Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices (FH ORTHO Company Hip Observatory).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- FH ORTHO
- 入组人数
- 800
- 试验地点
- 5
- 主要终点
- Survival rate (revision) of the medical device over the long term (maximum 15 years).
研究概览
简要总结
The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling).
The difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an arthroplasty. The observatory must also be able to cover devices used in surgery to repair osteoarticular trauma.
The observatory will be based on the principle of a "dynamic" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits.
Technical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on phone/tablet/computer).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO Company for hip arthroplasty and traumatology, used in accordance with their approved Instruction For Use, in one of the centers participating in the Observatory.
- •Patient is at least 18 years of age.
- •Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally).
- •In some countries, such as France, the patient will have to be socially insured to be included in the study.
排除标准
- •An infection, or latent infection.
- •A mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, failure of prosthetic fixation, or post-operative complications (except for the HIP&GO Double mobility cemented cup and, if applicable, the associated stems and heads when assembled together).
- •Known Insufficient bone quality and/or bone stock.
- •Known allergy to any component of the material listed on the product label.
- •Metabolic diseases that could compromise bone regrowth.
- •Metabolic and/or vascular treatment or disease that may compromise bone healing or consolidation.
- •Drug dependency.
- •Uncooperative patient unable to follow recommendations.
- •Protected adult
研究组 & 干预措施
Total hip arthroplasty (THA) and Revision THA
Patients will be monitored for up to 15 years postoperatively.
干预措施: Hip surgery with FH Ortho devices (Device)
Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty
Patients will be monitored for up to 10 years postoperatively.
干预措施: Hip surgery with FH Ortho devices (Device)
结局指标
主要结局
Survival rate (revision) of the medical device over the long term (maximum 15 years).
时间窗: maximum 15 years.
次要结局
未报告次要终点