Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures

August 25, 2023 updated by: Hospital Costa del Sol

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jose Ignacio Miró Jiménez, MD
  • Phone Number: +34 674501958
  • Email: ppnxmj89@gmail.com

Study Contact Backup

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Reina Sofia
      • Málaga, Spain, 29603
        • Recruiting
        • Hospital Costa del Sol
        • Sub-Investigator:
          • Francisco Rivas, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain in Visual Analogue Scale.
Time Frame: 1 year
Points from 1 to 10. Higher score: worse value. Lower score: better value.
1 year
Function in Patient Rated Wrist Evaluation Scale.
Time Frame: 1 year
Points from 1 to 100. Higher score: worse value. Lower score: better value.
1 year
Range Of Motion in Flexion.
Time Frame: 1 year
Grades from 0 to 70. Higher score: better value. Lower score: worse value.
1 year
Range Of Motion in Flexion.
Time Frame: 1 year
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.
Time Frame: 1 year
Points from 1 to 150. Higher score: worse value. Lower score: better value
1 year
Function in Mayo Wrist Score Scale.
Time Frame: 1 year
Points from 1 to 100. Higher score: worse value. Lower score: better value.
1 year
Range of motion in Supination.
Time Frame: 1 year
Grades from 0 to 90. Higher score: better value. Lower score: worse value.
1 year
Number of participants with posoperative complications.
Time Frame: 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.
1 year
Number of posoperative Fisiotherapy sessions performed.
Time Frame: 1 year
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.
Time Frame: 12 weeks
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.
Time Frame: 1 year
Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value.
1 year
Grades of Dorsal Displacement in fracture.
Time Frame: 6 weeks
Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value.
6 weeks
Range of motion in Pronation.
Time Frame: 1 year
Grades from 0 to 90. Higher score: better value. Lower score: worse value.
1 year
Range of motion in Radial Deviation
Time Frame: 1 year
Grades from 0 to 15. Higher score: better value. Lower score: worse value.
1 year
Range of motion in Ulnar deviation.
Time Frame: 1 year
Grades from 0 to 30. Higher score: better value. Lower score: worse value.
1 year
Number of shortening millimeters in fracture.
Time Frame: 6 weeks
Number of millimeters from 0-10. Higher score: worse value. Lower score: better value.
6 weeks
Number of ulnar variance millimeters in fracture.
Time Frame: 6 weeks
Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value.
6 weeks
Number of step-off millimeters in fracture.
Time Frame: 6 weeks
Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Costa del Sol

Investigators

  • Study Director: Alberto Izquierdo Fernández, Phd, Hospital Reina Sofía ( Córdoba, Spain)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Estimated)

August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003may21PIInmovilizacionfxd

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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