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.
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveCohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 7 juin 2021
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.4500 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Inclusion Criteria: * Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical; There are different indications for hip replacement surgery. The main ones are listed below: * Dysplasia * Primary Coxarthrosis * Secondary Coxarthrosis * Perthes disease * Epiphysiolysis * Ankylosing spondylitis * Trochanteric bursitis * Arthritis * Degenerative arthritis * Post-traumatic arthritis * Rheumatoid arthritis * Femoral neck fracture * Osteonecrosis * Revision 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: * An acute or chronic, local or systemic infection * Severe muscular, neurological or vascular deficiency compromising the affected extremity * A bone defect or insufficient bone quality that may compromise the stability of the implant * Any concomitant disease (dysplastic coxarthrosis with extreme coxa valga, short neck and severe varus) that may affect the function of the implant * Sensitivity to the material (allergy) Depending on the specificities of the devices (size, absence/presence of a coating, material), contraindications may vary. This information can be found in the instruction for use of the devices.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 13 sites
Centre Ostéo-Articulaire des Cèdres
Échirolles, FranceOuvrir Centre Ostéo-Articulaire des Cèdres dans Google MapsClinique du Croisé Laroche
Marcq-en-Barœul, FranceGroupe Hospitalier Diaconesses Croix Saint-Simon
Paris, FranceCHU de Poitiers
Poitiers, France