Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

Официальное название

A Post-market Clinical Follow-up (PMCF) Study to Evaluate Clinical, Radiographic and Patient Reported Outcomes Following a Hip Hemiarthroplasty Surgery Using Corin Devices

Обзор

This PMCF study is designed to collect safety and efficacy data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Подробное описание

As part of the current clinical remediation work under the new Medical Device Regulation (MDR), limited data have been identified to support the hemiarthroplasty indication for some of Corin femoral stems. Therefore, this PMCF study has been implemented to collect safety and performance data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Вмешательства

• Устройство Bipolar i and cemented stem (Océane+ or Meije)
  Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint

Первичные конечные точки

• Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery. [Срок оценки: 2 years]

Вторичные конечные точки (6)

• Evaluation of mid-term and long-term safety of the study devices up to 10 years. [Срок оценки: 10 years]
• Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU. [Срок оценки: 10 years]
• Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU. [Срок оценки: 10 years]
• Radiographic analysis to detect acetabular erosion [Срок оценки: 2 years]
• Radiographic analysis to detect femoral stem stability [Срок оценки: 2 years]
• Radiographic analysis to detect bipolar head migration [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Both genders.
• Adult subjects.
• Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices based on physical examination, medical history and diagnosis such as: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, revision of failed partial hip replacements in which the acetabulum does not require replacement.
• The subject is willing to comply with the required follow-up visits as per protocol.
• The subject, or a designated trusted person in case the subject is unable to do, has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.

Критерии исключения

• Subjects with active infection or sepsis or osteomyelitis.
• Subjects with unsuitable or insufficient bone support preventing proper fixation of the prosthesis.
• Subject with marked bone loss or bone absorption.
• Subject with metabolic disorders which may impair bone formation or bone quality.
• Subjects under guardianship.
• Subjects under jusicial protection
• Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.

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 · 4 центра

• Ch Amboise — Amboise
• Polyclinique Henin Beaumont — Hénin-Beaumont
• Hopital Saint Joseph — Paris
• Hopital Diaconesses Croix Saint Simon — Paris

Идентификаторы

NCT: NCT05686278 · CSP2021-05-FR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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