RecruitingNot Applicable

Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

France368 participantsStarted 2023-06-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Both genders.
✓. Adult subjects.
✓. 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.
✓. The subject is willing to comply with the required follow-up visits as per protocol.
✓. 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

✕. Subjects with active infection or sepsis or osteomyelitis.
✕. Subjects with unsuitable or insufficient bone support preventing proper fixation of the prosthesis.
✕. Subject with marked bone loss or bone absorption.
✕. Subject with metabolic disorders which may impair bone formation or bone quality.
✕. Subjects under guardianship.
✕. Subjects under jusicial protection
✕. 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.

What they're measuring

Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery.

Timeframe: 2 years

Trial details

NCT IDNCT05686278

SponsorCorin

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-09

Contact for this trial

Vanessa GRIMAUD

0667267075 vanessa.grimaud@coringroup.com

View on ClinicalTrials.gov More Hip Fractures trials