DePuy Synthes Variable Angle LCP Patella Plating System Study
Utility of the Variable Angle LCP Patella Plating System for Traumatic Patellar Fractures: A Randomized Control Trial
1 other identifier
interventional
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 21, 2023
February 1, 2023
3.6 years
March 1, 2023
April 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison
Comparing the DePuy Synthes LCP Variable Patella Plating System to tradition fixation methods using clinical outcomes measures.
1 year
DePuy Synthes LCP Variable Angle Patella Plating System functional outcomes comparison
Comparing the DePuy Synthes LCP Variable Patella Plating System to traditional fixation methods using functional outcomes measures.
1 year
DePuy Synthes LCP Variable Angle Patella Plating System patient reported outcomes comparison
Comparing the DePuy Synthes LCP Variable Angle Patella Plating System to traditional fixation methods using patient/participant reported outcomes measures.
1 year
Secondary Outcomes (30)
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
Post-op day 1
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
6 weeks
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
3 months
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
6 months
Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
9 months
- +25 more secondary outcomes
Study Arms (2)
Depuy Synthes LCP Patella Plating System
EXPERIMENTALThis group will have 18 randomly selected participants, who will receive the Depuy Synthes LCP Patella Plating System for patella fracture.
Control/Conventional Fixation
OTHERThis group will have 18 randomly selected participants, who will receive the conventional treatment for patella fracture.
Interventions
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 methods for patellar fracture (screws, suture fixation, wire fixation, other plates).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hartford HealthCare The Bone and Joint Institute
Hartford, Connecticut, 06106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- It insures unbiased patient reported outcomes in data collection, the participants are blinded to what arm they are put in.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
March 1, 2023
First Posted
April 21, 2023
Study Start
May 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
April 21, 2023
Record last verified: 2023-02