Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT00493792
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.
Study:
NCT00493792
Study Brief:
Protocol Section:
NCT00493792