A Prospective, Randomized, Multi-center Study Comparing the Ten-Year 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
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- survival rate of polyethylene
研究概览
简要总结
Methodology: This study will be a randomized, multi-center evaluation comparing N2vac polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS total knee system.
Study Duration: 12-18 month enrollment period + 10 year follow-up for each case years total duration
Multi-centre study
Objectives
Primary: To compare the 10 year implant survival of the Triathlon PS total knee system when X3 polyethylene components are used to the same knee system when N2Vac components are used.
Secondary: To compare pain, function, radiographic outcomes, and health related quality of life of subjects in both treatment groups. Safety will be assessed by comparison of adverse events between the groups.
Number of Subjects 384 cases (197 each group)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject requires a primary cemented total knee replacement.
- •The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- •The subject has intact collateral ligaments.
- •The subject has signed the ethic committee approved, study specific Informed Patient Consent Form.
- •The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •The subject has inflammatory arthritis.
- •The subject is morbidly obese, BMI >
- •The subject has a history of total or unicompartmental reconstruction of the affected joint.
- •The subject has had a high tibial osteotomy or femoral osteotomy.
- •The subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
- •The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
- •The subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
- •The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
- •The subject has had a knee fusion at the affected joint.
- •The subject has an active or suspected latent infection in or about the knee joint.
- •The subject is a prisoner.
结局指标
主要结局
survival rate of polyethylene
时间窗: 10 years
次要结局
- pain(10 years)
- radiographic outcomes(10 years)
- function(10 years)
- health related quality of life(10 years)
- adverse events(10 years)
研究者
Michael Dunbar
Principal Investigator
Dalhousie University