Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty
Recruiting · NCT05686278 · Observational (researchers observe without assigning treatment) · Lead sponsor: Corin
View the official record on ClinicalTrials.gov →Interventions studied
Bipolar i and cemented stem (Océane+ or Meije)
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
4 locations listed.
- Polyclinique Henin Beaumont - Hénin-Beaumont, France
- Hopital Saint Joseph - Paris, France
- Hopital Diaconesses Croix Saint Simon - Paris, France
- Ch Amboise - Amboise, France, France