X3 Polyethylene for Knee Replacement Surgery

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Chronic steroids

Disqualifiers: Inflammatory arthritis, Neuromuscular deficiency, others

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

Compensation: Varies

Number of Visits: 2

Duration: Surgery and immediate post-operative care

518 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is evaluating whether a new type of knee implant is better than the current implant.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving chronic steroids for more than 30 days, you may not be eligible to participate.

What data supports the effectiveness of the treatment Stryker X3 crosslink for knee replacement surgery?

Research shows that the X3 polyethylene used in knee replacements significantly reduces wear by up to 86% compared to conventional materials, which can help the knee replacement last longer and perform better over time. ^{1 2 3 4 5}

How does the X3 Polyethylene treatment differ from other knee replacement options?

The X3 Polyethylene treatment is unique because it uses a highly crosslinked ultrahigh molecular weight polyethylene, which significantly reduces wear and increases oxidation resistance compared to conventional materials. This makes it more durable and less prone to damage over time, even under high stress conditions. ^{1 2 3 4 6}

Research Team

Matthew Abdel, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Subjects willing to sign the informed consent

Subjects able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations

Male and non-pregnant female subjects ages 21-85 years of age at the time of surgery

Exclusion Criteria

Subjects with a systemic or metabolic disorder leading to progressive bone deterioration

Subjects that are immunologically compromised, or receiving chronic steroids (>30 days)

Subjects bone stock is compromised by disease or infection that cannot provide adequate support and/or fixation to the prosthesis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants are assessed pre-operatively for baseline measurements

1 week

1 visit (in-person)

Treatment

Participants undergo cemented total knee arthroplasty with either N2Vac or X3 polyethylene prostheses

Surgery and immediate post-operative care

1 visit (in-person)

Post-operative Follow-up

Participants are monitored post-operatively at three months and two, five, seven, and ten years for prosthesis survivorship and other outcomes

10 years

Multiple visits (in-person) at specified intervals

Radiographic Review

Independent radiograph review performed after all patients have reached 7 and 10 year follow-up

7-10 years

Treatment Details

Interventions

• Stryker X3 crosslink

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Stryker Orthopaedics X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty.

Group II: Control Active Control 1 Intervention

Stryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Stryker Orthopaedics

Industry Sponsor

Trials

79

Recruited

20,500+

Kevin A. Lobo

Stryker Orthopaedics

Chief Executive Officer since 2012

Bachelor's degree in Commerce from McGill University, MBA from University of Toronto

Dr. Jorge Enrique Diaz

Stryker Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan Medical School

References

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

Is Cross-Linked Polyethylene an Improvement Over Conventional Ultra-High Molecular Weight Polyethylene in Total Knee Arthroplasty? [2019]

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

A highly crosslinked UHMWPE for CR and PS total knee arthroplasties. [2014]

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

The effect of oxidative aging on the wear performance of highly crosslinked polyethylene knee inserts under conditions of severe malalignment. [2008]

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

Knee bearing technology: where is technology taking us? [2013]

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

Wear of sequentially enhanced 9-Mrad polyethylene in 10 million cycle knee simulation study. [2020]

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

Highly crosslinked polyethylene is safe for use in total knee arthroplasty. [2021]