NCT05686278 Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty
| NCT ID | NCT05686278 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Corin |
| Condition | Hip Fractures |
| Study Type | OBSERVATIONAL |
| Enrollment | 368 participants |
| Start Date | 2023-06-29 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 368 participants in total. It began in 2023-06-29 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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, 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: 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 under jusicial protection 7. 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.
Contact & Investigator
Christophe HULET, MD, PhD
STUDY CHAIR
University Hospital, Caen
Frequently Asked Questions
Who can join the NCT05686278 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05686278 currently recruiting?
Yes, NCT05686278 is actively recruiting participants. Contact the research team at vanessa.grimaud@coringroup.com for enrollment information.
Where is the NCT05686278 trial being conducted?
This trial is being conducted at Amboise, France, Hénin-Beaumont, France, Paris, France, Paris, France.
Who is sponsoring the NCT05686278 clinical trial?
NCT05686278 is sponsored by Corin. The principal investigator is Christophe HULET, MD, PhD at University Hospital, Caen. The trial plans to enroll 368 participants.