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The With Or Without Olecranon K-wires Trial

NCT05657899 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-06-25

No results posted yet for this study

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.

Conditions

  • Olecranon Fracture

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.

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Daniel Wenger, MD, PhD · Department of Orthopedics, Skåne University Hospital and Lund University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2029-09-01
Completion
2029-09-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657899 on ClinicalTrials.gov