Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty

Recruiting now

Conditions studied: Arthroplasty, Hip, Replacement

In brief

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.

Key facts

Study ID

NCT05044767

Run by

ATF Implants

People needed

4500

Starts

2021-06-07

Expected to finish

2032-12-31

Last updated by the study team

2023-02-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CHU de Poitiers — Poitiers, France (enrolling)
• Clinique du Croisé Laroche — Marcq-en-Barœul, France (enrolling)
• Centre Ostéo-Articulaire des Cèdres — Échirolles, France (enrolling)
• Polyclinique Sainte Thérèse — Sète, France (enrolling)
• Clinique de l'Orangerie — Strasbourg, France (enrolling)
• Groupe Hospitalier Diaconesses Croix Saint-Simon — Paris, France (enrolling)
• CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France
• Hôpital privé du Vert Galant — Tremblay-en-France, France
• Clinique des Cèdres — Cornebarrieu, France
• Hôpital privé Drôme Ardèche — Guilherand-Granges, France
• Polyclinique Saint George — Nice, France
• Clinique de l'Atlantique — Puilboreau, France
• CHU St Etienne, Hôpital Nord — Saint-Etienne, France

Full record on ClinicalTrials.gov

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