DePuy Synthes Variable Angle LCP Patella Plating System Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorHartford Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Males and females

Age between 18 and 74 years old (inclusive)

Patellar fracture

Treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital

Disqualifiers

Age greater than or equal to 75 or less than 18

Patients that are non-ambulatory/limited ambulation prior to their injury

Previous patellar fracture

Pre-existing osteoarthritis of the knee

Trial design

Treatments tested in this trial

  • Variable Angle LCP Patella Plating System
  • Traditional Fixation

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators