Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

Sponsor

Hospital Costa del Sol (Other)

Overall Status

Recruiting

CT.gov ID

NCT06019585

Collaborator

(none)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fractures Internal Fixation; Complications, Mechanical	Device: Splint inmmobilization Device: Bandage immovilization	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 parallel groups, each one receives one treatment2 parallel groups, each one receives one treatment

Masking:

Single (Outcomes Assessor)

Masking Description:

Patient receive the correspondant treatment based on the order of an aleatory numbers table

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 30, 2026

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Splint inmmobilization

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

Device: Splint inmmobilization

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

Active Comparator: Bandage immovilization

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

Device: Bandage immovilization

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

Outcome Measures

Primary Outcome Measures

Pain in Visual Analogue Scale. [1 year]
Points from 1 to 10. Higher score: worse value. Lower score: better value.
Function in Patient Rated Wrist Evaluation Scale. [1 year]
Points from 1 to 100. Higher score: worse value. Lower score: better value.
Range Of Motion in Flexion. [1 year]
Grades from 0 to 70. Higher score: better value. Lower score: worse value.
Range Of Motion in Flexion. [1 year]
Grades from 0 to 80. Higher score: better value. Lower score: worse value.

Secondary Outcome Measures

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.).