NCT06359301招募中不适用
An Open Label, Observational, Prospective, Longitudinal Cohort Study to Evaluate Safety, Clinical and Radiographic Outcomes of Total Hip Arthroplasty With DELTA Revision Cup
Limacorporate S.p.a1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2021年9月14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
- 49
- 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 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup.
详细描述
This is an observational study designed to reflect real life clinical practice as closely as possible. Thus, clinicians are free to choose the method to implant and total hip arthroplasty in accordance with the current local Delta Revision acetabular cup Indication for Use and current clinical practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female in whom a decision has already been made to perform a total hip arthroplasty with DELTA Revision acetabular cup as per indication for use. The decision to implant DELTA revision acetabular cup must be taken prior to, and independently from the decision to enroll the patient. This decision should be made in accorsance with routine clinical practice at the study site concerned.
- •Age ≥ 18 years old
- •All patients mist give written informed consent approved by the study site's Institutinal Review Board (IRB)/Ethical Committee (EC)
- •Patient is able to comply with the protocol
排除标准
- •Adult patients with any DELTA Revision acetabular cup contraindication for use as reported in the current local instruction for use.
- •For female patiens, current pregnancy and/or lactation or planning a pregnancy
结局指标
主要结局
Harris Hip Score (HHS)
时间窗: From preoperative to 2 years after surgery
Overall score from 0 to 100, with 100 being the best outcome
次要结局
- Incidence, type and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up(From preoperative to 2 years after surgery)
- Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup(From preoperative to 2 years after surgery)
- ROM measurement(From preoperative to 2 years after surgery)
- Oxforn Hip Score (OHS)(From preoperative to 2 years after surgery)
- Survival rate(2 years)
研究者
研究点 (1)
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