The With Or Without Olecranon K-wires Trial

Launched by REGION SKANE · Dec 11, 2022

Keywords

ClinConnect Summary

The With Or Without Olecranon K-wires Trial is studying two different surgical methods for treating a specific type of elbow fracture known as an olecranon fracture (Mayo type 2a and 2b). This trial aims to find out whether using metal wiring alone (cerclage fixation) leads to fewer re-operations and complications compared to a method that uses pins and a metal wire (tension band wiring). If you are 18 years or older and have this type of fracture, you may be eligible to participate in the trial at Skåne University Hospital in Lund and Malmö, Sweden.

If you choose to take part in this study, you will be randomly assigned to one of the two surgical methods. Over the next three years, physiotherapists will follow up with you to assess your recovery, monitor any complications, and evaluate how well your elbow is functioning. Participation is entirely voluntary, and your healthcare team will ensure you understand everything before you decide to join. This study is important because it could help improve treatment options for elbow fractures and reduce the need for additional surgeries in the future.

Gender

ALL

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.

Trial Officials