A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Survivorship of stem
研究概览
简要总结
This is a retro-prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in at least 156 subjects, at up to 10 sites in Australia, who have been implanted with the EMPERION™ Modular Hip System in primary THA procedures to assess its safety and efficacy over 5 years post-surgery.
详细描述
The main aim of the study is to demonstrate that there is no significant difference in survivorship at 5 years in the EMPERION™ primary stem compared to other primary stems for total hip arthroplasty.
Investigational site personnel will review and screen clinical records for potential subjects to be included in the study. Eligible patients will be contacted and follow-up status and implant revision status will be assessed at this initial contact. The subject will be given the option to participate in a prospective 5-year on-site follow-up visit for which they will provide written informed consent. An HREC waiver of informed consent for study participation will be obtained for subjects who are lost to follow-up, deceased or are unwilling/unable to participate in a prospective on-site 5-year follow-up visit, allowing the inclusion of data from all patients implanted with the study device regardless of follow-up status and therefore eliminate selection bias.
Data will be collected retrospectively from the subject pre-surgery, during surgery, at discharge and at 1-year follow-up found in their medical files and prospective data will be collected from the subject's 5-year Follow-up visit and documented on specially designed Case Report Forms (CRFs).
Data to be collected include:
- Subject demographics
- Primary diagnosis for THA
- Additional relevant history and physical findings
- Post-operative follow-up findings at 1 and 5 years
- Radiological Assessment
- Revision by time points
- Adverse Events
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has undergone primary total hip arthroplasty with the EMPERION™ Modular hip system
排除标准
- •Subject received the EMPERION™ THA on the affected hip as a revision for a previously failed THA
- •At the time of surgery, subject had an active infection or sepsis (treated or untreated)
- •At the time of surgery, subject had presence of malignant tumor, metastatic or neoplastic disease
结局指标
主要结局
Survivorship of stem
时间窗: 5 years
次要结局
- Radiographic Assessment(5 years)
- Harris Hip Score(5 years)
- Revision for any reason(5 years)
- Adverse Events(5 years)