Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

Not Applicable

Recruiting

• Conditions: Distal Radius Fractures; Internal Fixation; Complications, Mechanical
• Interventions: Device: Splint inmmobilization; Device: Bandage immovilization

• Registration Number: NCT06019585
• Lead Sponsor: Hospital Costa del Sol

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2023-07-24
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-25
• Last Update Submitted: 2023-08-25
• Study First Posted: 2023-08-31
• Last Update Posted: 2023-08-31
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Splint inmmobilization	Splint inmmobilization	Distal radius fractures fixed with volar locking plate and immobilized with an antebrachial splint for 3 weeks
Bandage immovilization	Bandage immovilization	Distal radius fractures fixed with volar locking plate and immobilized with a compressive bandage for 3 weeks

Primary Outcome Measures

Name	Time	Method
Pain in Visual Analogue Scale.	1 year	Points from 1 to 10. Higher score: worse value. Lower score: better value.
Range Of Motion in Flexion.	1 year	Grades from 0 to 80. Higher score: better value. Lower score: worse value.
Function in Patient Rated Wrist Evaluation Scale.	1 year	Points from 1 to 100. Higher score: worse value. Lower score: better value.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hospital Costa del Sol; 🇪🇸 Málaga, Spain

Hospital Reina Sofía; 🇪🇸 Córdoba, Spain