Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

Hospital Costa del Sol

Status: Enrolling

Conditions: Internal Fixation; Complications, Mechanical; Distal Radius Fractures

Treatments: Device: Bandage immovilization; Device: Splint inmmobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT06019585

003may21PIInmovilizacionfxd

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Splint inmmobilization

Active Comparator group

Description:

Distal radius fractures fixed with volar locking plate and immobilized with an antebrachial splint for 3 weeks

Treatment:

Device: Splint inmmobilization

Bandage immovilization

Active Comparator group

Description:

Distal radius fractures fixed with volar locking plate and immobilized with a compressive bandage for 3 weeks

Treatment:

Device: Bandage immovilization