The With Or Without Olecranon K-wires Trial
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
| Condition(s) | Olecranon Fracture |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | 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 stud |
| Who can participate | 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 prev |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Region Skane |
| Locations | Lund, Skåne County, Sweden; Malmö, Skåne County, Sweden |
| Start date | 2023-01-01 |
| NCT ID | NCT05657899 |
| Official listing | https://clinicaltrials.gov/study/NCT05657899 |