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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the LCP Patella Plating System treatment for knee fractures?

Research shows that the LCP system, used for various fractures, has a high success rate with 93% of fractures healing within the expected time. Additionally, a study on locked plate osteosynthesis for patella fractures found that all patients achieved bone healing by 3 months, with good functional outcomes and no major complications. ^{1 2 3 4 5}

Is the LCP Patella Plating System safe for treating knee fractures?

The LCP system has been used in various fracture treatments and is generally considered safe, with most complications arising from technical errors during surgery rather than the implant itself. In studies, complications like infection and implant issues were noted, but these were often linked to incorrect application rather than the device's design. ^{2 4 6 7 8}

How does the Variable Angle LCP Patella Plating System treatment differ from traditional fixation for knee fractures?

The Variable Angle LCP Patella Plating System is unique because it allows for angular stability through the use of locking screws, which can provide better stabilization for complex fractures compared to traditional fixation methods. This system can be used as both a standard plate and an internal fixator, offering flexibility in treatment. ^{1 2 4 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Locked compression plating for peri- and intra-articular fractures around the knee. [2021]

2. Mexico pubmed.ncbi.nlm.nih.gov

[Experience with the locking compression plates (LCP) in the Hospital Susana López de Valencia--Popayán, Colombia]. [2014]

3. Germany pubmed.ncbi.nlm.nih.gov

Outcomes Following Low-Profile Mesh Plate Osteosynthesis of Patella Fractures. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of the 95-degree angled blade plate and the locking condylar plate for the treatment of distal femoral fractures. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of distal femur fractures with VA-LCP condylar plate: A single trauma centre experience. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Adjunct neutralization plating in patella fracture fixation: a technical trick. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Treating patella fractures with a locking patella plate - first clinical results. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

First clinical results of the Locking Compression Plate (LCP). [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Comparison study on locking compress plate external fixator and standard external fixator for treatment of tibial open fractures]. [2014]

10. England pubmed.ncbi.nlm.nih.gov

Supracondylar osteotomy of the paediatric femur using the locking compression plate: a refined surgical technique. [2021]