RecruitingNCT06652659

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

Risk Factors for Development of Non-union of Displaced Midshaft Clavicle Fractures: A Prospective Double-center Cohort Study


Sponsor

Bispebjerg Hospital

Enrollment

250 participants

Start Date

Oct 21, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

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Interventions

OTHERNon-union

Observational study looking prospectively at many different factors that may affect non-union of midshaft clavicle fractures.


Locations(2)

Bispebjerg Hospital

Copenhagen NV, Denmark

Hvidovre Hospital

Hvidovre, Denmark

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NCT06652659