TBW vs Plating in Olecranon Fractures

NCT ID: NCT05754320

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-10
• Study Completion Date: 2017-11-01

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.

Conditions

Olecranon Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tension Band Wire fixation

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

Group Type: EXPERIMENTAL

Tension band wire fixation

Intervention Type: DEVICE

Tension band wire fixation

Plate fixation

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

Group Type: EXPERIMENTAL

Plate fixation

Intervention Type: DEVICE

Tension band wire fixation

Interventions

Tension band wire fixation

Tension band wire fixation

Intervention Type: DEVICE

Plate fixation

Tension band wire fixation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yonnatan Persitz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)

Be’er Ya‘aqov, , Israel

Countries

Israel

Other Identifiers

94/13

Identifier Type: -

Identifier Source: org_study_id