A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3◊ Acetabular System in Patients With Degenerative Hip Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 479
- 试验地点
- 8
- 主要终点
- Implant Survivorship
研究概览
简要总结
The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.
详细描述
This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem.
Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following characteristics for inclusion in the study.
- •Patient is 18-75 years old and he/she is skeletally mature
- •Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/DDH or inflammatory joint disease (e.g., rheumatoid arthritis)
- •Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
- •The patient is willing to comply the follow-up schedule
排除标准
- •Subjects with any of the following characteristics must be excluded from the participation in the study.
- •Patient has active infection or sepsis (treated or untreated)
- •Patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse.
- •Patients with acute hip trauma (femoral neck fracture)
结局指标
主要结局
Implant Survivorship
时间窗: up to 10 years post-operatively
Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants.
次要结局
- Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS)(Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years)
- Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS)(Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years)
- Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating(Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years)
- Radiographic Findings: Atrophy(1 years, 3 years, 5 years, 7 years, 10 years)
- Radiographic Findings: Hypertrophy(1 years, 3 years, 5 years, 7 years, 10 years)
- Radiographic Findings: Osteolysis(1 years, 3 years, 5 years, 7 years, 10 years)
- Radiographic Findings: Radiolucent Lines (RLL)(1 years, 3 years, 5 years, 7 years, 10 years)