NCT05649007招募中不适用
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
Gruppo Bioimpianti S.r.l.1 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2022年9月30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
- 630
- 试验地点
- 1
- 主要终点
- stem survival rate
研究概览
简要总结
Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.
详细描述
The main object of the clinical investigation is the evaluation of Stem (SAPHIR) survival rate. The post market clinical follow up will also consider as further seconday endpoints: improvement of paient function, quality of life, safety of device (intended as possible adverse events related to the use of the prosthesis)
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
- •patients>18 years
- •Candidate for primary total hip replacement with femoral stem and acetabular cup
- •if ostheoarthritis patients aged 18 to 85 years
- •if femoral neck fracture patients aged 18 to 90 years
- •patients with social security scheme
- •patients understands the condition of the study and is willing to partecipate for the duration of the clinical investigation
- •patients who gavee consent to partecipare in the clinical investigation
排除标准
- •<18 years
- •if female, pregnant
- •patient who has already had primary hip surgery on the same side
- •local or disseminated neoplastic disease
- •inability to understand the study and agree to partecipate
- •patients cancelling partecipation before surgery
- •patients under guardianship or curatorship
- •patients without a social security scheme
- •patients refusing to partecipate
结局指标
主要结局
stem survival rate
时间窗: 1 year, 3 years, 5 and 10 years
Kaplan Meier survival analysis
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected WoundsArterial UlcersVenous Leg UlcerDiabetic UlcersSurgical WoundSkin GraftPressure UlcerNCT05646121Lohmann & Rauscher99
已完成
不适用
LifeVest Safety and Efficacy in Real Life Settings in FranceLeft Ventricular DysfunctionCardiac EventCardiac ArrythmiasSudden Cardiac DeathNCT03319160Zoll Medical Corporation1,164
已完成
不适用
A Post-market-clinical Follow-up Investigation of Safety and Performance by Decoria® Intense StrongJawline Contour DeficitNCT06562075Bohus Biotech AB114
进行中（未招募）
不适用
A Post Market Clinical Follow-up Study With the aneXys CupArthroplasty, Replacement, HipNCT03274830Mathys Ltd Bettlach102
Unknown
不适用
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long TermShoulder DiseaseShoulder FracturesShoulder Arthroplasty for Revision of Previous TreatmentNCT05284357FX Solutions416