Clinical Trial

Risk Factors for Development of Non-union of Displaced Midshaft Clavicle Fractures

Study acronym: RisC
Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-21.
Status change: Not Yet Recruiting → Recruiting 2025-02-03
Trial Details
NCT Number NCT06652659
Lead Sponsor Bispebjerg Hospital
Conditions Non-union of Fractures
Enrollment 250 participants
Start Date 2024-10-21
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-04