The With Or Without Olecranon K-wire Trial Comparing Tension Band Wire Fixation and Cerclage Fixation in Displaced Stable Olecranon Fractures
Led by Region Skane · Updated on 2025-06-25
200
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Region Skane
Lead Sponsor
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Lund University
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AI-Summary
What this Trial Is About
Researchers are investigating treatments for stable but displaced fractures of the elbow tip (olecranon), specifically Mayo type 2a and 2b fractures. The study compares two surgical methods: tension band wiring (TBW), which uses pins and metal wire, and cerclage fixation (CF), which uses metal wire alone. Previous studies suggest CF may result in fewer re-operations and complications than TBW, so this trial aims to test that hypothesis in a randomized controlled setting.
Participants will be randomly assigned to receive either cerclage fixation or tension band wiring surgery. Both procedures involve surgical open reduction and internal fixation of the fracture, with cerclage using two 1.0mm wires and TBW using a 1.0mm wire plus two 1.6mm k-wires. The study will follow 200 patients for 36 months after surgery, with follow-up visits at 2 weeks, 6 weeks, 3 months, 12 months, and 36 months. These visits include physiotherapist assessments and a radiograph at 6 months.
During the study, researchers will monitor re-operation rates, complications, patient-reported outcomes using tools like Quick-DASH and SMFA scores, pain levels, elbow motion range, grip strength, and time to return to work. Physiotherapists conducting assessments will not know which surgery was performed. Operation details such as surgery time and radiation exposure will also be recorded. This comprehensive follow-up aims to provide clear results on the benefits and risks of each surgical method.
CONDITIONS
Brief Title
The With Or Without Olecranon K-wires Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Sustained Olecranon type fracture of Mayo 2a or 2b
Seeking healthcare at Skåne University Hospital in Lund or Malmö, Sweden
Aged 18 years or older
Able to provide informed written consent
Able to participate in follow-up visits and complete questionnaires
You will not qualify if you...
Unable to participate in follow-up (due to substance abuse, dementia, communication difficulties, or living outside the healthcare region)
Unable to give informed written consent
Fracture treated non-operatively due to frailty or severe ongoing disease
Fracture not operated within 14 days of injury
Severe open fractures of Gustilo-Anderson class III
Pathological fractures from metastatic disease
Severe or previous injury to the same arm (excluded from patient-reported outcome measures but included for other outcomes)
Surgery performed by an orthopedic trauma surgeon not trained in the study methods without supervision
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Your Study Journey
Screening
Duration - Up to 14 days before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Treatment
Duration - Surgery day and immediate recovery
Participants undergo surgery to fix the olecranon fracture using either cerclage fixation or tension band wiring.
1 surgical procedure (in-person)
Post-operative Follow-up
Duration - Up to 36 months after surgery
Participants attend follow-up visits with a physiotherapist to assess recovery, complications, pain, arm function, and satisfaction after surgery.
Visits at 2 weeks, 6 weeks, 3 months, 6 months (radiograph), 12 months, and 36 months
Cerclage fixation without K-wires is associated with fewer complications and reoperations compared with tension band wiring in stable displaced olecranon fractures in elderly patients.
Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG).
The Short Musculoskeletal Function Assessment Questionnaire (SMFA): cross-cultural adaptation, validity, reliability and responsiveness of the Swedish SMFA (SMFA-Swe).
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: study protocol for a randomized controlled trial.
Gustav Cornefjord, Ioannis Kostogiannis, Cecilia Rogmark...