NCT05657899 The With Or Without Olecranon K-wires Trial
| NCT ID | NCT05657899 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Olecranon Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-01-01 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Daniel Wenger, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Orthopedics, Skåne University Hospital and Lund University
Frequently Asked Questions
Who can join the NCT05657899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Olecranon Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05657899 currently recruiting?
Yes, NCT05657899 is actively recruiting participants. Contact the research team at daniel.wenger@med.lu.se for enrollment information.
Where is the NCT05657899 trial being conducted?
This trial is being conducted at Lund, Sweden, Malmö, Sweden.
Who is sponsoring the NCT05657899 clinical trial?
NCT05657899 is sponsored by Region Skane. The principal investigator is Daniel Wenger, MD, PhD at Department of Orthopedics, Skåne University Hospital and Lund University. The trial plans to enroll 200 participants.