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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two materials used in knee replacement surgeries to determine if they differ in revision surgery frequency after ten years. It examines whether the new Stryker X3 crosslink material matches the performance of the older N2Vac material regarding reoperation rates and other outcomes. Individuals with osteoarthritis, traumatic arthritis, or avascular necrosis who require a first-time total knee replacement may be suitable candidates. Participants must follow post-surgery care instructions and complete self-evaluations. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance future knee replacement 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. However, if you are receiving chronic steroids for more than 30 days, you may not be eligible to participate.

What prior data suggests that these polyethylene prostheses are safe for knee replacement surgery?

Research has shown that the Stryker X3, a material used in knee replacements, is safe. Studies have found that this material performs well for individuals undergoing total knee replacement surgery. The FDA has approved the X3, confirming it meets safety standards for surgeries.

Specifically, results with the X3 have demonstrated significant improvements in knee function and patient activity levels, even five years post-surgery. Patients generally feel better and can do more after receiving this implant. Additionally, research indicates no major safety concerns with its use in knee replacements.

Overall, evidence suggests that the Stryker X3 is a safe choice for those considering knee replacement surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stryker X3 Polyethylene for knee replacement because it features advanced crosslinking technology, which offers enhanced wear resistance compared to traditional polyethylene materials. This means the X3 Polyethylene could potentially last longer and perform better under the stress of daily activities, reducing the need for revision surgeries. Additionally, it is designed to be used with the Triathlon Posterior Stabilized knee system, which is known for its stability and natural motion support. This combination could improve the overall outcomes and satisfaction for patients undergoing knee replacement surgery.

What evidence suggests that this trial's treatments could be effective for knee replacement surgery?

Research has shown that the Stryker X3 plastic, which participants in this trial may receive, holds promise for knee replacements. Studies have demonstrated significant improvements in knee movement and activity levels five years post-surgery. A special process enhances the X3 material's durability, reducing wear over time. This advanced design may extend its lifespan and lessen the likelihood of needing another surgery later. It presents a strong option for those considering knee replacement surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Matthew Abdel, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Stryker X3 crosslink

How Is the Trial Designed?

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

Citations

1. stryker.com stryker.com/us/en/joint-replacement/products/x3.html

X3 Our X3 polyethylene supports our total hip, knee and shoulder arthroplasty solutions. X3's patented manufacturing process of sequential crosslinking.

2. stryker.com stryker.com/content/dam/stryker/joint-replacement/products/x3/images/X3%20Clinical%20evidence.pdf

X3® Clinical evidence Clinical outcomes demonstrated significant improvements in Knee Society, Short Form 36, and activity scores at a mean follow-up of 5 years. Is Cross-Linked ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00493792

NCT00493792 | X-3 Polyethylene Survival Outcomes Study The primary aim of the study is to compare the survivorship of two types of polyethylene (conventional N2Vac and highly cross-linked X3, both FDA approved via ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7913782/

Plastics in Total Knee Replacement: Processing to ... This article describes the making of conventional and cross-linked poly, packaging, sterilization, processing techniques, and a summary of commercially ...

5. withpower.com withpower.com/trial/phase-1-2007-d5983

X3 Polyethylene for Knee Replacement Surgery What data supports the effectiveness of the treatment Stryker X3 crosslink for knee replacement surgery? Research shows that the X3 polyethylene used in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3772158/

Highly Cross-Linked Polyethylene May Not Have an ... Highly crosslinked polyethylene is safe for use in total knee arthroplasty. Clin Orthop Relat Res. 2008;466:2806–2812. doi: 10.1007/s11999-008-0472-4. [DOI] ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352344119301669

Early failure of sequentially annealed polyethylene in total ... Highly crosslinked polyethylene is safe for use in total knee arthroplasty. Clin Orthop Relat Res, 466 (11) (2008), p. 2806. Crossref View in Scopus Google ...