Actively Recruiting

Age: 18Years +
All Genders
NCT06652659

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 2 locations

1

Bispebjerg Hospital

Copenhagen NV, Denmark, 2400

Actively Recruiting

2

Hvidovre Hospital

Hvidovre, Denmark

Actively Recruiting

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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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