Informations générales (source: ClinicalTrials.gov)
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 [Patient Registry]
ATF Implants (Voir sur ClinicalTrials)
juin 2021
décembre 2032
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Simon Marmor | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Ostéo-Articulaire des Cèdres - 38130 - Échirolles - France | Jean-Claude Panisset | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - Hôpital Pellegrin - 33076 - Bordeaux - France | Vincent Souillac | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - 86000 - Poitiers - France | Pierre Bouget | Contact (sur clinicalTrials) | |||
| CHU St Etienne, Hôpital Nord - 42055 - Saint-Étienne - France | Frédéric Farizon | Contact (sur clinicalTrials) | |||
| Clinique de l'Atlantique - 17138 - Puilboreau - France | Cédric Bouquet | Contact (sur clinicalTrials) | |||
| Clinique de l'Orangerie - 67000 - Strasbourg - France | David Dagrenat | Contact (sur clinicalTrials) | |||
| Clinique des Cèdres - 31700 - Cornebarrieu - France | Jonathan Hourtal | Contact (sur clinicalTrials) | |||
| Clinique du Croisé Laroche - 59700 - Marcq-en-Barœul - France | Philippe Laffargue | Contact (sur clinicalTrials) | |||
| Hôpital privé Drôme Ardèche - 07500 - Guilherand-Granges - France | Richard Philippe | Contact (sur clinicalTrials) | |||
| Hôpital privé du Vert Galant - 93290 - Tremblay-en-France - France | Faouzi Madi | Contact (sur clinicalTrials) | |||
| Polyclinique Saint George - 06100 - Nice - France | Hervé Ovadia | Contact (sur clinicalTrials) | |||
| Polyclinique Sainte Thérèse - 34200 - Sète - France | François Lozach | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.