Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis

Официальное название

Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis Indicated for the Treatment of Primary and Secondary First Line Gonarthrosis and Revision Arthroplasty - 2 Years Follow-up - A Pilot Study

Обзор

The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery represents a large public health burden. In this context, FH ORTHO company develops FHK®-CK (prosthesis + ancillary equipment) which is a knee prosthesis for complex first intention and revision knee arthroplasty. This new medical device complements the FHK® standard first-line range (CE marked). The FHK®-CK ancillary equipment were designed by expert knee surgeons and is simple, reliable and reproducible. It allows for maximum versatility while remaining compact. By completing the FHK® range of first intention prostheses, the FHK®-CK allows the surgeon to be on the same level as the competitors by having a first intention and semi-constrained prosthesis. This prosthetic arsenal allows the surgeon to opt for the best solution for his patient so that he can regain mobility and a satisfactory quality of life. Also, in case of failure of the FHK® first-line prosthesis, it will provide the surgeon and the patient with a simple alternative to prosthesis replacement. As it has been developed in line with the first intention, inter-compatibility between the two systems is possible, which simplifies the surgical procedure and reduces the risks for the patient.

Вмешательства

• Устройство Total Knee arthroplasty
  The FHK-CK prosthesis (non CE-Marked, class III) is to be implanted with the use of FHK-CK instruments. The surgery has to be performed in accordance with the practice/guidelines, FHK-CK Instruction For Use (IFU) and surgical techniques documents.

Первичные конечные точки

• Functional performance [Срок оценки: Baseline (preoperatively), at 6 weeks, 6 months, 12 months and 24 months after surgery.]

Вторичные конечные точки (8)

• Adverse and serious adverse events evaluation [Срок оценки: Through study completion, an average of 2 years]
• Revision rate evaluation [Срок оценки: At 6 weeks, 6 months, 12 months and 24 months after surgery.]
• Evaluation of patient's tolerance of the FHK-CK prosthesis [Срок оценки: At 6 weeks, 6 months, 12 months and 24 months after surgery.]
• Device deficiencies evaluation [Срок оценки: Through study completion, an average of 2 years]
• Quality of life assessment [Срок оценки: Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.]
• Quality of life assessment [Срок оценки: Baseline (preoperatively), at 6 months, 12 months and 24 months after surgery.]
• Patient's satisfaction about FHK®-CK prosthesis [Срок оценки: At 6 months, 12 months and 24 months after surgery]
• Surgeon's satisfaction about FHK®-CK equipment [Срок оценки: During surgery]

Критерии участия

Критерии включения

• Patient requiring knee arthroplasty for primary or secondary gonarthrosis:

\* For primary intention arthroplasty: Patient with either

• major axial deviation,
• major peripheral failure or
• bone defect;

\* For prosthesis revision surgery: Patient who have had a failed 1st implantation, with or without bone defects.

• Patient able to understand and answer the questionnaires provided by the protocol;
• Subject affiliated to a health insurance system or is a beneficiary;
• Signed informed consent form (ICF) for participation to the research.

Критерии исключения

• Patient with an ongoing acute infection, outside knee to be operated;
• Patient with a mental or neuromuscular disorder that would create an unacceptable risk of prosthetic instability, prosthetic fixation failure or post-operative complications;
• Patient with a known allergy to any of the components of the FHK®-CK implants (Nickel, Cobalt, Chromium);
• Patient with a dependency (drug, alcohol,…) that could affect his/ her ability to comply with the protocol, at the investigator's discretion;
• Patient requiring knee reconstruction;
• Patient with any medically significant findings or significant history that may impact the safety, interpretation of results, and/ or participation of the subject in the clinical trial, as determined by the investigator;
• Patient with an existing knee or hip prosthesis (outside knee to be operated) that may impact the evaluation of the FHK®-CK prosthesis;
• Patient concurrently participating in another clinical trial or who has recently participated in another clinical trial for which the exclusion period has not been completed.
• Vulnerable subjects :

• Pregnant, parturient, or breastfeeding women,
• Subject deprived of liberty, hospitalized without consent or admitted to a health or social establishment for purposes other than that of research,
• Minor,
• Adult under protective supervision (tutorship, curatorship),
• Subject not able to understand the subject information leaflet (e.g. for linguistic or psychiatric reasons) and/or to give informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 7 центров

• Hôpital Privé La Châtaigneraie — Beaumont
• CHRU de la Cavale Blanche — Brest
• Hôpital Beaujon AP-HP — Clichy
• Hôpital Raymond Poincaré AP-HP — Garches
• CH d'Haguenau — Haguenau
• Centre Hospitalier Régional Universitaire de Nancy — Nancy
• Groupe Hospitalier Pitié Salpêtrière AP-HP — Paris

Идентификаторы

NCT: NCT06124482 · 2022-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗