TBW vs Plating in Olecranon Fractures

Not Applicable

Completed

• Conditions: Olecranon Fracture
• Interventions: Device: Plate fixation; Device: Tension band wire fixation

• Registration Number: NCT05754320
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

Background: While the tension band wiring (TBW) technique is commonly used for simple, displaced olecranon fractures, it is associated with complications such as hardware prominence. To date, studies comparing between the efficacy and safety of TBW and plate fixation for these fractures have not provided a conclusive answer.

Purposes: To investigate which of the two techniques provide better functional and radiological outcomes for simple displaced Mayo type 2A olecranon fractures, Which technique provides better patient-reported outcomes, What are the complication rates associated with each technique

Detailed Description

Background: While the tension band wiring (TBW) technique is commonly used for simple, displaced olecranon fractures, it is associated with complications such as hardware prominence. To date, studies comparing between the efficacy and safety of TBW and plate fixation for these fractures have not provided a conclusive answer.

Purposes: To investigate which of the two techniques provide better functional and radiological outcomes for simple displaced Mayo type 2A olecranon fractures, Which technique provides better patient-reported outcomes, What are the complication rates associated with each technique Methods: A long-term, prospective, randomized study on 50 adult patients who underwent surgery to treat acute, simple, displaced olecranon fractures in a Hand and Upper Extremity Surgery Unit at a tertiary care center between November 2012 and October 2017. Patients were randomized on a 1:1 basis to either tension band or plate fixation and were evaluated at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery. Evaluation of long-term complications continued after 1 year as clinically indicated. The primary outcome measure was the 1-year postoperative Disabilities of the Arm, Shoulder and Hand (DASH) score. Additional outcome measures included patient-reported Oxford elbow score, functional (i.e., range of motion) and radiographic assessments and complication rates.

Study Timeline

• Study Start: 2012-11-10
• Primary Completion: 2017-10-28
• Study Completion: 2017-11-01
• Study First Submitted: 2023-02-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study First Posted: 2023-03-03
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. traumatic non-pathological simple olecranon fracture
2. age 18 years or older
3. presentation within 2 weeks of injury.

Exclusion Criteria

1. inability to sign an informed consent
2. inability to comply with follow-up
3. associated elbow fractures
4. open fractures
5. pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plate fixation	Plate fixation	patients suffering simple olecranon fracture, randomized for treatment of plate fixation
Tension Band Wire fixation	Tension band wire fixation	patients suffering simple olecranon fracture, randomized for treatment of tension band wire fixation

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder and Hand score	1 year	1-year postoperative patient reported Disabilities of the Arm, Shoulder and Hand score. Scale - 0 (no disability) to 100 (most severe disability)

Secondary Outcome Measures

Name	Time	Method
Oxford elbow score	1 year	1-year postoperative patient-reported Oxford elbow score. Scale - 0 (worst elbow functional score) to 48 (normal elbow functional score)
Union rate	1 year	Union rate
Complication rate	>1 year	Long term complication rate

Trial Locations

Locations (1)

Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center); 🇮🇱 Be'er Ya'aqov, Israel