Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study

February 18, 2024 updated by: Thanachai Klongsangsorn, Prince of Songkla University
A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ten patients aged 18-75 years with midshaft clavicle fractures were enrolled in the study during February 2022 to February 2023. 6 patients were managed with standard clavicular brace and 4 patients with self-adjustable clavicular brace. All patients were scheduled for follow-up appointments at 1 week, 2 weeks, 4 weeks, 6 weeks and 12 weeks. Results were assessed based on clinical, functional and radiographic outcomes using the DASH questionnaire, pain, measured by VAS, analgesic usage, displacement, shortening, time to union, and patient satisfaction,

Study Type

Interventional

Enrollment (Estimated)

68

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 Locations

  • Thailand
    • Hatyai
      • Songkla, Hatyai, Thailand, 90110
        • Recruiting
        • Prince of Songkla University
        • Contact:

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

Yes

Description

Inclusion Criteria:

  • Patient with aged between 18 - 75 years old
  • Closed isolated fracture midshaft of clavicle within 9 days after the injury date

Exclusion Criteria:

  • After bracing, fracture displacement and/or shortening > 2 cm or fracture comminution > 3 fragments
  • Segmental fracture
  • Open fracture
  • Impending open fracture (soft tissue compromise/skin lesion)
  • Ipsilateral upper extremities fracture which disturbs clavicular bracing
  • Floating shoulder which surgical treatment is indicated.
  • Patients with other injuries (e.g. head injury, chest and abdomen injury) which interrupted clavicular bracing
  • Pathologic fracture
  • Patient has limitation for clavicular brace application
  • Pregnant women

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: self-adjustable clavicular brace
Device: Clavicular brace
Clavicular brace for conservative treatment of closed midshaft clavicular fractures
Active Comparator: standard clavicular brace
Device: Clavicular brace
Clavicular brace for conservative treatment of closed midshaft clavicular fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH
Time Frame: 1, 2, 4, 6, 12 week
DISABILITIES OF THE ARM, SHOULDER AND HAND
1, 2, 4, 6, 12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction
Time Frame: 1, 2, 4, 6, 12 week
Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction
1, 2, 4, 6, 12 week

Collaborators and Investigators

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

Sponsor

Prince of Songkla University

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)

February 1, 2022

Primary Completion (Actual)

February 15, 2024

Study Completion (Estimated)

February 16, 2024

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 18, 2024

First Posted (Estimated)

February 23, 2024

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSU

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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