NCT00493792

X-3 Polyethylene Survival Outcomes Study

A Prospective, Randomized Study Comparing the Survival for X-3 Polyethylene to N2Vac Polyethylene When Used With the Triathlon Posterior Stabilized (PS) Total Knee System.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	X3 Polyethylene	Highly cross-linked polyethylene (HXLPE).
DEVICE	N2Vac Polyethylene	Ultra-high-molecular-weight polyethylene (UHMWPE).

Timeline

• Start date: 2007-02-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2007-06-28
• Last updated: 2024-11-06
• Results posted: 2024-11-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study