Health TrialsbyHealthPanel

Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

ConditionsDistal Radius FracturesInternal Fixation; Complications, Mechanical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHospital Costa del Sol

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Splint inmmobilization

    Device

    After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with a plaster splint of París for 3 weeks

  • Bandage immovilization

    Device

    After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Splint inmmobilizationActive comparator 1 intervention
Group B: Bandage immovilizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain in Visual Analogue Scale.

Points from 1 to 10. Higher score: worse value. Lower score: better value.

Time frame
1 year
2

Function in Patient Rated Wrist Evaluation Scale.

Points from 1 to 100. Higher score: worse value. Lower score: better value.

Time frame
1 year
3

Range Of Motion in Flexion.

Grades from 0 to 70. Higher score: better value. Lower score: worse value.

Time frame
1 year
4

Range Of Motion in Flexion.

Grades from 0 to 80. Higher score: better value. Lower score: worse value.

Time frame
1 year

Secondary outcomes

1

Function in Disabilities of Arm, Shoulder and Hand Scale.

Points from 1 to 150. Higher score: worse value. Lower score: better value

Time frame
1 year
2

Function in Mayo Wrist Score Scale.

Points from 1 to 100. Higher score: worse value. Lower score: better value.

Time frame
1 year
3

Range of motion in Supination.

Grades from 0 to 90. Higher score: better value. Lower score: worse value.

Time frame
1 year
4

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Costa del Sol

Lead sponsor

Source ClinicalTrials.gov
Apply now