DePuy Synthes Variable Angle LCP Patella Plating System Study

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Hartford Hospital
Study ID
NCT05824676
Status
Not Yet Recruiting

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Conditions

  • Knee Cap
  • Knee Cap Injury
  • Knee Deformity
  • Knee Discomfort
  • Patella Fracture
  • Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Variable Angle LCP Patella Plating System — DEVICE
    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.
  • Traditional Fixation — DEVICE
    Traditional fixation methods for patellar fracture (screws, suture fixation, wire fixation, other plates).

Study Details

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.

Key Dates

Start date
May 31, 2023
Status verified
Feb 2023
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Depuy Synthes LCP Patella Plating System
    This group will have 18 randomly selected participants, who will receive the Depuy Synthes LCP Patella Plating System for patella fracture.
  • Other: Control/Conventional Fixation
    This group will have 18 randomly selected participants, who will receive the conventional treatment for patella fracture.

Primary Outcome Measure

DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hartford HealthCare The Bone and Joint InstituteHartfordConnecticut06106
Jake R Corsa, BSc
[email protected]
860-972-6685
Bethany Samperi, BSc
[email protected]
860-972-5978
Michael Miranda, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Hartford HealthCare The Bone and Joint Institute· Hartford, CT

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