Identifying risk factors for non-healing clavicle fractures
Risk Factors for Development of Non-union of Displaced Midshaft Clavicle Fractures: A Prospective Double-center Cohort Study
Bispebjerg Hospital · NCT06652659
This study is trying to find out what factors make it harder for people with broken collarbones to heal properly, so doctors can better decide who might need surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital (other) |
| Locations | 2 sites (Copenhagen NV and 1 other locations) |
| Trial ID | NCT06652659 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the risk factors associated with non-union in patients who have sustained displaced midshaft clavicle fractures. By examining both patient characteristics and specific fracture-related factors, the study aims to identify which individuals are at higher risk for complications that could lead to prolonged recovery and reduced shoulder function. The research is conducted at two hospitals in Denmark, focusing on patients who present to the emergency room with these types of fractures. The findings could help guide treatment decisions regarding the need for surgical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been admitted to the emergency room with a displaced midshaft clavicle fracture.
Not a fit: Patients with open fractures, pathological fractures, or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who would benefit most from surgery, potentially reducing the incidence of non-union and improving recovery outcomes.
How similar studies have performed: While the approach of identifying risk factors for non-union in clavicle fractures is not widely tested, similar studies in other types of fractures have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age upon study enrollment * Admitted to the emergency room (ER) at BBH or HVH with a displaced midshaft clavicle fracture * Danish social security number * Understand Danish * Able to fill out questionnaire by hand or online. * Provides informed consent prior to initiation of any study-related activities/procedures Exclusion Criteria: * Subject incapable of understanding the patient information or unable to provide informed consent * Open fracture or fracture with risk of skin penetration * Pathological fracture * Clavicle fracture due to polytrauma * Floating shoulder injury * Vascular injury at fracture site * Pregnancy
Where this trial is running
Copenhagen NV and 1 other locations
- Bispebjerg Hospital — Copenhagen NV, Denmark (RECRUITING)
- Hvidovre Hospital — Hvidovre, Denmark (RECRUITING)
Study contacts
- Study coordinator: Ida Tryggedsson, MD
- Email: ida.tryggedsson@regionh.dk
- Phone: +4560600655
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.
Conditions: Non-union of Fractures, Non-union, Midshaft Clavicle Fracture, Clavicle, Midshaft, Midshaft Clavicle, Risc Factors for Non-union