NCT05824676

DePuy Synthes Variable Angle LCP Patella Plating System Study

Utility of the Variable Angle LCP Patella Plating System for Traumatic Patellar Fractures: A Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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-rays(radiographs) 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.

Conditions

• Trauma
• Patella Fracture
• Knee Cap
• Knee Cap Injury
• Knee Discomfort
• Knee Deformity

Interventions

Type	Name	Description
DEVICE	Variable Angle LCP Patella Plating System	FDA approved device, 510K number of, K210408. The Variable Angle LCP Patella Plating System is a device that can be formed to a patients specific need with various anchoring points to best fix what is needed for fixation.
DEVICE	Traditional Fixation	Traditional fixation methods for patellar fracture (screws, suture fixation, wire fixation, other plates).

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-04-21
• Last updated: 2023-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study