Informations générales (source: ClinicalTrials.gov)
A Post-market Clinical Follow-up (PMCF) Study to Evaluate Clinical, Radiographic and Patient Reported Outcomes Following a Hip Hemiarthroplasty Surgery Using Corin Devices
Observational
Corin (Voir sur ClinicalTrials)
juin 2023
septembre 2033
18 juillet 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Peter UPEX, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ch Amboise - 37403 - Amboise - France | Vincent NOEL, MD | Contact (sur clinicalTrials) | |||
| Polyclinique Henin Beaumont - 62110 - Henin Beaumont - France | Romain GALMICHE, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Both genders.
2. Adult subjects.
3. 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.
4. The subject is willing to comply with the required follow-up visits as per protocol.
5. The subject has signed a Patient Informed Consent Form (PICF), specific to this
study, and approved by the local EC.
1. Both genders.
2. Adult subjects.
3. 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.
4. The subject is willing to comply with the required follow-up visits as per protocol.
5. The subject has signed a Patient Informed Consent Form (PICF), specific to this
study, and approved by the local EC.
1. Subjects with active infection or sepsis or osteomyelitis.
2. Subjects with unsuitable or insufficient bone support preventing proper fixation of
the prosthesis.
3. Subject with marked bone loss or bone absorption.
4. Subject with metabolic disorders which may impair bone formation or bone quality.
5. Subjects under guardianship.
6. 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.