Prospective Observational Case Series Analysing Outcomes of Primary Hip Arthroplasty With a Short Cemented Stem (Friendly Short)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year
研究概览
简要总结
Post-marketing observational case series to analyse the functional recover and radiographic outcomes in terms of implant stability and survivorship of primary hip arthroplasty with Friendly short cemented stem.
详细描述
The aim of this case series is to verify the functional recover and radiographic outcomes of primary hip arthroplasty with Friendly short cemented stem.
This is a post-marketing clinical investigation, the product on study is CE marked and used according to the intended use.
It is a national, mono-centre, prospective, observational case series on 100 patients in 1 site.
Primary endpoint is to investigate clinical progression of patients with THA with Friendly short stem from baseline to 1-year follow-up.
The secondary endpoint is to evaluate implant stability and survivorship of implants up to 5 years Follow-up.
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
- •Patients of both genders;
- •Patients of all ages, but > 18 years old;
- •Patients with primary and secondary coxarthrosis;
- •Patients with rheumatoid arthritis;
- •Patients with avascular necrosis;
- •Patients with neck (not diaphyseal) fractures;
- •Patients requiring a primary hip arthroplasty.
排除标准
- •Patients requiring a revision of a previous stem;
- •Patients with proven active or suspicious infections;
- •Patients with known hypersensitivity to used materials;
- •Patients with known active neoplastic or metastatic diseases;
- •Patients with significant neurological or musculoskeletal disorders that may affect functional recover;
- •Patients with proven haemophilic disease;
- •Patients with unwilling or unable to comply with rehabilitation or inability to return for follow-up visits;
- •Women with pregnancy or childbearing capacity or breast-feeding;
- •Subjects already enrolled in other clinical trials.
结局指标
主要结局
change in percentage of the results of the absolute and weighted (age, gender) Harris Hip Score score from baseline to 1 year
时间窗: up to 5 years FU
Change in Range Of Motion from baseline to 1 year.
时间窗: up to 5 years FU
Change in percentage of the results of the Oxford Hip Score baseline to 1 year
时间窗: up to 5 years FU
次要结局
- Any possible adverse event or complication(up to 5 years FU)
- Rate of failure(up to 5 years FU)
- Radiographic stability(up to 5 years FU)