Risk Factors for Development of Non-union of Displaced Midshaft Clavicle Fractures
Recruiting now
Conditions studied: Non-union of Fractures
In brief
Clavicle fractures are common and usually heal well without surgery. Most patients recover full shoulder function within a few weeks with conservative treatment, which is the standard in Denmark. However, in cases where the broken ends of the bone do not touch (displaced fractures), there is a higher risk of complications like non-healing (non-union), affecting 11-18% of such cases. Non-union can lead to long-term pain, reduced shoulder function, and a longer recovery time, often requiring multiple follow-up visits. While surgery might prevent these complications for some patients, operating on all displaced fractures would lead to overtreatment. The current challenge is identifying which patients are at risk for non-union and would benefit most from surgery. This study aims to investigate the risk factors for non-union in patients with displaced clavicle fractures by examining both patient characteristics and fracture-related factors. The goal is to use multiple data points to develop a score that can support clinicians and patients in shared decision-making regarding the optimal and individualized treatment for clavicle fractures. This research is important not only for clavicle fractures but also for understanding and treating non-union in other bones like the ulna and tibia, which face similar challenges.
Key facts
- Study ID
- NCT06652659
- Run by
- Bispebjerg Hospital
- People needed
- 250
- Starts
- 2024-10-21
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2025-02-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Bispebjerg Hospital — Copenhagen NV, Denmark (enrolling)
- Hvidovre Hospital — Hvidovre, Denmark (enrolling)
Full record on ClinicalTrials.gov
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