Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

Launched by CORIN · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of a specific type of hip surgery called hip hemiarthroplasty, which is often performed to treat hip fractures and other hip conditions. The goal is to gather information about the safety and effectiveness of using certain hip implants (the Corin BiPolar-i shell and Oceane+ or Meije Duo femoral stem) over a period of up to 10 years. Researchers want to better understand how well these implants work and how they impact patients' lives in the long run.

If you're between the ages of 65 and 74 and are considering hip hemiarthroplasty surgery, you may be eligible to participate in this study. To join, you'll need to be in good health overall and have a condition that makes you a good candidate for this surgery, like osteoarthritis or certain types of hip fractures. Participants will be asked to attend regular follow-up appointments to monitor their progress. It's important to note that individuals with active infections, certain bone issues, or conditions that might affect their ability to follow the study procedures won't be able to participate. This trial is a great opportunity to contribute to research that could help improve hip surgery outcomes for future patients.

Gender

ALL

Eligibility criteria

• 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.
• 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 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.