Actively Recruiting
The With Or Without Olecranon K-wires Trial
Led by Region Skane · Updated on 2025-06-25
200
Participants Needed
2
Research Sites
347 weeks
Total Duration
On this page
Sponsors
R
Region Skane
Lead Sponsor
L
Lund University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Fractures of the elbow tip (olecranon) that leave the elbow joint stable but where the fracture ends are separated (Mayo type 2a and 2b) can be treated with pins and a metal wire (tension band wiring, TBW) or metal wiring alone (cerclage fixation, CF ). Previous studies have reported high re-operation and complication rates following TBW. The current study's hypothesis, based on two retrospective studies, is that CF of these fractures yield lower re-operation rates compared with TBW. The investigators also hypothesize that the overall complication rate will be lower following CF. The aim is to investigate this hypothesis in a randomized controlled trial. Patients that are 18 years or older with Mayo type 2a and 2b olecranon fractures at Skåne University hospital will be invited to the study. Participation is voluntary. Patients who accept participation will be randomly assigned to surgery by either TBW or cerclage fixation. Two hundred participants will be followed by physiotherapists for 36 months post-surgery assessing re-operations, complications, patient reported outcome, and elbow function.
CONDITIONS
Official Title
The With Or Without Olecranon K-wires Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sustained Olecranon type fracture of Mayo 2a or 2b
- Seeking healthcare at Skåne University Hospital in Lund or Malmö, Sweden
- Aged 18 years or older
You will not qualify if you...
- Unable to participate in follow-up due to substance abuse, dementia, communication difficulties, or living outside the healthcare region
- Unable to provide informed written consent
- Non-operative treatment indicated due to frailty or severe ongoing disease
- Fracture not operated within 14 days of injury
- Severe open fractures classified as Gustilo-Anderson class III
- Pathological fractures from metastatic disease
- Severe simultaneous or previous injury to the same arm (excluded from patient-reported outcome measures)
- Surgery performed by an orthopedic trauma surgeon not trained in the study interventions without supervision
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Dept. of Orthopaedics
Lund, Skåne County, Sweden, 22242
Actively Recruiting
2
Dept. of Orthopaedics
Malmö, Skåne County, Sweden, 20502
Actively Recruiting
Research Team
D
Daniel Wenger, MD, PhD
CONTACT
G
Gustav Cornefjord, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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