Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

Study Overview
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Brief Summary
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The aim of this study is to compare functional and radiological results in two groups of distal radius fractures treated with internal fixation with locking plate, and immobilized with antebrachial splint or compression bandage for 3 weeks.

Detailed Description
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The aim of the study is to compare functional and radiological results as well as to evaluate possible complications in distal radius fractures operated by open reduction and internal fixation with volar locking plate in two groups , one treated with immobilization using a forearm cast for 3 weeks and the other with immobilization using a compression bandage for 3 weeks, based on the hypothesis that compression bandage group could obtain better results in the short term, and none of the treatments is superior to the other after 3 or 6 months of evolution, as indicated by some reviewed studies.

Official Title
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Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures Operated by Internal Fixation With Volar Locking Plate: A Pilot Study

Conditions
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Distal Radius Fractures, Internal Fixation; Complications, Mechanical

Intervention / Treatment
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* Device: Splint inmmobilization
* Device: Bandage immovilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type A, B, C fractures of AO classification of distal radius fractures Patents aged between 18 and 75 years, Patients operated on in the first 3 weeks after the trauma, and independent for the basic activities of daily living Exclusion Criteria: Patients with open fractures Patients with mental disorders (dementia, alcoholism, etc.), Patient dependent for basic activities of daily living Patients with fractures with severe articular and metaphyseal comminution and/or severe soft tissue injuries (type 2R3C3 AO), Patients with previous diseases or anatomical alterations in the injured wrist (previous fractures, rheumatoid arthritis, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: 2 parallel groups, each one receives one treatment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Splint inmmobilization<br>Distal radius fractures fixed with volar locking plate and immobilized with an antebrachial splint for 3 weeks | Device: Splint inmmobilization<br>* After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with a plaster splint of París for 3 weeks<br>|
| Active Comparator: Bandage immovilization<br>Distal radius fractures fixed with volar locking plate and immobilized with a compressive bandage for 3 weeks | Device: Bandage immovilization<br>* After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in Visual Analogue Scale. | Points from 1 to 10. Higher score: worse value. Lower score: better value. | 1 year | 
| Function in Patient Rated Wrist Evaluation Scale. | Points from 1 to 100. Higher score: worse value. Lower score: better value. | 1 year | 
| Range Of Motion in Flexion. | Grades from 0 to 70. Higher score: better value. Lower score: worse value. | 1 year | 
| Range Of Motion in Flexion. | Grades from 0 to 80. Higher score: better value. Lower score: worse value. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function in Disabilities of Arm, Shoulder and Hand Scale. | Points from 1 to 150. Higher score: worse value. Lower score: better value | 1 year | 
| Function in Mayo Wrist Score Scale. | Points from 1 to 100. Higher score: worse value. Lower score: better value. | 1 year | 
| Range of motion in Supination. | Grades from 0 to 90. Higher score: better value. Lower score: worse value. | 1 year | 
| Number of participants with posoperative complications. | Number of participants per group that suffer some complication or side effect during the follow-up period. Higher number of complications: worse value. | 1 year | 
| Number of posoperative Fisiotherapy sessions performed. | Number of sessions per participant from 1 to 100. Higher score: worse value. Lower score: better value. | 1 year | 
| Time of fracture union in radiographs. | Number of Weeks from 1 to 12. Higher score: worse value. Lower score: better value. | 12 weeks | 
| Number of Instability distal radius fracture Criteria per participant. | Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value. | 1 year | 
| Grades of Dorsal Displacement in fracture. | Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value. | 6 weeks | 
| Range of motion in Pronation. | Grades from 0 to 90. Higher score: better value. Lower score: worse value. | 1 year | 
| Range of motion in Radial Deviation | Grades from 0 to 15. Higher score: better value. Lower score: worse value. | 1 year | 
| Range of motion in Ulnar deviation. | Grades from 0 to 30. Higher score: better value. Lower score: worse value. | 1 year | 
| Number of shortening millimeters in fracture. | Number of millimeters from 0-10. Higher score: worse value. Lower score: better value. | 6 weeks | 
| Number of ulnar variance millimeters in fracture. | Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value. | 6 weeks | 
| Number of step-off millimeters in fracture. | Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal radius fractures, volar plate, internal fixation, Inmobilization