Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study With Long Term Data Collection for the Accolade® II Hip Stem
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 367
- 试验地点
- 23
- 主要终点
- Success Rate
研究概览
简要总结
The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip systems in the literature, through absence of femoral head dislocation at 10 years postoperative.
详细描述
This study is a prospective, open-label, post-market, non-randomized, multi-center, clinical evaluation of the Restoration® ADM X3® Acetabular System for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is 350 cases, all of which will receive the Restoration® ADM X3® Acetabular System. A minimum of 100 cases (within the study population) will receive the Accolade® II Hip Stem. The remaining cases will receive any other compatible Stryker femoral component.
Data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient has signed an IRB/EC approved, study specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female, skeletally mature and age 18-75 years at time of study device implantation.
- •Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- •Patient is a candidate for a primary cementless acetabular replacement.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Patient has a Body Mass Index (BMI) ≥
- •Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- •Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- •Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
- •Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
- •Patient has a known sensitivity to device materials.
- •Patient is a prisoner.
结局指标
主要结局
Success Rate
时间窗: 10 years postoperative
Defined as absence of postoperative femoral head dislocation.
次要结局
- Harris Hip Score (HHS) Score Improvement From Preoperative Score(pre-op, 6 week, 1,2,3,4,5 years. 7 and 10 years were optional.)
- All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System(10 years)
- Patient Satisfaction and Pain: Follow-up Questionnaire(6-10 years)
- Radiographic Stability Rates(6 week,1, 2, 3, 4, 5 years)
- Complication Rates for Psoas Impingement and Associated Groin Pain(10 years)
- Short Form-12 (SF-12) Improvement From Preoperative Score(preop, 6 week, 1,2,3,4,5 years)
- Lower Extremity Activity Scale (LEAS) Improvement From Preoperative Score(preop, 6 week, 1,2,3,4,5 years)
- EQ-5D Index Score Improvement From Preoperative Score(preop, 6 week, 1,2,3,4,5 years)
- Percentage of Cases Which Did Not Have Any Component Revised(10 years)