A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Determine if inducible displacement is indicative of adequate fixation
研究概览
简要总结
The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome measures to evaluate early, post-operative implant stability, post-operative implant fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E stabilized polyethylene.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic osteoarthritis of the hip indicating surgical intervention
- •Scheduled to undergo an uncemented total hip arthroplasty (THA)
- •Patients between the ages of 18 and 65, inclusive
- •Ability to give informed consent
- •Patients will be available for follow-up for a minimum of 2 years after surgery
排除标准
- •Patients less than 18 years of age, or older than 65 years of age.
- •Post-traumatic arthritis in the affected hip
- •Rheumatoid arthritis in the affected hip
- •Hip dysplasia in the affected hip
- •Prior arthroplasty of the affected hip
- •Active or prior infection of the affected hip
- •Morbid obesity (BMI > 35)
- •Medical condition precluding major surgery
- •Severe osteoporosis or osteopenia
- •Neuromuscular impairment
- •Patients with known allergy to metals
- •Pregnancy
- •Patients with compromised kidney function
- •Patient is immuno-suppressed
- •Patients that require a femoral head less than 32 mm or greater than 40mm.
研究组 & 干预措施
Vitamin E Polyethylene and RSA
All subjects will have the Vitamin E polyethylene and RSA beads placed during surgery. Subjects will then have standard x-ray images and RSA images taken at specific time points up until 2 years post-operatively.
干预措施: RSA images (Radiation)
结局指标
主要结局
Determine if inducible displacement is indicative of adequate fixation
时间窗: 2 years
Assess the health status and functional outcome of patients with the Continuum® Cup
时间窗: 2 years
Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA
时间窗: 2 years
Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt
时间窗: 2 years
Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head
时间窗: 2 years
Determine if the wear rate of the Vitamin E liner is the same in-vivo as it is in simulation testing
时间窗: 2 years
Assessing the migration pattern of the Continuum® Cup
时间窗: 2 years
次要结局
未报告次要终点