelope that precludes safe dissection.
- Vascular injury or compromise requiring repair.
- Pre-existing neurological deficit (e.g., complex regional pain syndrome, major peripheral nerve injury).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: parital wrist denervation
Partial Wrist Denervation in Comminuted articular Distal Radius Fractures
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Partial Wrist Denervation in Comminuted articular Distal Radius Fractures through sme approach of the surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The end results PAIN will be assessed according to mayo clinc wrist score
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months..and 1 year
|
mayo clinc wrist score its a clincal reported outcome measure designed to assess function and pain of the wrist follwing surgery the score is bassed on 100 points divided into four equally weighted categories the final score places the wrist into outcome category total score 90/100 is excellent while below 65 is poor
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2 weeks, 6 weeks, 3 months, 6 months..and 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: walyd ryad saleh, professor of orthopedics, Assiut University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- denervation in fracture radius
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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