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.
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.
Study Type
OBSERVATIONAL
Enrollment
368
Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint
Ch Amboise
Amboise, France
NOT_YET_RECRUITINGPolyclinique Henin Beaumont
Hénin-Beaumont, France
NOT_YET_RECRUITINGHopital Saint Joseph
Paris, France
RECRUITINGEvaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery.
Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.
Time frame: 2 years
Evaluation of mid-term and long-term safety of the study devices up to 10 years.
Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded.
Time frame: 10 years
Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.
Parker Mobility Score
Time frame: 10 years
Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.
EQ5D-5L
Time frame: 10 years
Radiographic analysis to detect acetabular erosion
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
Radiographic analysis to detect femoral stem stability
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
Radiographic analysis to detect bipolar head migration
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Bipolar head migration measured comparing immediate post operative X Rays (baseline) to 2 years
Time frame: 2 years