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TBW vs Plating in Olecranon Fractures

Primary Purpose

Olecranon Fracture

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tension band wire fixation
Plate fixation
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Olecranon Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: traumatic non-pathological simple olecranon fracture age 18 years or older presentation within 2 weeks of injury. Exclusion Criteria: inability to sign an informed consent inability to comply with follow-up associated elbow fractures open fractures pregnancy.

Sites / Locations

  • Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tension Band Wire fixation

Plate fixation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Oxford elbow score
1-year postoperative patient-reported Oxford elbow score. Scale - 0 (worst elbow functional score) to 48 (normal elbow functional score)
Union rate
Union rate
Complication rate
Long term complication rate

Full Information

First Posted
February 22, 2023
Last Updated
March 2, 2023
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05754320
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2012 (Actual)
Primary Completion Date
October 28, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olecranon Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tension Band Wire fixation
Arm Type
Experimental
Arm Description
patients suffering simple olecranon fracture, randomized for treatment of tension band wire fixation
Arm Title
Plate fixation
Arm Type
Experimental
Arm Description
patients suffering simple olecranon fracture, randomized for treatment of plate fixation
Intervention Type
Device
Intervention Name(s)
Tension band wire fixation
Intervention Description
Tension band wire fixation
Intervention Type
Device
Intervention Name(s)
Plate fixation
Intervention Description
Tension band wire fixation
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand score
Description
1-year postoperative patient reported Disabilities of the Arm, Shoulder and Hand score. Scale - 0 (no disability) to 100 (most severe disability)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Oxford elbow score
Description
1-year postoperative patient-reported Oxford elbow score. Scale - 0 (worst elbow functional score) to 48 (normal elbow functional score)
Time Frame
1 year
Title
Union rate
Description
Union rate
Time Frame
1 year
Title
Complication rate
Description
Long term complication rate
Time Frame
>1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: traumatic non-pathological simple olecranon fracture age 18 years or older presentation within 2 weeks of injury. Exclusion Criteria: inability to sign an informed consent inability to comply with follow-up associated elbow fractures open fractures pregnancy.
Facility Information:
Facility Name
Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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TBW vs Plating in Olecranon Fractures

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