Hip FracturesHip HemiarthroplastyOsteoarthritis, HipAvascular Necrosis of HipFemoral Neck Fractures
Investigational drug(s) / intervention(s)
Bipolar i and cemented stem (Océane+ or Meije)
Bipolar i and cemented stem (Océane+ or Meije): Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, 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.
Exclusion Criteria:
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 under jusicial protection
7. 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.
Primary outcome measure(s)
Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery. — 2 years Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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