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.
Study Type
OBSERVATIONAL
Enrollment
4,500
hip replacement surgery
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
NOT_YET_RECRUITINGClinique des Cèdres
Cornebarrieu, France
NOT_YET_RECRUITINGLong-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.
Time frame: 10 years
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
Time frame: before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years)
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Centre Ostéo-Articulaire des Cèdres
Échirolles, France
RECRUITINGHôpital privé Drôme Ardèche
Guilherand-Granges, France
NOT_YET_RECRUITINGClinique du Croisé Laroche
Marcq-en-Barœul, France
RECRUITINGPolyclinique Saint George
Nice, France
NOT_YET_RECRUITINGGroupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France
RECRUITINGCHU de Poitiers
Poitiers, France
RECRUITINGClinique de l'Atlantique
Puilboreau, France
NOT_YET_RECRUITINGCHU St Etienne, Hôpital Nord
Saint-Etienne, France
NOT_YET_RECRUITING...and 3 more locations