TBW vs Plating in Olecranon Fractures
Tension Band Wire Fixation Versus Plating for Simple Displaced Olecranon Fractures: A Long-Term Prospective Randomized Trial
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 3, 2023
CompletedMarch 3, 2023
March 1, 2023
5 years
February 22, 2023
March 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Oxford elbow score
1 year
Union rate
1 year
Complication rate
>1 year
Study Arms (2)
Tension Band Wire fixation
EXPERIMENTALpatients suffering simple olecranon fracture, randomized for treatment of tension band wire fixation
Plate fixation
EXPERIMENTALpatients suffering simple olecranon fracture, randomized for treatment of plate fixation
Interventions
Eligibility Criteria
You may qualify if:
- traumatic non-pathological simple olecranon fracture
- age 18 years or older
- presentation within 2 weeks of injury.
You may not qualify if:
- inability to sign an informed consent
- inability to comply with follow-up
- associated elbow fractures
- open fractures
- pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)
Be’er Ya‘aqov, 70300, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 3, 2023
Study Start
November 10, 2012
Primary Completion
October 28, 2017
Study Completion
November 1, 2017
Last Updated
March 3, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share