Clinical trial NCT05824676: DePuy Synthes Variable Angle LCP Patella Plating System Study
Official title: Utility of the Variable Angle LCP Patella Plating System for Traumatic Patellar Fractures: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Patella Fracture
Knee Cap
Knee Cap Injury
Knee Discomfort
Knee Deformity
Keywords: Patella
Plating
trauma
kneecap
injury
knee injuries
knee injury
fracture
break
randomized
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison
timeFrame: 1 year
measure: DePuy Synthes LCP Variable Angle Patella Plating System functional outcomes comparison
timeFrame: 1 year
measure: DePuy Synthes LCP Variable Angle Patella Plating System patient reported outcomes comparison
timeFrame: 1 year
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
timeFrame: Post-op day 1
measure: Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
timeFrame: 6 weeks
measure: Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
timeFrame: 3 months
measure: Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
timeFrame: 9 months
measure: Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)
timeFrame: 1 year
measure: Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)
timeFrame: Post-op day 1
measure: Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)
timeFrame: 6 weeks
measure: Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)
timeFrame: 3 months
measure: Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)
timeFrame: 6 months
measure: Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)
timeFrame: 9 months
measure: Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)
timeFrame: 1 year
measure: Radiographs
timeFrame: 6 weeks
measure: Radiographs
timeFrame: 3 months
measure: Radiographs
timeFrame: 6 months
measure: Radiographs
timeFrame: 9 months
measure: Radiographs
timeFrame: 1 year
measure: Passive Range of Motion (ROM)
timeFrame: 6 weeks
measure: Passive Range of Motion (ROM)
timeFrame: 3 months
measure: Passive Range of Motion (ROM)
timeFrame: 6 months
measure: Passive Range of Motion (ROM)
timeFrame: 9 months
measure: Passive Range of Motion (ROM)
timeFrame: 1 year
measure: Strength
timeFrame: 3 months
measure: Strength
timeFrame: 6 months
measure: Strength
timeFrame: 9 months
measure: Strength
timeFrame: 1 year
measure: Balance
timeFrame: 3 months
measure: Balance
timeFrame: 6 months
measure: Balance
timeFrame: 9 months
measure: Balance
timeFrame: 1 year
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford HealthCare The Bone and Joint Institute
state: Connecticut
Study officials:
References: