DePuy Synthes Variable Angle LCP Patella Plating System Study
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
🗓️ Study Start (Actual)
May 2023
🗓️ Primary Completion (Estimated)
December 2026
✅ Study Completion (Estimated)
December 2027
👥 Enrollment (Estimated)
36
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Hartford, Connecticut, United States
Description
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
Ages Eligible for Study:
18 Years to 74 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
1 March 2023
- First Submitted that Met QC Criteria
10 April 2023
- First Posted
21 April 2023
Study Record Updates
- Last Update Submitted that Met QC Criteria
10 April 2023
- Last Update Posted
21 April 2023
- Last Verified
February 2023