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Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
The post-market clinical follow-up study to be conducted by ATF Implants following this plan aims to collect data from the follow-up of patients before and after hip replacement surgery with implants manufactured by ATF Implants and Lapé médical. In current practice, the surgeon-investigator evaluates the patient pre- and post-operatively according to predefined criteria used in orthopedic surgery and more particularly in hp replacement surgery. Complications and adverse effects observed are also recorded.
The main objective is to gather clinical evidence to evaluate the survival rate of ATP Implants and Lapé médical hip prostheses over the long-term, namely 10 years.
The secondary objectives are to evaluate the performance and safety of the prostheses over the same period (i.e. 10 years), as well as to obtain feedback on the performance /intended use and safety of the surgical instruments required for implant placement.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total hip arthroplasty | Device | hip replacement surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term survival rate | Long-term survival rate of the prostheses (10 years) with failure defined as revision surgery when considering all causes using Kaplan-Meier method. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| hip joint function | The evolution of hip joint function, and in this case the degree of physical disability before and after an intervention with Merle d'Aubigné score (PMA score) or Harris Hip Score (HHS score) or Parker score | before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years) |
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Inclusion Criteria:
There are different indications for hip replacement surgery. The main ones are listed below:
Depending on the specificities of the devices (size, absence/presence of a coating, material), indications may vary. This information can be found in the instruction for use. It is the surgeon's responsibility to select the most appropriate prosthesis for a given patient according to the patient's medical records and the instruction for use in force at the time of the procedure accompanying the medical device.
Exclusion Criteria:
There are various contraindications for hip arthroplasty. The main ones are listed below:
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Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Laffargue, Pr | Contact | 891650494 | +33 | plaffargue@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Laffargue, Pr | Clinique du Croisé Laroche | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Hôpital Pellegrin | Not yet recruiting | Bordeaux | 33076 | France |
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| Clinique des Cèdres | Not yet recruiting | Cornebarrieu | 31700 | France |
|
| Centre Ostéo-Articulaire des Cèdres | Recruiting | Échirolles | 38130 | France |
|
| Hôpital privé Drôme Ardèche | Not yet recruiting | Guilherand-Granges | 07500 | France |
|
| Clinique du Croisé Laroche | Recruiting | Marcq-en-Barœul | 59700 | France |
|
| Polyclinique Saint George | Not yet recruiting | Nice | 06100 | France |
|
| Groupe Hospitalier Diaconesses Croix Saint-Simon | Recruiting | Paris | 75020 | France |
|
| CHU de Poitiers | Recruiting | Poitiers | 86000 | France |
|
| Clinique de l'Atlantique | Not yet recruiting | Puilboreau | 17138 | France |
|
| CHU St Etienne, Hôpital Nord | Not yet recruiting | Saint-Etienne | 42055 | France |
|
| Polyclinique Sainte Thérèse | Recruiting | Sète | 34200 | France |
|
| Clinique de l'Orangerie | Recruiting | Strasbourg | 67000 | France |
|
| Hôpital privé du Vert Galant | Not yet recruiting | Tremblay-en-France | 93290 | France |
|
| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| D062785 | Hemiarthroplasty |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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