NCT01257568已完成不适用
A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Survival Rate of the Rejuvenate Modular Stem/Neck
研究概览
简要总结
This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years and clinical outcomes for up to 10 years after surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
- •Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- •Patient is a candidate for a primary cementless total hip replacement.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- •Patient's operative femur templates to Rejuvenate® Modular Stem size 7-12.
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
Survival Rate of the Rejuvenate Modular Stem/Neck
时间窗: 5 years postoperative
The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.
次要结局
- Biomechanical Measurement of Femoral Offset(6 weeks)
- Mean SF-12 Scores at Each Visit(pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year)
- Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)(6 wks,1,2,3,4,5 yrs)
- Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation(6 weeks)
- Mean Harris Hip Score at Each Visit(pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year)
- Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit(pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year)
- Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation(6 weeks)
研究者
研究点 (6)
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