NCT00764530已完成不适用
Keramos Ceramic/Ceramic Total Hip System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 6
- 主要终点
- Alumina/Alumina articulation will perform as well as the alumina/polyethylene.
研究概览
简要总结
Evaluate the safety and efficacy of the CeramTec Acetabular Alumina Insert and CeramTec Alumina head when used with the Foundation Porous Coated Acetabular Shell and an Encore hip stem.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with inflammatory tissue disorders (e.g. rheumatoid arthritis, lupus, etc), osteoarthritis, post-traumatic arthritis or secondary arthritis, or avascular necrosis.
- •Less than 70 on preoperative HHS score
- •Primary total hip replacement
- •Patient is likely to be available for evaluation for the duration of the study.
排除标准
- •Patients with physical conditions that would eliminate adequate implant support or prevent the use of an appropriately sized implant (e.g., tumor)
- •Previous surgery that has adversely affected bone stock (such as some hip pinning or some osteotomies) or prior total hip replacement.
- •Insufficient quality or quantity of bone resulting from conditions such as:
- •Cancer, where radiation has destroyed the available bonestock
- •Congenital dislocation
- •Metabolic bone disease of the upper femur or pelvis
- •Femoral osteotomy revision
- •Girdlestone revision
- •Active infection of the hip joint
- •Old or remote infection
- •Other conditions that lead to inadequate skeletal fixation
- •Neurological conditions that might hinder patient's ability to follow study procedures, e.g., to restrict physical activities (e.g., Severe Parkinson's, CVA on affected side)
- •Patient's mental condition that may interfere with his ability to give an informed consent or willingness to fulfill the required follow-up of the study
- •Mental illness
- •Drug Abuse
- •Alcoholism
- •Conditions that place excessive demands on the implant
- •Charcot's joints
- •Muscle deficiencies
- •Multiple joint disabilities
- •Refusal to modify postoperative physical activities
- •Skeletal immaturity
- •Obesity (50% over recorded body weight mass index)
- •Greater than or equal to 70 on preoperative HHS score
研究组 & 干预措施
Investigational
Experimental
CeramTec Acetabular Alumina Insert and CeramTec Alumina head used with Foundation Porous Coated Acetabular Shell.
干预措施: Alumina/Alumina (Device)
Control Device
Active Comparator
Foundation Porous Coated Acetabular Shell with Polyethylene Insert with the CeramTec Alumina head.
干预措施: Standard (Device)
结局指标
主要结局
Alumina/Alumina articulation will perform as well as the alumina/polyethylene.
时间窗: 5 year
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
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