RecruitingNot ApplicableNCT05657899

The With Or Without Olecranon K-wires Trial

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


Sponsor

Region Skane

Enrollment

200 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Cerclage fixation and a procedure called Tension band wiring for people with olecranon fracture. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECerclage fixation

The intervention is by surgical open reduction and internal fixation of the fracture using two 1.0mm cerclage.

PROCEDURETension band wiring

The intervention is by surgical open reduction and internal fixation of the fracture using a 1.0mm cerclage and two 1.6 mm k-wires as described in AO-guidelines.


Locations(2)

Dept. of Orthopaedics

Lund, Skåne County, Sweden

Dept. of Orthopaedics

Malmö, Skåne County, Sweden

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NCT05657899


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