NCT05686278

Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

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
• Phase: —
• Study type: Observational
• Enrollment: 368 (estimated)
• Sponsor: Corin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 stems. Therefore, this PMCF study has been implemented to collect safety and performance data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Conditions

• Hip Fractures
• Hip Hemiarthroplasty
• Osteoarthritis, Hip
• Avascular Necrosis of Hip
• Femoral Neck Fractures

Interventions

Type	Name	Description
DEVICE	Bipolar i and cemented stem (Océane+ or Meije)	Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint

Timeline

• Start date: 2023-06-29
• Primary completion: 2028-09-01
• Completion: 2035-09-01
• First posted: 2023-01-17
• Last updated: 2026-03-18

Locations

4 sites across 1 country: France