A Post-market Clinical Follow-up (PMCF) Study to Evaluate Clinical, Radiographic and Patient Reported Outcomes Following a Hip Hemiarthroplasty Surgery Using Corin Devices

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.

Locations
Other Locations
France
Ch Amboise
NOT_YET_RECRUITING
Amboise
Polyclinique Henin Beaumont
NOT_YET_RECRUITING
Hénin-beaumont
Hopital Saint Joseph
RECRUITING
Paris
Contact Information
Primary
Vanessa GRIMAUD
vanessa.grimaud@coringroup.com
0667267075
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2033-09
Participants
Target number of participants: 368
Treatments
Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+)
Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices
Related Therapeutic Areas
Sponsors
Leads: Corin

This content was sourced from clinicaltrials.gov