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Not yet recruiting NCT05824676

DePuy Synthes Variable Angle LCP Patella Plating System Study

No phase Interventional Trauma Patella Fracture Knee Cap Knee Cap Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Variable Angle LCP Patella Plating System, Traditional Fixation.
Who it may be relevant to
Registry conditions: Trauma, Patella Fracture, Knee Cap, Knee Cap Injury. Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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).

Primary outcome measures

  • DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison [Time frame: 1 year]
  • DePuy Synthes LCP Variable Angle Patella Plating System functional outcomes comparison [Time frame: 1 year]
  • DePuy Synthes LCP Variable Angle Patella Plating System patient reported outcomes comparison [Time frame: 1 year]
Secondary outcome measures (12)
  • Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Time frame: Post-op day 1]
  • Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Time frame: 6 weeks]
  • Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Time frame: 3 months]
  • Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Time frame: 6 months]
  • Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Time frame: 9 months]
  • Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global) [Time frame: 1 year]
  • Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Time frame: Post-op day 1]
  • Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Time frame: 6 weeks]
  • Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Time frame: 3 months]
  • Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Time frame: 6 months]
  • Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Time frame: 9 months]
  • Activities of Daily Living-Knee Outcomes Survey (ADL-KOS) [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Hartford HealthCare The Bone and Joint Institute — Hartford

Identifiers

NCT: NCT05824676 · HHC-2022-0283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗