Pronator Quadratus Preservation Following Volar Plate Fixation. RCT

Study Overview
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Brief Summary
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The purpose of this study is to determine pronator quadrutus preservation have clinical impact following volar plate fixation

Official Title
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Preservation vs (Repair or Not Repair) Pronator Quadratus in the Volar Plating of Distal Radial Fracture. Randomized Controlled Clinical Trial

Conditions
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Wrist Fracture,, Distal Radius Fracture, Pronator Quadratus, Volar Plate, Surgery

Intervention / Treatment
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* Procedure: Pronator quadratus preservation after volar plate fixation in wrist fractures
* Procedure: Pronator quadratus repair after volar plate fixation in wrist fractures
* Procedure: Pronator quadratus nonrepair after volar plate fixation in wrist fractures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fractures of distal radius with instability (Aofoundation.org) Age between 15-75 años Informed consent approval for ethical comitte Exclusion Criteria: Previos surgery of the hand, wrist or forearm Inflammatory arthropathy Carpal tunel syndrome Sensory or mixed neuropathy Bilater wrist fracture Functional deficits of ipsilateral extremity Functional deficits of contralateral extremity Complications after surgery with motor deficit Disease that can evolve with neuropathy during study time

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pronator quadratus preservation<br>Pronator quadratus preservation | Procedure: Pronator quadratus preservation after volar plate fixation in wrist fractures<br>* Pronator quadratus preservation after volar plate fixation in wrist fractures<br>|
| Active Comparator: Pronator quadratus non repair<br> | Procedure: Pronator quadratus nonrepair after volar plate fixation in wrist fractures<br>* Pronator quadratus nonrepair after volar plate fixation in wrist fractures<br>|
| Active Comparator: Pronator quadratus repair after disruption<br> | Procedure: Pronator quadratus repair after volar plate fixation in wrist fractures<br>* Pronator quadratus repair after volar plate fixation in wrist fractures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical impact in dairy life | Clinical impact in dairy life with a functional score | Up to 12 month | 
| Pronosupination strength | Pronosupination strength | Up to 12 month | 
| Proprioception | Proprioception | Up to 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proprioception evolution after surgery | Proprioception evolution after surgery | Up to 12 month | 
| Flexor tendon rupture |  | Up to 12 month | 
| Infection after surgery | Infection after surgery | Up to 12 month | 
| Ischaemic time surgery | ischaemic time surgery | Up to 12 month | 
| Pronosupination strenght evolution |  | Up to 12 month |