Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05657899

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

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Region Skane

Lead Sponsor

L

Lund University

Collaborating Sponsor

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 2 locations

1

Dept. of Orthopaedics

Lund, Skåne County, Sweden, 22242

Actively Recruiting

2

Dept. of Orthopaedics

Malmö, Skåne County, Sweden, 20502

Actively Recruiting

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Research Team

D

Daniel Wenger, MD, PhD

G

Gustav Cornefjord, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Daniel Wenger, Gustav Cornefjord, Cecilia Rogmark

https://pubmed.ncbi.nlm.nih.gov/34236459

Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG).

P L Hudak, P C Amadio, C Bombardier

https://pubmed.ncbi.nlm.nih.gov/8773720

The Short Musculoskeletal Function Assessment Questionnaire (SMFA): cross-cultural adaptation, validity, reliability and responsiveness of the Swedish SMFA (SMFA-Swe).

Sari Ponzer, Anne Skoog, Gunnar Bergström

https://pubmed.ncbi.nlm.nih.gov/14763711

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...

https://pubmed.ncbi.nlm.nih.gov/37641082