X-3 Polyethylene Survival Outcomes Study

NCT ID: NCT00493792

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2023-11-01

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.

Detailed Description

This is a prospective, randomized and blinded clinical trial. Participants will be assessed pre-operatively and post-operatively at three months and two, five, seven and ten years. 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 510k clearance) used in a fixed-bearing total knee system in patients undergoing cemented total knee arthroplasty. Specifically, the primary endpoint will be the revision rate at ten years. These results will be measured through radiographs at each post-operative interval with an independent radiograph review being performed after all patients have reached 7 and 10 year follow-up. Secondary results will also be collected and will focus on disease-specific (Knee Society Scores), global (SF-12), and outcome measures. Radiographic results consisting of standing anteroposterior, lateral and Merchant views of the surgical knee will be recorded and analyzed. Completion of the initial investigation will occur at the 10-year interval after the last enrolled patient.

Conditions

Arthroplasty, Replacement, Knee; Total Knee Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: ACTIVE_COMPARATOR

N2Vac Polyethylene

Intervention Type: DEVICE

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

Treatment

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 Type: EXPERIMENTAL

X3 Polyethylene

Intervention Type: DEVICE

Highly cross-linked polyethylene (HXLPE).

Interventions

X3 Polyethylene

Highly cross-linked polyethylene (HXLPE).

Intervention Type: DEVICE

N2Vac Polyethylene

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

Intervention Type: DEVICE

Other Intervention Names

X3; N2Vac

Eligibility Criteria

Inclusion Criteria

1. Subjects willing to sign the informed consent.

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

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

4. Subjects requiring a primary total knee replacement.

5. Subjects with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).

6. Subjects with intact collateral ligaments as determined by the surgeon investigator.

Exclusion Criteria

1. Subjects with inflammatory arthritis.

2. Subjects with a history of total or unicompartmental reconstruction of the affected joint.

3. Subjects that have had a high tibial osteotomy or femoral osteotomy.

4. Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.

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

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

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

8. Subjects with knee fusion to the affected joint.

9. Subjects with an active or suspected latent infection in or about the knee joint.

10. Subjects that are prisoners.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Matthew P. Abdel, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Abdel, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Phoenix, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

06-003093

Identifier Type: -

Identifier Source: org_study_id