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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 518
- 试验地点
- 3
- 主要终点
- Prosthesis Survivorship Free of Revision
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: N2Vac Polyethylene (Device)
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.
干预措施: X3 Polyethylene (Device)
结局指标
主要结局
Prosthesis Survivorship Free of Revision
时间窗: From operation to 10 years post-operative
The survival of prostheses free of revision 10 years post operation.
次要结局
- 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)
- 12-Item Short Form Health Survey (SF-12): Physical Health Score(Pre-operative (baseline) and 10-years post-operative)
- Comparison of Radiographic Success/Failure Between Groups(10 years post-operative)
研究者
Matthew P. Abdel, M.D.
Principal Investigator
Mayo Clinic