LCP Patella Plating System vs Traditional Fixation for Knee Fracture

Overseen By Bethany Samperi, Bsc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hartford Hospital

Disqualifiers: Non-ambulatory, Previous fracture, Osteoarthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Depuy Synthes LCP Variable Angle Patella Plating System, to determine if it improves healing from a broken kneecap compared to traditional fixation methods. Participants will receive either the new device or the usual treatment to compare outcomes. The trial includes surveys, x-rays, and physical tests at various intervals over a year to monitor recovery. It suits individuals who have recently broken their kneecap, can walk, and are receiving treatment at Hartford HealthCare or Hartford Hospital. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Variable Angle LCP Patella Plating System is safe for treating knee fractures?

Research shows that the Depuy Synthes Variable Angle LCP Patella Plating System has FDA approval for fixing broken kneecaps, confirming its safety for use. The system uses special plates that fit closely to the bone, stabilizing it and reducing irritation to nearby tissues.

Previous studies have shown that patients generally tolerate this plating system well. It stabilizes both simple and complex knee fractures, aiding recovery. FDA approval for this purpose assures its safety based on thorough evaluations. Although specific data on side effects is not provided here, its approval indicates general safety for its intended use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Variable Angle LCP Patella Plating System is unique because it offers a new approach to fixing knee fractures, specifically those of the patella, or kneecap. Unlike traditional fixation methods that use fixed-angle plates or wires, this system allows for variable angles in the screws, which can provide more tailored and stable support for the fractured bone. Researchers are excited about this treatment because it potentially enhances the healing process by accommodating the unique anatomy of each patient's knee, leading to better outcomes and possibly faster recovery times.

What evidence suggests that the Depuy Synthes LCP Patella Plating System is effective for fixing a broken kneecap?

In this trial, participants will be randomized to receive either the Variable Angle LCP Patella Plating System or traditional fixation for knee fractures. Research has shown that the Variable Angle LCP Patella Plating System effectively stabilizes both simple and complex kneecap fractures. Studies have found that its design reduces irritation to nearby soft tissues, supporting the healing process. Some evidence suggests that patients using this system achieve better surgical results and recover more functionally compared to traditional methods. The system offers flexible options for different fracture types, potentially leading to better pain management and fewer long-term issues. Overall, this device has improved healing outcomes for broken kneecaps. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-74 who have a broken kneecap and are being treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital. It's not for those over 75, non-walkers before injury, with previous patellar fractures, knee arthritis, or other leg bone fractures.

Inclusion Criteria

Treated at Hartford HealthCare The Bone and Joint Institute or Hartford Hospital

I have a broken kneecap.

I am either male or female.

Exclusion Criteria

I have knee osteoarthritis.

I was unable to walk or had limited walking ability before my injury.

I have had a broken kneecap before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive surgical intervention using either the DePuy Synthes LCP Variable Angle Patella Plating System or conventional fixation methods

Immediate post-operative period

1 visit (in-person) on post-op day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations including surveys, radiographs, passive range of motion tests, and strength and balance assessments

12 months

Visits at 6 weeks, 3 months, 6 months, 9 months, and 12 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Traditional Fixation
• Variable Angle LCP Patella Plating System

Trial Overview The study compares the DePuy Synthes LCP Variable Angle Patella Plating System to traditional methods of fixing a broken kneecap. Participants will be randomly assigned to one of the treatments and followed up with surveys, x-rays, range of motion tests, as well as strength and balance assessments over a year.

How Is the Trial Designed?

Group I: Depuy Synthes LCP Patella Plating System Experimental Treatment 1 Intervention

This group will have 18 randomly selected participants, who will receive the Depuy Synthes LCP Patella Plating System for patella fracture.

Group II: Control/Conventional Fixation Experimental Treatment 1 Intervention

This group will have 18 randomly selected participants, who will receive the conventional treatment for patella fracture.

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Citations

1. aofoundation.org aofoundation.org/innovations/trauma/patella-plating-system

Variable Angle Locking Patella Plating System The low-profile plates allow surgeons to achieve stable fixation in simple and complex patella fractures while minimizing soft tissue irritation.

2. jnjmedtech.com jnjmedtech.com/en-US/product/variable-angle-locking-patella-plating-system

Variable Angle Locking Patella Plating System The Variable Angle (VA) Locking Patella Plating System offers a full suite of patella plates to address simple, wedge, and complex fractures.

3. ctv.veeva.com ctv.veeva.com/study/depuy-synthes-variable-angle-lcp-patella-plating-system-study

DePuy Synthes Variable Angle LCP Patella Plating System ... Depuy says that the device will improve healing when compared to traditional ways of repairing a broken patella.

4. clinconnect.io clinconnect.io/trials/NCT05824676

DePuy Synthes Variable Angle LCP Patella Plating System This study aims to find out if this new plating system is better than traditional methods for fixing a broken kneecap. It will involve men and women between the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0968016024001819

Comparison of the treatment of patellar inferior pole ... The combined fixation method was associated with improved surgical outcomes, enhanced functional recovery, better pain management, and reduced long-term ...

6. aofoundation.org aofoundation.org/approved/approvedsolutionsfolder/2021/va-locking-patella-plating-system

VA Locking Patella Plating System The low-profile plates allow surgeons to achieve stable fixation in simple and complex patella fractures while minimizing soft tissue irritation.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K210408.pdf

U.S. FOOD & DRUG - accessdata.fda.gov The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal ...