Effectiveness of Immobilization in the Postoperative Analgesia of Surgically Treated Distal Radius Fractures

Study Overview
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Brief Summary
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The purpose of this study is to determine wether postoperative immobilization is effective in controlling the pain of patients with intra-articular distal radius fractures treated with volar locking plate fixation. The study hypotheses is that postoperative immobilization does not enhance the analgesia of these patients.

Detailed Description
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Volar locking plate fixation has been used as the gold standard treatment for intra-articular distal radius fractures. The need for postoperative immobilization after this type of fixation is controversial, with some authors advocating its use for analgesia. Conversely, the use of immobilization might retard the recovery of wrist range of motion and function. The objective of this study is to compare the level of pain and function of patients undergoing surgical fixation of distal radius fractures using or not postoperative immobilization. Patients will be randomly assigned to receive a plaster splint or conventional dressing immediately after the surgery. The main outcome is the level of pain in the first two weeks postoperatively.

Official Title
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Effectiveness of Immobilization in the Postoperative Analgesia of Patients With Distal Radius Fracture Treated With Volar Locking Plating: a Prospective, Randomized Clinical Trial

Conditions
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Radius Fracture Distal

Intervention / Treatment
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* Procedure: No immobilization
* Procedure: Volar splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intra-articular distal radius fracture treated with volar locking plate fixation; Fracture occurred within the prior 30 days; Consent to participate in the study Exclusion Criteria: Concomitant fracture of the ipsilateral upper limb Previous lesion of the ipsilateral upper limb with functional deficit Bilateral fracture Concomitant neurologic injury Patient not amenable to follow-up

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No immobilization<br>Patients receive a conventional dressing made with gauze, cotton padding and inelastic bandage after the surgery. They are instructed to start light wrist movements on the first postoperative day and progress as tolerated, beginning rehabilitation with physiotherapy after 2 weeks postoperatively. | Procedure: No immobilization<br>* Conventional wrist dressing<br>|
| Active Comparator: Volar splint<br>Patients receive a volar plaster splint with inelastic bandage after the surgery, and are instructed not to remove the immobilization for 2 weeks. After this period, the immobilization is removed and patients begin rehabilitation with physiotherapy. | Procedure: Volar splint<br>* Volar plaster splint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain | Visual analogue scale for pain | 12 hours | 
| Level of pain | Visual analogue scale for pain | 18 hours | 
| Level of pain | Visual analogue scale for pain | 24 hours | 
| Level of pain | Visual analogue scale for pain | Once a day in the first week | 
| Level of pain | Visual analogue scale for pain | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain | Visual analogue scale for pain | 6 weeks | 
| Level of pain | Visual analogue scale for pain | 3 months | 
| Level of pain | Visual analogue scale for pain | 6 months | 
| DASH score | Disabilities of the Arm, Shoulder and Hand (DASH) | 6 weeks | 
| DASH score | Disabilities of the Arm, Shoulder and Hand (DASH) | 3 months | 
| DASH score | Disabilities of the Arm, Shoulder and Hand (DASH) | 6 months | 
| Wrist flexion-extension arc | Assessed by goniometry | 2 weeks | 
| Wrist flexion-extension arc | Assessed by goniometry | 6 weeks | 
| Wrist flexion-extension arc | Assessed by goniometry | 3 months | 
| Wrist flexion-extension arc | Assessed by goniometry | 6 months | 
| Forearm rotation arc | Assessed by goniometry | 2 weeks | 
| Forearm rotation arc | Assessed by goniometry | 6 weeks | 
| Forearm rotation arc | Assessed by goniometry | 3 months | 
| Forearm rotation arc | Assessed by goniometry | 6 months | 
| Tramadol use | Percentage of patients requesting additional analgesia with tramadol in the first week | Once a day in the first week post-op | 
| Complication | Percentage of patients presenting with any type of local orthopedic complication | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal radius fracture, volar plate, immobilization