TBW vs Plating in Olecranon Fractures

Shamir Medical Center (Assaf-Harofeh)

Status: Completed

Conditions: Olecranon Fracture

Treatments: Device: Tension band wire fixation; Device: Plate fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT05754320

94/13

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Tension Band Wire fixation

Experimental group

Description:

patients suffering simple olecranon fracture, randomized for treatment of tension band wire fixation

Treatment:

Device: Tension band wire fixation

Plate fixation

Experimental group

Description:

patients suffering simple olecranon fracture, randomized for treatment of plate fixation

Treatment:

Device: Plate fixation