Hip Prospective Study

Официальное название

Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses

Обзор

In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017/745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable. Therefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses. HiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.

Первичные конечные точки

• Survival rate [Срок оценки: Per operative period to 15 years]

Вторичные конечные точки (11)

• Intermediate survival rates [Срок оценки: Per operative period to 10 years]
• Functional improvement [Срок оценки: Per operative period to 15 years]
• Functional improvement [Срок оценки: Per operative period to 15 years]
• Functional improvement [Срок оценки: Per operative period to 15 years]
• Functional improvement [Срок оценки: Per operative period to 15 years]
• Leg length discrepancy [Срок оценки: Pre operative period to 15 years]
• Patient's Pain [Срок оценки: Pre operative period to 15 years]
• Patient's quality of life [Срок оценки: Pre operative period to 15 years]
• Patient's satisfaction [Срок оценки: Post operative period to 15 years]
• Surgeon's satisfaction [Срок оценки: Per operative period to 15 years]
• Adverse events [Срок оценки: Per operative period to 15 years]

Критерии участия

Критерии включения

• Male or female adults
• Planned to be implanted with investigational medical devices per the IFUs:

• Implantation in skeletally mature adults (usually aged 60-65 and over), with an extremely painful and/or disabled joint and insufficiently improved by alternative treatment options after an observation period lasting from a few weeks to a few months
• Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer)
• For an intended purpose and indication listed in the IFUs
• Affiliated to French social security
• Who provided a dated and signed informed consent form

Критерии исключения

• Patient protected by a French legal measure
• Patient not able to express his/her consent as deemed by the investigator
• Patient deprived of liberty or hospitalized without consent
• Pregnant or breastfeeding women
• Patient contraindicated to investigational medical devices implantation per the IFUs
• Patient contraindicated to radiographic follow-up
• Patient a priori not able to meet the follow-up visits as deemed by the investigator
• Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU St Etienne — Saint-Priest-en-Jarez

Идентификаторы

NCT: NCT05956236 · HiPS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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