Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

Corin

Status: Enrolling

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

Treatments: Device: Bipolar i and cemented stem (Océane+ or Meije)

Study type: Observational

Funder types: Industry

Identifiers

NCT05686278

CSP2021-05-FR

Details and patient eligibility

About

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.

Full description

As part of the current clinical remediation work under the new Medical Device Regulation (MDR), limited data have been identified to support the hemiarthroplasty indication for some of Corin femoral stems. Therefore, this PMCF study has been implemented to collect safety and performance data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Enrollment: 368 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

368 participants in 1 patient group

Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+)

Description:

Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices

Treatment:

Device: Bipolar i and cemented stem (Océane+ or Meije)