Evaluating long-term outcomes of hip hemiarthroplasty surgeries

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

This study is trying to see how well hip hemiarthroplasty surgeries using specific implants work and are safe for adults over a long period of up to 10 years.

Quick facts

• Study type: Observational
• Enrollment: 368 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Corin (Industry-sponsored)
• Locations: 4 sites (Amboise, France and 3 other locations)
• Trial ID: NCT05686278 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults with conditions such as osteoarthritis, avascular necrosis, or specific types of hip fractures who are suitable for hip hemiarthroplasty.

Not a fit: Patients with active infections, significant bone loss, or those who cannot achieve proper fixation of the prosthesis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and performance of specific hip hemiarthroplasty devices, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown success in evaluating similar hip hemiarthroplasty approaches, but this specific study focuses on a particular device under new regulatory requirements.

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, 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 this trial is running

Amboise, France and 3 other locations

• Ch Amboise — Amboise, France, France (Recruiting)
• Polyclinique Henin Beaumont — Hénin-Beaumont, France (Terminated)
• Hopital Saint Joseph — Paris, France (Recruiting)
• Hopital Diaconesses Croix Saint Simon — Paris, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Vanessa GRIMAUD

Conditions Hip Fractures; Hip Hemiarthroplasty; Osteoarthritis, Hip; Avascular Necrosis of Hip; Femoral Neck Fractures; Hemiarthroplasty; Acetabulum