NCT04542174已完成不适用
Prospective Non-Interventional Post Market Clinical Follow-up Study TRJ® - 8 Years Results
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Survival rate of the stem
研究概览
简要总结
The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results
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
- •patients have received a TRJ® prosthesis in 2012
- •Patient did participate in the 2 years results evaluation 2014
- •Patient gave his written consent for study participation
排除标准
- •patient is pregnant
- •patient < 18 years
结局指标
主要结局
Survival rate of the stem
时间窗: at follow-up examination approximately 8 years after primary intervention
The survival of the TRJ® stem prosthesis will be analyzed using the "Kaplan-Meier". Isolated revisions of the inlay and / or of the acetabular components (with the stem being kept in place) are documented, but assessed separately.
次要结局
- Harris Hip Score (HHS)(at follow-up examination approximately 8 years after primary intervention)
- Rate of Adverse and Serious Adverse Events(at follow-up examination approximately 8 years after primary intervention)
- Radiological Outcome: Bone resorption at the medial stem neck(at follow-up examination approximately 8 years after primary intervention)
- Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)(at follow-up examination approximately 8 years after primary intervention)
- Radiological Outcome: Bone resorption at the Trochanter Major(at follow-up examination approximately 8 years after primary intervention)
- Radiological Outcome: Inlay wear(at follow-up examination approximately 8 years after primary intervention)
- Radiological Outcome: Bony Osseointegration or conspicuous features of the cup(at follow-up examination approximately 8 years after primary intervention)
- Radiological Outcome: Heterotopic Ossification(at follow-up examination approximately 8 years after primary intervention)
- Pain Assessment(at follow-up examination approximately 8 years after primary intervention)
- Radiological Outcome: Migration of the stem in mm(at follow-up examination approximately 8 years after primary intervention)
- Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem(at follow-up examination approximately 8 years after primary intervention)
研究者
研究点 (1)
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