Clinical trial NCT05754320: TBW vs Plating in Olecranon Fractures
Official title: Tension Band Wire Fixation Versus Plating for Simple Displaced Olecranon Fractures: A Long-Term Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Olecranon Fracture
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand score
timeFrame: 1 year
Secondary outcomes:
measure: Oxford elbow score
timeFrame: 1 year
measure: Union rate
timeFrame: 1 year
measure: Complication rate
timeFrame: >1 year
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)
Study officials:
References: