Risk Factors for Development of Non-union of Displaced Midshaft Clavicle Fractures
ConditionNon-union of Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBispebjerg Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients at age 18 years or above with a displaced midshaft clavicle fracture in the are of Bispebjerg Hospital and Hvidovre Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-union
Other interventionObservational study looking prospectively at many different factors that may affect non-union of midshaft clavicle fractures.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Patients at age 18 or above with a displaced midshaft clavicle fracture.1 intervention
Trial outcomes
Primary outcomes
1
Radiographic Non-Union assessed by 2-plane radiograph at 26 weeks post-injury
Measure: Radiographic assessment of non-union using standard 2-plane radiographs at 26 weeks post-injury. Non-Union Assessment: Non-union will be defined as the absence of bridging callus on radiographs at 6 months post-injury, measured on standard 2-plane radiographs of the clavicle. The assessment will include measurement of displacement and shortening (measured in millimeters).
Time frame
26 weeksSecondary outcomes
1
Visual Analog Scale (VAS) score
Measure: The Visual Analog Scale (VAS) score is used to measure a person's subjective experience of pain on a scale from 0 to 10, with 0 being no pain and 10 being the worst possible pain. Participants will record a VAS-score daily from week 1 to week 6. Purpose: To investigate if patients who suffer prolonged pain and thus will not show a significant improvement in Visual Analog Scale (VAS) score within 6 weeks from injury are predisposed to the development of non-union.
Time frame
Week 1 to week 62
Shoulder function measured by the quick Disabilities of the Arm, Shoulder and Hand (qDASH) score
Measure: The quick Disabilities of Arm Shoulder Hand (qDASH) measures physical function and symptoms in people with musculoskeletal disorders of the upper limb. The qDASH consists of 11 items that patients rate on a scale of 1 (no difficulty or no symptoms) to 5 (extreme difficulty or severe symptoms). The responses are averaged and then transformed into a score on a scale from 0 to 100. Purpose: To investigate if patients who do not show a significant improvement in range of motion of the shoulder and no significant increase in qDASH score are predisposed to development of non-union.
Time frame
1 week, 6 weeks, 12 weeks, 26 weeks, 52 weeks3
Quality of Life measured by the EuroQol (EQ-5D-5L) questionnaire
Measure: The EuroQol (EQ-5D-5L) questionnaire is used to assess patient-reported outcomes related to health-related quality of life. It evaluates five dimensions, each rated on a 5-point scale, where 1 represents no issues and 5 represents severe issues. The EQ-5D-5L can describe up to 3,125 different health states. A score of 11111 signifies no problems in any dimension, while a score of 55555 reflects extreme problems across all dimensions. Purpose: To investigate whether patients who do not show significant improvement in their EQ-5D-5L score are at increased risk of developing non-union following non-operative treatment.
Time frame
1 week, 6 weeks, 12 weeks, 26 weeks, 52 weeks.4
Radiographic assessment of fracture characteristics
Measure: Radiographic assessment of non-union using standard 2-plane radiographs. Assessment will include description of callus formation (binary: yes/no) and measurement of displacement and shortening (millimeter).
Time frame
1 week, 6 weeks, 12 weeks, 26 weeks, 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov