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DePuy Synthes Variable Angle LCP Patella Plating System Study

NCT05824676 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-04-21

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05824676 on ClinicalTrials.gov