NCT05007067终止不适用
A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty with DELTA Multihole TT Acetabular Cup.
Limacorporate S.p.a1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2022年2月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Harris Hip Score (HHS)
研究概览
简要总结
This study is aimed to provide a clinical and radiographic evaluation of 50 suitable subjects who underwent a complex primary or a revision Total Hip Arthroplasties with DELTA Multihole TT acetabular cup in 2019 onwards.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, as per indications for use, in 2019 onwards
- •Age ≥ 18 years old
- •Subjects who have signed the written informed consent approved by the reference Ethics Committee (EC)
- •Subjects able to comply with the protocol and to perform all scheduled follow-up visits
排除标准
- •Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, but showed any of the contraindications reported in the Instruction for Use
- •Age < 18 years old
- •Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to:
- •significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery.
- •neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device.
- •known metabolic disorders leading to progressive bone deterioration.
- •Hip replacement on the contralateral side performed within less than one year.
- •Female subjects who are pregnant, nursing or planning a pregnancy.
结局指标
主要结局
Harris Hip Score (HHS)
时间窗: Month 24
The percentage of subjects showing a Harris Hip Score (HHS) equal or greater than "Good" (i.e. equal or greater than 80 points) at 2 years after the surgery.
次要结局
- ROM measurement(Pre-operative - Month 24)
- Survival rate(Month 24)
- VAS Pain(Pre-operative - Month 24)
- Implant stability(Month 24)
- Safety assessment(Intra-operative, Week 2, Week 6, Month 6, Month 12, Month 24)
研究者
研究点 (1)
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