TBW vs Plating in Olecranon Fractures

Olecranon Fracture Clinical Trial

Official title:

Tension Band Wire Fixation Versus Plating for Simple Displaced Olecranon Fractures: A Long-Term Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05754320
• Other study ID #: 94/13
• Status: Completed
• Phase: N/A
• Start date: November 10, 2012
• Est. completion date: November 1, 2017

Study information

• Verified date: March 2023
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2017
• Est. primary completion date: October 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Olecranon Fracture
• Ulna Fractures

Intervention

Device:
• Tension band wire fixation
Tension band wire fixation
• Plate fixation
Tension band wire fixation

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)	Be'er Ya'aqov

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of the Arm, Shoulder and Hand score	1-year postoperative patient reported Disabilities of the Arm, Shoulder and Hand score. Scale - 0 (no disability) to 100 (most severe disability)	1 year
Secondary	Oxford elbow score	1-year postoperative patient-reported Oxford elbow score. Scale - 0 (worst elbow functional score) to 48 (normal elbow functional score)	1 year
Secondary	Union rate	Union rate	1 year
Secondary	Complication rate	Long term complication rate	>1 year