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RECRUITING
NCT05657899
NA

The With Or Without Olecranon K-wires Trial

Sponsor: Region Skane

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-01-01

Completion Date

2029-09-01

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

PROCEDURE

Cerclage fixation

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

PROCEDURE

Tension 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

Malmo, Skåne County, Sweden