Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+) | Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolar i and cemented stem (Océane+ or Meije) | Device | Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 years |
| Evaluation of study devices performance and benefit through patient's mobility from baseline to 10-year FU. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa GRIMAUD | Contact | 0667267075 | vanessa.grimaud@coringroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Christophe HULET, MD, PhD | University Hospital, Caen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch Amboise | Recruiting | Amboise | France | 37403 | France |
Not provided
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D015207 | Osteoarthritis, Hip |
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Parker Mobility Score |
| 10 years |
| Evaluation of study devices performance and benefit through patient's quality of life from baseline to 10-year FU. | EQ5D-5L | 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. | 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. | 2 years |
| Radiographic analysis to detect bipolar head migration | Bipolar head migration measured comparing immediate post operative X Rays (baseline) to 2 years | 2 years |
| Polyclinique Henin Beaumont | Terminated | Hénin-Beaumont | 62110 | France |
| Hopital Saint Joseph | Recruiting | Paris | 75014 | France |
|
| Hopital Diaconesses Croix Saint Simon | Not yet recruiting | Paris | 75020 | France |
|
| D007869 |
| Leg Injuries |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |