About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Bipolar i and cemented stem (Océane+ or Meije)

Treatment groups

368 Participants
are divided into 1 treatment group

Locations

4
Ch Amboise37403, AmboiseFrance, France
Polyclinique Henin Beaumont62110, Hénin-Beaumont France
Hopital Diaconesses Croix Saint Simon75020, Paris France
Hopital Saint Joseph75014, Paris France

Sponsors and collaborators

Corin

Lead sponsor