X-3 Polyethylene Survival Outcomes Study

NCT00493792 | Completed Results FDA Device

• 1 other identifier: 06-003093
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Other outcomes such as reoperation rate, complications, radiographic results, and clinical outcomes will be collected. It is hypothesized that X3 would perform equally well to N2Vac at 10 years.

Conditions

Arthroplasty, Replacement, Knee; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Prosthesis Survivorship Free of Revision

  The survival of prostheses free of revision 10 years post operation.

  From operation to 10 years post-operative

Secondary Outcomes (7)

• Prosthesis Survivorship Free of Reoperation

  From operation to 10 years post-operative

• Prosthesis Survivorship Free of Complications

  From operation to 10 years post-operative

• Knee Society Score (KSS)

  Pre-operative (baseline) and 10-years post-operative

• Knee Society Score (KSS): Function

  Pre-operative (baseline) and 10-years post-operative

• 12-Item Short Form Health Survey (SF-12): Mental Health Score

  Pre-operative (baseline) and 10-years post-operative

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Device: N2Vac Polyethylene

Treatment

EXPERIMENTAL

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.

Device: X3 Polyethylene

Interventions

X3 Polyethylene DEVICE

Highly cross-linked polyethylene (HXLPE).

Also known as: X3

Treatment

N2Vac Polyethylene DEVICE

Ultra-high-molecular-weight polyethylene (UHMWPE).

Also known as: N2Vac

Control

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects requiring a primary total knee replacement.
• Subjects with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
• Subjects with intact collateral ligaments as determined by the surgeon investigator.

You may not qualify if:

• Subjects with inflammatory arthritis.
• Subjects with a history of total or unicompartmental reconstruction of the affected joint.
• Subjects that have had a high tibial osteotomy or femoral osteotomy.
• Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
• 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.
• Subjects with knee fusion to the affected joint.
• Subjects with an active or suspected latent infection in or about the knee joint.
• Subjects that are prisoners.

Sponsors & Collaborators

• Mayo Clinic: lead
• Stryker Orthopaedics: collaborator

Study Sites (3)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Limitations and Caveats

Wear related failures require significant lengths of time in which to present, longer-term data are necessary to definitively uncover differential wear and osteolysis risk between HXLPE and UHMWPE. The present investigation strictly utilized cemented femoral and tibial component fixation and posterior stabilized bearing designs. Additionally, 14% of patients were lost to follow-up by 10 years with the potential for bias therein; however, there was no differential attrition between groups.

Results Point of Contact

• Title: Emilee Andersen, M.A., Clinical Research Coordinator
• Organization: Mayo Clinic, Rochester, MN

andersen.emilee@mayo.edu

507-266-9807

Study Officials

• Matthew Abdel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 28, 2007
• Study Start: February 1, 2007
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 6, 2024
• Results First Posted: November 6, 2024

Record last verified: 2024-10

Locations

US (3)