Comparing two surgical methods for treating olecranon fractures
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
This study is testing which surgical method, cerclage fixation or tension band wiring, works better for treating certain types of elbow fractures in adults to see if it leads to fewer complications and re-operations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Lund, Skåne County and 1 other locations) |
| Trial ID | NCT05657899 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of cerclage fixation versus tension band wiring in treating stable olecranon fractures classified as Mayo type 2a and 2b. Patients aged 18 and older at Skåne University Hospital will be randomly assigned to one of the two surgical methods. The study aims to determine which method results in lower re-operation and complication rates. Participants will be monitored by physiotherapists throughout the recovery process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Mayo type 2a or 2b olecranon fractures seeking treatment at Skåne University Hospital.
Not a fit: Patients with severe open fractures, those unable to provide informed consent, or those for whom non-operative treatment is indicated may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced need for re-operations in patients with olecranon fractures.
How similar studies have performed: Previous studies have suggested that cerclage fixation may yield lower re-operation rates compared to tension band wiring, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sustained Olecranon type fracture of Mayo 2a or 2b * Seeking healthcare in at the Skåne University Hospital in Lund and Malmö, Sweden. Exclusion Criteria: * 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.
Where this trial is running
Lund, Skåne County and 1 other locations
- Dept. of Orthopaedics — Lund, Skåne County, Sweden (Recruiting)
- Dept. of Orthopaedics — Malmö, Skåne County, Sweden (Recruiting)
Study contacts
- Principal investigator: Daniel Wenger, MD, PhD — Department of Orthopedics, Skåne University Hospital and Lund University
- Study coordinator: Daniel Wenger, MD, PhD
- Email: daniel.wenger@med.lu.se
- Phone: +46 73-815 15 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.