A Randomized, Prospective, Comparative, Multi-Center Clinical Evaluation of the DePuy ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 16
- 主要终点
- Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes
研究概览
简要总结
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.
详细描述
The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to or capable of providing consent to participate in the clinical investigation.
- •Subject is between the ages of 20-75 years, inclusive.
- •Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD).
- •Subject has sufficient bone stock for the hip replacement device.
- •Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device.
排除标准
- •Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation.
- •Subject with a known allergy to metal (e.g. jewelry).
- •Subject has inflammatory arthritis (e.g. rheumatoid arthritis).
- •Subject has active or recent joint sepsis.
- •Subject with marked atrophy or deformity in the upper femur.
- •Subject with a neuromuscular disease where the loss of musculature would affect functional outcome.
- •Subject, in the opinion of the Clinical Investigator, has a history of chronic renal insufficiency (e.g. dialysis).
- •Subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery.
- •Subject with known, active metastatic or neoplastic disease.
- •Subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser.
- •Subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.
结局指标
主要结局
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes
时间窗: 24-month interval.
"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score =\> 80 at 24 months"
次要结局
- T-Test of Harris Hip Total Score Means at 24 Months(24 months)
- Harris Hip Pain Sub Score at 24 Months(24 months)
- Analysis of Metal Ion Release - Serum Chromium(48 months)
- Harris Hip Function Score at 24 Months(24 months)
- Analysis of Metal Ion Release - Erythrocyte Chromium(48 months)
- Analysis of Metal Ion Release - Erythrocyte Cobalt(48 months)
- Analysis of Metal Ion Release - Serum Cobalt(48 months)