Comparing self-adjustable and standard braces for midshaft clavicle fractures
Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study
This study is testing whether a new self-adjustable brace works better than a standard brace for helping people recover from midshaft clavicle fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Prince of Songkla University Academic / other |
| Locations | 1 site (Songkla, Hatyai) |
| Trial ID | NCT06276218 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a self-adjustable clavicular brace compared to a standard clavicular brace in treating closed midshaft clavicle fractures. A total of ten patients aged 18-75 were enrolled, with six receiving the standard brace and four the self-adjustable version. Participants were monitored over a 12-week period, with assessments based on clinical, functional, and radiographic outcomes, including pain levels, time to union, and patient satisfaction. The study aims to determine which brace provides better recovery outcomes for patients with this type of fracture.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a closed isolated midshaft clavicle fracture occurring within 9 days of injury.
Not a fit: Patients with complex fractures, such as those with significant displacement, comminution, or other injuries that complicate bracing, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with midshaft clavicle fractures, potentially enhancing recovery and patient satisfaction.
How similar studies have performed: While this approach is relatively novel, similar studies comparing different types of braces for fracture management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Songkla, Hatyai
- Prince of Songkla University — Songkla, Hatyai, Thailand (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.