The With Or Without Olecranon K-wires Trial
The With Or Without Olecranon K-wire (WOW OK) Trial of Tension Band Wire Fixation Versus Cerclage Fixation Without K-wires in Displaced Stable Olecranon Fractures
Region Skane
200 participants
Jan 1, 2023
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria2
- Sustained Olecranon type fracture of Mayo 2a or 2b
- Seeking healthcare in at the Skåne University Hospital in Lund and Malmö, Sweden.
Exclusion Criteria9
- Subjects unable to participate in follow up (for example subjects with active substance abuse, dementia, inability to communicate or understand the questionnaires or subjects living in other administrative healthcare regions).
- Subjects unable to give informed written consent.
- Subject where non operative treatment is indicated due to frailty or severe ongoing disease.
- Fracture not operated within 14 days from the date the fracture was sustained.
- Subjects with severe open fractures of Gustilo-Anderson class III
- Subject with pathological fractures from metastatic disease.
- Subject with simultaneous or previous severe injury to the same arm are excluded for patient reported outcome measures but included for all other outcomes.
- Subjects with previously severe injuries to the same arm will be excludes for PROM analyses but included for reoperation and complication analyses.
- Subjects operated by an orthopedic trauma surgeons that did not attended our education on the study and the interventions, unless surgery is supervised by an orthopedic surgeon that has attended the education the subject will not be excluded.
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Interventions
The intervention is by surgical open reduction and internal fixation of the fracture using two 1.0mm cerclage.
The intervention is by surgical open reduction and internal fixation of the fracture using a 1.0mm cerclage and two 1.6 mm k-wires as described in AO-guidelines.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05657899