NCT01285843已完成不适用
Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.
研究概览
简要总结
This is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
- •Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use (enclosure 2)).
- •Patients must be willing to comply with the pre and post-operative evaluation schedule.
- •Patients with only one lower limb arthroplasty
排除标准
- •Patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism
- •Patients with osteoporosis (pre-op T-score < -2,5)
- •Patients with significant comorbidities
- •Patients with both hip and knee arthroplasty
- •Patients with restricted mobility
- •Patient with severe hip contracture
- •Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
结局指标
主要结局
Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.
时间窗: 0-12 months
次要结局
- Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.(6 months, 1 year)
- Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.(6 months, 1 year)
- Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score(6 weeks, 6 months, 1 year)
研究者
研究点 (2)
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