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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Costa del Sol

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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