Post Approval Study: Reflection Ceramic Acetabular System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 456
- 试验地点
- 7
- 主要终点
- Subject Satisfaction Questionnaire
研究概览
简要总结
This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System.
详细描述
This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System. Randomized Non-inflammatory Arthritis, Randomized Inflammatory and Continued Access Cohorts patients previously enrolled in the IDE study will be evaluated annually through five (5) year follow-up. In addition, all patients enrolled in the original study cohorts as well as the continued access patients will be sent a letter questionnaire annually at the 6-10 year postoperative time point to assess the patient's general well-being and if the study components are still in place
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •(Patient must meet all of the following characteristics to be enrolled in the study):
- •Males and females, 21 to 80 years of age, inclusive;
- •Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously;
- •The patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form;
- •The patient will be available for follow-up through at least two years postoperative;
- •The patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (FDA requirement);
- •The patient has a total Harris Hip Score of less than or equal to 60 (FDA requirement);
- •The patient meets none of the
排除标准
- •Exclusion Criteria:
- •(Patient with any of the following characteristics must be excluded from the study):
- •Patients known to have insufficient quantity or quality of bone support resulting from Conditions such as cancer, femoral osteotomy, Girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. Patients with physical conditions tending to place extreme loads on implants such as morbid obesity (> 100 pounds over desirable body weight), Charcot joints, muscle deficiencies, or multiple joint disabilities;
- •Patients with active localized or systemic infection;
- •Patients who have not reached full skeletal maturity;
- •Patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions;
- •The patient is participating in any other pharmaceutical, biologic or medical device clinical investigation;
- •Immunosuppressive disorders - immunosuppressive disorders are chronic conditions characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients receiving therapy to prevent homograft rejection, patients who have acquired immunodeficiency syndrome (AIDS), or auto-immune diseases (except rheumatoid arthritis).
- •Pregnancy.
- •Patients with known sensitivity to materials in the device.
研究组 & 干预措施
Reflection Ceramic-Ceramic Hip System (IP)
Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
干预措施: Reflection Ceramic-Ceramic Total Hip Replacement (Device)
Reflection FSO V (5 hole) (Control)
Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
干预措施: Reflection FSO V Total Hip Replacement (Device)
结局指标
主要结局
Subject Satisfaction Questionnaire
时间窗: Year 6 through Year 10 postoperatively
A subject satisfaction questionnaire was conducted at Year 6, Year 7, Year 8, Year 9, and Year 10 postoperatively. The questionnaire was mailed to enrolled subjects each year (Years 6-10). The question was asked "Are you satisfied with hip?" and subjects responded either "yes" or "no".
Survival of Hip Implant Based on Number of Hips Requiring Revision
时间窗: Postoperatively through Year 10
Revisions were assessed cumulatively from Initial Study Period through Post-Approval Study Period and End of Study/Withdrawal. Implant survival was analyzed based on the number of hip revisions that occurred as well as the cohort for each study arm (IP and Control), but further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Survival of Hip Implant Based on Time Until Revision Required
时间窗: Postoperatively through Year 10
The survival of the implant was analyzed based on the length of time postoperatively until hip revision surgery was required (cumulatively through Initial Study Period and Post-Approval Study Period) for participants who required a revision surgery during the course of the study. The study arms were further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
次要结局
未报告次要终点