A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years.
研究概览
简要总结
This study seeks to find out if the tibial and patellar components of the Stryker Triathlon Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.
详细描述
Primary Hypothesis:
The investigators expect the tibial and patellar components of the Stryker Triathlon Tritanium knee to achieve adequate fixation to the underlying bone.
Secondary Hypotheses:
The investigators expect that there will be no continuous migration between one and two years post-operative in the Triathlon Tritanium components.
The investigators expect to see a correlation between radiolucent lines and migration characteristics using RSA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic osteoarthritis of the knee indicating surgical intervention
- •Scheduled to undergo a total knee arthroplasty
- •Patients between the ages of 18 and 80, inclusive
- •Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling
排除标准
- •Significant co-morbidity affecting ability to ambulate
- •Prior arthroplasty, patellectomy or osteotomy with the affected knee
- •Active or prior infection of the affected knee
- •Morbid obesity (BMI > 40)
- •Medical condition precluding major surgery
- •Severe osteoporosis
- •Neuromuscular impairment
- •Pregnancy
- •Inability to give informed consent
- •Inability to return for follow-up visits for a minimum of two years after surgery
- •Currently participating in any other surgical intervention study
- •Known allergy to metals
- •Flexion contracture greater than 15°
- •Extension lag greater than 10°
- •Tibial subluxation greater than 10 mm on standing AP radiograph
- •Lateral or medial collateral ligament instability (> 10° varus/valgus)
- •Leg length discrepancy greater than 10 mm
结局指标
主要结局
Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years.
时间窗: 3 years
次要结局
- Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.(3 years)
研究者
Scott Sporer
Medical Director, Orthopedic Institute
Central DuPage Hospital