NCT05560022撤回不适用
Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty
Societe dEtude, de Recherche et de Fabrication2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年12月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements
研究概览
简要总结
The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Man or women
- •Degenerative or inflammatory hip pathology requiring a total hip replacement
- •Primary or secondary osteoarthritis
- •Advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis
- •Fracture or avascular necrosis
- •Sub-capital fracture and displaced transcervical as well as for bone defects stages I to IIb of PAPROSKY
- •Traumatic joint destruction
- •Following previous intervention, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, total arthroplasty
排除标准
- •People with diminished mental faculties
- •Known current pregnancy
- •Breast-feeding
- •Neurological disorders or other pathologies that may influence locomotion
- •Septic antecedent on hip to operate
- •Patient requiring a bone graft
结局指标
主要结局
Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements
时间窗: per operative period to 10 years
Survival according to Kaplan Meier
次要结局
- Assess the improvement in PMA scores and HHS score as well as patient satisfaction(per operative period to 10 years)
- Adverse events(per operative period to 10 years)
- Patient satisfaction(per operative period to 10 years)
研究者
研究点 (2)
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