The With Or Without Olecranon K-wires Trial (NCT05657899) | Clinical Trial Compass
RecruitingNot Applicable
The With Or Without Olecranon K-wires Trial
Sweden200 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Re-operation rate 1.5 months.
Timeframe: Recorded at 1.5 months after intervention.
2
Re-operation rate 3 months.
Timeframe: Recorded at 3 months after intervention.
3
Re-operation rate 12 months.
Timeframe: Recorded at 12 months after intervention.
4
Re-operation rate 36 months.
Timeframe: Recorded at 36 months after intervention.