DePuy Synthes Variable Angle LCP Patella Plating System Study

Hartford Hospital

Status: Not yet enrolling

Conditions: Knee Cap Injury; Knee Cap; Trauma; Patella Fracture; Knee Deformity; Knee Discomfort

Treatments: Device: Traditional Fixation; Device: Variable Angle LCP Patella Plating System

Study type: Interventional

Funder types: Other

Identifiers

NCT05824676

HHC-2022-0283

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Ipsilateral femoral or tibia fractures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Depuy Synthes LCP Patella Plating System

Experimental group

Description:

This group will have 18 randomly selected participants, who will receive the Depuy Synthes LCP Patella Plating System for patella fracture.

Treatment:

Device: Variable Angle LCP Patella Plating System

Control/Conventional Fixation

Other group

Description:

This group will have 18 randomly selected participants, who will receive the conventional treatment for patella fracture.

Treatment:

Device: Traditional Fixation