Health TrialsbyHealthPanel

DePuy Synthes Variable Angle LCP Patella Plating System Study

ConditionsTraumaPatella FractureKnee CapKnee Cap InjuryKnee DiscomfortKnee Deformity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorHartford Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Depuy Synthes LCP Patella Plating SystemExperimental treatment 1 intervention
Group B: Control/Conventional FixationOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year
3

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.

Time frame
1 year

Secondary outcomes

1

Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)

PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.

Time frame
Post-op day 1
2

Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)

PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.

Time frame
6 weeks
3

Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)

PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.

Time frame
3 months
4

Patient-Reported Outcomes Measurement Information System 10 Global (PROMIS 10 Global)

PROMIS Global-10 is a validated 10-question survey used to assess health care-related quality of life measures such as a participant's function, mental health, numeric pain scale for the general population. The scale runs from 0 to 20. 0 represents severe impairment and low quality of life. A score of 20 represents the best possible quality of life.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hartford Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: