Post Market Clinical Follow-up of Knee Surgery Using FH ORTHO SAS Medical Devices (FH ORTHO SAS Knee Observatory)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- FH ORTHO
- 入组人数
- 487
- 试验地点
- 10
- 主要终点
- Revision rate
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 instructions for use (IFU).
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 knee arthroplasty. The observatory must also be able to cover devices used in ligament reconstruction surgery.
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 smartphone/tablet/computer) when feasible.
The data to be collected and the different follow-up times are based on our state-of-the-art, clinical evaluation plans and clinical evaluation reports.
详细描述
PMCF as part of CE mark renewal, to answer questions related to the safety and clinical performance of the devices, when used according to their approved instructions for use.
This is an European, prospective and retrospective, multicenter, non-comparative study.
Randomization is considered impossible due to surgeon preference, anatomical conditions and other patient factors, and the use of different techniques.
This observatory is non-comparative, due to the absence of a gold standard and the technical, logistical and contractual constraints involved.
This PMCF study (CE-marked MD, any class, used as intended) provide additional non-burdensome and non-invasive procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 SAS for knee arthroplasty and ligament reconstruction, used in accordance with their approved IFU, in one of the centers participating in the Observatory.
- •Patient is at least 18 years old at the time of surgery
- •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
- •For Arthroplasty:
- •Infection, or latent infection
- •A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery
- •Insufficient bone stock for proper implant fixation
- •It is the surgeon's responsibility to make sure that the patient does not have any known allergies to one of the compounds of the material listed on the product label.
- •Metabolic diseases that might compromise bone regrowth
- •Drug addiction
- •Incomplete bone growth
- •For Ligament reconstruction:
- •Infection, or latent infection
- •A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery
- •Insufficient bone stock
- •Known allergies to one of the compounds of the material listed on the product label.
- •Metabolic diseases that might compromise bone regrowth
- •Uncooperative patient unable to follow recommendations
- •As the medical devices are used in real life according to their indications, pregnant or breastfeeding women are not excluded from the study, but for safety reasons it is not advisable to include them in the study.
结局指标
主要结局
Revision rate
时间窗: 2 months, 3-6 months, 1 year, 2 years, 5 years
Evaluate the revision rate at the longest follow-up possible for ligament reconstruction arm
次要结局
- International Knee Documentation Committee (IKDC 2000) score(Pre-operative, 1 year, 2 years)
- Complications/Adverse events(During surgery, Immediate (0-2months), 3-6months, 1 year, 2 years, 5 years)
- Tegner activity level scale(Pre-operative, 1 year, 2 years)
- Lysholm Knee Scoring Scale(Pre-operative, 1 year, 2 years)
- Visual Analogue Scale (VAS)(1 year, 2 years, 5 years)
- ASA (American Society of Anesthesiologists)-score(Pre-operative)
- International Knee Society (IKS 2011) score(Pre-operative, 3-6months, 1 year, 2 years, 5 years, 10 years)
- Knee laxity (clinical section)(Pre-operative, 3-6 months)