Coated vs. Standard Knee Implants for Osteoarthritis

Overseen By Janel Dhooma, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: Infection, Inflammatory arthropathy, others

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

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of knee implants for individuals with knee osteoarthritis, a condition that causes pain and stiffness in the knee joint. The goal is to determine if a special coating on one implant, the Evolution® NitrX™ Knee System, can reduce metal particles in the body, which may cause tissue irritation. Researchers will compare the movement of the implants in the knee and check for metal particles in the blood. This study targets individuals with knee osteoarthritis who require knee replacement surgery and have a slight inward knee curve (varus deformity). Participants must be able to undergo MRI scans and commit to follow-up visits. As an unphased trial, this study allows participants to contribute to innovative research that could enhance knee implant outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these knee implants are safe for patients with osteoarthritis?

Research has shown that the Evolution NitrX Knee System features a special coating designed to reduce metal particles in the body. This coating lowers the risk of allergic reactions to metal in knee implants. Safety checks from other studies have examined how well patients tolerate this implant. Specifically, the coating reduces wear and tear, which can help prevent problems.

The Evolution Knee System is a standard knee implant already used in surgeries. Although both implants have been used in patients, the NitrX version is undergoing further study to ensure its safety and effectiveness. As this is a newer development, ongoing studies continue to gather more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Evolution® NitrX™ Knee System is unique because it features a specialized protective coating designed to enhance durability and reduce inflammation, a common issue with standard knee implants. Unlike traditional knee replacements that can wear down over time, the NitrX coating aims to improve the longevity of the implant, potentially leading to fewer revisions and better long-term outcomes for patients with osteoarthritis. Researchers are excited about this advancement as it could offer a more resilient and patient-friendly option compared to existing treatments.

What evidence suggests that these knee implants are effective for osteoarthritis?

Research has shown that the Evolution NitrX Knee System, a treatment under study in this trial, is designed to reduce the release of metal particles, which can cause reactions in some patients after knee surgery. Studies have found that this implant maintains knee stability while addressing the issue of metal particles. The Evolution NitrX implant aims to prevent problems from these particles, potentially leading to better joint function and patient satisfaction. Previous patients have benefited from the Evolution Medial-Pivot design, which enhances knee stability. By focusing on these improvements, the Evolution NitrX Knee System offers a promising option for those concerned about metal sensitivity after knee replacement surgery. The trial will also evaluate the standard Evolution Total Knee System to compare outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Edward M Vasarhelyi, MD

Principal Investigator

London Health Sciences Centre

Matthew Teeter, PhD

Principal Investigator

London Health Science Centre

Are You a Good Fit for This Trial?

This trial is for adults aged 21-80 with knee osteoarthritis, specifically those who have a varus knee deformity of 0 to 10 degrees and intact ligaments suitable for keeping the posterior cruciate ligament during surgery. Participants must be able to follow up, complete self-evaluations, consent to the study, and have no issues with undergoing MRI scans.

Inclusion Criteria

My knee bends slightly inward.

Patients willing and able to comply with follow-up requirements and self-evaluations

No contraindications to Magnetic Resonance Imaging (MRI)

Exclusion Criteria

I have had an infection before or have one now.

I need surgery involving bone implants or special supports.

I have PCL deficiency.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo pre-operative assessments including blood draws and questionnaires to evaluate baseline health status and metal exposure/sensitivity

1-2 weeks

1 visit (in-person)

Surgery and Initial Recovery

Participants undergo total knee arthroplasty surgery with either the Evolution or Evolution NitrX Total Knee System

2 weeks

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for implant stability and metal levels through radiostereometric analysis, blood draws, and MR imaging

2 years

Multiple visits (in-person) at 6 weeks, 3 months, 6 months, 1 year, and 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including joint function and patient satisfaction assessments

2 years

Multiple visits (in-person) at 3 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Evolution Knee System
• Evolution® NitrX™ Knee System

Trial Overview The study compares two types of knee implants used in total knee arthroplasty: Evolution NitrX Knee System (with a special coating) versus the standard Evolution Knee System. It aims to assess implant stability using radiostereometric analysis (RSA), measure metal particles in blood, examine effects via MRI, and evaluate joint function and patient satisfaction through questionnaires.

How Is the Trial Designed?

Group I: Evolution with NitrX Total Knee Arthroplasty system Experimental Treatment 1 Intervention

Patients will undergo total knee arthroplasty with the NitrX Evolution Total Knee System which has the specialized protective coating

Group II: Evolution Total Knee Arthroplasty system Active Control 1 Intervention

Patients will undergo total knee arthroplasty with the Evolution Total Knee System

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

MicroPort Orthopedics Inc.

Industry Sponsor

Trials

33

Recruited

3,700+

Published Research Related to This Trial

The study involving 80 participants found no significant difference in patient-reported outcomes (Oxford Knee Score) between the newer Journey II BCS and the older Genesis II total knee replacement designs at 6 months post-surgery.

However, the Genesis II group showed superior biomechanical outcomes, including greater walking range of motion and higher peak knee flexion velocity, suggesting it may offer better functional performance compared to the Journey II BCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Journey II bicruciate stabilised (JII-BCS) and GENESIS II total knee arthroplasty for functional ability and motor impairment: the CAPAbility, blinded, randomised controlled trial. McNamara, I., Pomeroy, V., Clark, AB., et al.[2023]

In a study of 88 total knee arthroplasties (TKAs) comparing a new kinematic knee prosthesis to a traditional design, both groups showed similar clinical outcomes after 5 years, with no significant differences in knee society scores or range of motion.

However, the new prosthesis group reported lower incidences of anterior knee pain (8.5% vs 21.9%) and crepitation (14.6% vs 32.9%), suggesting improved patient satisfaction with the newer design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medial tibial bone resorption following total knee arthroplasty comparing a traditional with a kinematic design. Saini, MK., Reddy, CD., Reddy, NR., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04816773

Study Details | NCT04816773 | Post Market ... Percentage of knees survived with no revisions or replacement ... To assess functional scores utilizing Knee Injury and Osteoarthritis Outcome Score (KOOS).

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/K182251.pdf

May 16, 2019 MicroPort Orthopedics, Inc. Ryan Ross Manager ... The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1 ...

3. microportortho.com microportortho.com/products/knees/primary-total-knee-systems/evolutionr-medial-pivot-knee-systems/evolutionr-nitrxtm

Evolution® Medial-Pivot NitrX™ Knee System The Evolution® NitrX™ Medial-Pivot Knee reduces metal ion release, maintaining the proven kinematic benefits of the Medial- Pivot Design, resulting in a ...

4. ctv.veeva.com ctv.veeva.com/study/nitrx-total-knee-arthroplasty-rsa

NitrX Total Knee Arthroplasty RSA - ClinicalTrials.Veeva The primary purpose of this study is to compare the Evolution and Evolution NitrX implant (implants your surgeon uses in total knee arthroplasty ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9693456/

The Evolution, Current Indications and Outcomes of ... Overall, cemented and cementless TKA have great results in modern times and there is still a debate as to which implant is superior. Keywords: ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05151315/nitrx-total-knee-arthroplasty-rsa

NitrX Total Knee Arthroplasty RSA | Clinical Research Trial ... This study will compare the stability of these knee implants (any movement the implant makes after surgery) through the use of specialized xrays.

7. taxtmi.com taxtmi.com/news?id=52697

Dr Chintan Hegde performs India''s First Knee ... The advanced material used in the NitrX™ coating reduces wear and tear inside the joint, making it an excellent option for surgeons looking for ...