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Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty
RECRUITINGSponsored by Corin
Actively Recruiting
SponsorCorin
Started2023-06-29
Est. completion2026-09
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05686278
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions6
ArthritisAvascular Necrosis of HipFemoral Neck FracturesHip FracturesHip HemiarthroplastyOsteoarthritis, Hip
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Actively Recruiting
SponsorCorin
Started2023-06-29
Est. completion2026-09
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05686278