Evaluating long-term outcomes of hip hemiarthroplasty surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect safety and efficacy data on hip hemiarthroplasty surgeries using Corin BiPolar-i shell and either the Oceane+ or Meije Duo femoral stem over a period of up to 10 years. It is part of a post-market clinical follow-up (PMCF) initiative to gather essential data supporting the use of these devices under the new Medical Device Regulation (MDR). The study will involve adult patients who are clinically suitable for the procedure based on their medical history and diagnosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ch Amboise
  Amboise, France, France Recruiting
• Hopital Saint Joseph
  Paris, France Recruiting
• Polyclinique Henin Beaumont
  Hénin-Beaumont, France Terminated
• Hopital Diaconesses Croix Saint Simon
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Vanessa GRIMAUD
• Email: vanessa.grimaud@coringroup.com
• Phone: 0667267075

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.