What side effects are associated with this type of intervention?

Common side effects of treatments for knee fractures, such as the Depuy Synthes Locking Compression Plate (LCP) Variable Angle Patella Plating System, include infection at the surgical site, hardware irritation or prominence, nonunion or delayed union of the fracture, stiffness or reduced range of motion in the knee, and potential need for hardware removal. Other risks include blood clots, nerve damage, and post-surgical pain.

What prior FDA approvals exist?

The Depuy Synthes Locking Compression Plate (LCP) Variable Angle Patella Plating System is an FDA-approved device aimed at improving the healing of fractured patella by providing stable fixation. This system is being studied to determine its effectiveness compared to traditional fixation methods. While specific prior FDA approvals for similar knee fracture treatments are not detailed in the provided context, the focus remains on devices and techniques that stabilize the fracture and promote healing, such as various plating systems and fixation constructs.

What other types of research exist?

Promising alternatives to the Depuy Synthes LCP Variable Angle Patella Plating System for knee fracture patients include: 1) Biodegradable fixation devices, which offer the advantage of being absorbed by the body, eliminating the need for a second surgery to remove hardware. 2) 3D-printed custom implants, which can be tailored to the patient's specific anatomy for better fit and potentially improved outcomes. 3) Advanced internal bracing systems, which use high-strength suture materials to provide stabilization while allowing for early mobilization and potentially faster recovery. 4) Enhanced biologic augmentation techniques, such as the use of growth factors or stem cells, to promote faster and more effective bone healing.

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Procedure

LCP Patella Plating System vs Traditional Fixation for Knee Fracture

N/A

Waitlist Available

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special device for fixing broken kneecaps in adults aged 18-74. The device holds the broken pieces together securely, which may help them heal better than traditional methods.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include pain at the fracture site, infection from surgery, issues with bone healing like nonunion or malunion (where bones don't heal properly), irritation from hardware placed in the knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DePuy Synthes LCP Variable Angle Patella Plating System clinical outcomes comparison

DePuy Synthes LCP Variable Angle Patella Plating System functional outcomes comparison

DePuy Synthes LCP Variable Angle Patella Plating System patient reported outcomes comparison

Secondary study objectives

Activities of Daily Living-Knee Outcomes Survey (ADL-KOS)

Balance

Passive Range of Motion (ROM)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Depuy Synthes LCP Patella Plating SystemExperimental Treatment1 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 FixationExperimental Treatment1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Depuy Synthes Locking Compression Plate (LCP) Variable Angle Patella Plating System stabilizes knee fractures by allowing screws to be placed at variable angles, accommodating the unique anatomy of the patella and specific fracture patterns. This stability minimizes movement at the fracture site, reducing pain and promoting bone healing. The compression provided by the plate helps bring fractured bone fragments together, essential for proper healing. This method offers improved outcomes compared to traditional fixation methods, potentially leading to faster recovery and better healing.