DePuy Synthes Variable Angle LCP Patella Plating System Study
NCT ID: NCT05824676
Last Updated: 2023-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2023-05-31
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Control/Conventional Fixation
This group will have 18 randomly selected participants, who will receive the conventional treatment for patella fracture.
Traditional Fixation
Traditional fixation methods for patellar fracture (screws, suture fixation, wire fixation, other plates).
Interventions
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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.
Traditional Fixation
Traditional fixation methods for patellar fracture (screws, suture fixation, wire fixation, other plates).
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 74 years old (inclusive)
* Patellar fracture
* Treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital
Exclusion Criteria
* 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
18 Years
74 Years
ALL
No
Sponsors
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Hartford Hospital
OTHER
Responsible Party
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Michael Miranda
Clinical Professor
Locations
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Hartford HealthCare The Bone and Joint Institute
Hartford, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HHC-2022-0283
Identifier Type: -
Identifier Source: org_study_id
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