NCT05721859招募中不适用
Medacta M-Vizion™ Macroscopic Radiographic Study, Multi-center, Post-Market Outcomes Study
Medacta USA7 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- subsidence
研究概览
简要总结
Study of the patient's subsidence after revision hip arthroplasty by assessing gross stem subsidence in the femoral canal.
详细描述
The aim of this study is to evaluate the M-Vizion modular stem performance in patients who undergo total hip replacement according to the standard practice. It is expected that subjects receiving revision hip arthroplasty with the Medacta M-Vizion™ modular hip stem will have less than 5mm of stem subsidence at 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- •Ability to understand and provide written authorization for use and disclosure of personal health information.
- •Subjects who are able and willing to comply with the study protocol and follow-up visits.
- •Patients requiring a revision total hip replacement.
- •Subjects undergoing revision THA who will receive an M-Vizion femoral component according to the indications for use.
- •Male and female patients ages 21 - 80 years of age at the time of surgery.
排除标准
- •Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- •Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
- •Patients bone stock is compromised by disease or infection, which could possibly prevent adequate support and/or fixation to the prosthesis.
- •Patients with an active or suspected latent infection in or about the hip joint.
- •Patients that are incarcerated.
结局指标
主要结局
subsidence
时间窗: 2 year post-op visit (± 6 months)
Occurrence of subsidence \>5mm
次要结局
未报告次要终点
研究者
研究点 (7)
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