Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754320
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2023-02-22
Brief Title:
TBW vs Plating in Olecranon Fractures
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Tension Band Wire Fixation Versus Plating for Simple Displaced Olecranon Fractures A Long-Term Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 ie range of motion and radiographic assessments and complication rates
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 11 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 ie range of motion and radiographic assessments and complication rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None