Bipolar i and cemented stem (Océane+ or Meije)
DeviceHip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint
NCT Number: NCT05686278
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ch Amboise, Amboise, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint
Time frame: 2 years
Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.
Time frame: 10 years
Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.
Time frame: 10 years
Parker Mobility Score
Time frame: 10 years
EQ5D-5L
Time frame: 2 years
Acetabular erosion measured comparing immediate post-operative X-rays (baseline) to 2-year follow up and classified according to the criteria of Baker et al.
Time frame: 2 years
Femoral stem stability measured on weight-bearing AP and lateral X-rays as rate of continuous, progressive and symptomatic periprosthetic radiolucent lines greater than 2mm using the zonal classification described by Gruen et al. from immediate postoperative (baseline) to 2-year follow up.
Time frame: 2 years
Bipolar head migration measured comparing immediate post operative X Rays (baseline) to 2 years
Contact information is provided by the study sponsor or research team.
Corin
Industry
A Post-market Clinical Follow-up (PMCF) Study to Evaluate Clinical, Radiographic and Patient Reported Outcomes Following a Hip Hemiarthroplasty Surgery Using Corin Devices
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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