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.
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.
Subjects with active infection or sepsis or osteomyelitis.
Subjects with unsuitable or insufficient bone support preventing proper fixation of the prosthesis.
Subject with marked bone loss or bone absorption.
Subject with metabolic disorders which may impair bone formation or bone quality.
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.
Cohort
Other
Bipolar i and cemented stem (Océane+ or Meije)
DeviceHip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint
Evaluation 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.
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.
Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU.
Parker Mobility Score
Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU.
EQ5D-5L
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.
