Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824676
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-21
First Post:
2023-03-01
Brief Title:
DePuy Synthes Variable Angle LCP Patella Plating System Study
Sponsor:
Hartford Hospital
Organization:
Hartford Hospital
Study Overview
Official Title:
Utility of the Variable Angle LCP Patella Plating System for Traumatic Patellar Fractures A Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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:
The Depuy Synthes Locking Compression Plate LCP Variable Angle Patella Plating System is an FDA approved device The purpose of this study is to see how well the Depuy Synthes LCP Variable Plating System work in fixing a broken kneecap patella Depuy says that the device will improve healing when compared to traditional ways of repairing a broken patella
The goal of this randomized control trial is to learn how well the LCP Variable Plating System works to fix a broken patella kneecap compared to traditional fixation methods in male and females age 18 to 74 with a patellar fracture and being treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital The main question it aims to answer are
To understand if the Depuy Synthes LCP Variable Angle Plating System will provide a better way to help patients recover from a broken patella
Participants will evaluated at specific time points post-op day 1 6 weeks 3 months 6 months and 12 month post-surgery Participants will be asked to
Complete surveys at all evaluation timepoints
Have x-raysradiographs taken at the 6 week 3 month 6 month 9 month and 1 year timepoints
Participants will have a passive range of motion tests done at 6 week 3 month 6 month 9 month and 1 year timepoints
Participants would have strength and balance tests done at the 3 month 6 month 9 month and 1 year timepoints
The goal of this randomized control trial is to learn how well the LCP Variable Plating System works to fix a broken patella kneecap compared to traditional fixation methods in male and females age 18 to 74 with a patellar fracture and being treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital The main question it aims to answer are
To understand if the Depuy Synthes LCP Variable Angle Plating System will provide a better way to help patients recover from a broken patella
Participants will evaluated at specific time points post-op day 1 6 weeks 3 months 6 months and 12 month post-surgery Participants will be asked to
Complete surveys at all evaluation timepoints
Have x-raysradiographs taken at the 6 week 3 month 6 month 9 month and 1 year timepoints
Participants will have a passive range of motion tests done at 6 week 3 month 6 month 9 month and 1 year timepoints
Participants would have strength and balance tests done at the 3 month 6 month 9 month and 1 year timepoints
Detailed Description:
None
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