Status:
RECRUITING
Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty
Lead Sponsor:
Corin
Conditions:
Hip Fractures
Hip Hemiarthroplasty
Eligibility:
All Genders
18+ years
Brief 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.
Detailed 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 s...
Eligibility Criteria
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.
Key Trial Info
Start Date :
June 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2035
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT05686278
Start Date
June 29 2023
End Date
September 1 2035
Last Update
March 18 2026
Active Locations (4)
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1
Ch Amboise
Amboise, France, France, 37403
2
Polyclinique Henin Beaumont
Hénin-Beaumont, France, 62110
3
Hopital Saint Joseph
Paris, France, 75014
4
Hopital Diaconesses Croix Saint Simon
Paris, France, 75020