Actively Recruiting
Risk Factors for Development of Non-union of Displaced Midshaft Clavicle Fractures
Led by Bispebjerg Hospital · Updated on 2025-02-04
250
Participants Needed
2
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Risk Factors for Development of Non-union of Displaced Midshaft Clavicle Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Bispebjerg Hospital
Copenhagen NV, Denmark, 2400
Actively Recruiting
2
Hvidovre Hospital
Hvidovre, Denmark
Actively Recruiting
Research Team
I
Ida Tryggedsson, MD
CONTACT
A
Arvind von Keudell, MD, MPH, Phd, ass. professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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