Avascular Necrosis of Hip, Femoral Neck Fractures, Hip Fractures, Hip Hemiarthroplasty, Osteoarthritis, Hip
Conditions
Keywords
Hemiarthroplasty, Acetabulum, Hip Fractures
Brief 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.
Interventions
DEVICEBipolar i and cemented stem (Océane+ or Meije)
Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint
Sponsors
Corin
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Both genders. 2. Adult subjects. 3. 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. 4. The subject is willing to comply with the required follow-up visits as per protocol. 5. The subject, or a designated trusted person in case the subject is unable to do, has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.
Exclusion criteria
1. Subjects with active infection or sepsis or osteomyelitis. 2. Subjects with unsuitable or insufficient bone support preventing proper fixation of the prosthesis. 3. Subject with marked bone loss or bone absorption. 4. Subject with metabolic disorders which may impair bone formation or bone quality. 5. Subjects under guardianship. 6. Subjects under jusicial protection 7. Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of safety of the study devices at 2 years after a hip hemiarthroplasty surgery. | 2 years | Intraoperative and postoperative adverse events (hip, device or procedure related) will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of mid-term and long-term safety of the study devices up to 10 years. | 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. | 10 years | Parker Mobility Score |
| Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU. | 10 years | EQ5D-5L |
| Radiographic analysis to detect acetabular erosion | 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. |
| Radiographic analysis to detect femoral stem stability | 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. |
| Radiographic analysis to detect bipolar head migration | 2 years | Bipolar head migration measured comparing immediate post operative X Rays (baseline) to 2 years |
Countries
France
Contacts
CONTACTVanessa GRIMAUD
STUDY_CHAIRChristophe HULET, MD, PhD
University Hospital, Caen
Outcome results
None listed