Ireland
--:--IST
Recruiting Observational

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

NCT05044767 · tracked via the Priya Life Science France tracker
Sponsor
ATF Implants
Phase
Observational
Started
2021-06-07
Last updated
2023-02-01

Condition(s) studied

Arthroplasty, Hip, Replacement

Investigational drug(s) / intervention(s)

total hip arthroplasty

total hip arthroplasty: hip replacement surgery

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Long-term survival rate — 10 years
    Long-term survival rate of the prostheses (10 years) with failure defined as revision surgery when considering all causes using Kaplan-Meier method.

Trial sites (13)

FacilityCityRegionStatus
CHU de Bordeaux - Hôpital Pellegrin Bordeaux France Not Yet Recruiting
Clinique des Cèdres Cornebarrieu France Not Yet Recruiting
Centre Ostéo-Articulaire des Cèdres Échirolles France Recruiting
Hôpital privé Drôme Ardèche Guilherand-Granges France Not Yet Recruiting
Clinique du Croisé Laroche Marcq-en-Barœul France Recruiting
Polyclinique Saint George Nice France Not Yet Recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon Paris France Recruiting
CHU de Poitiers Poitiers France Recruiting
Clinique de l'Atlantique Puilboreau France Not Yet Recruiting
CHU St Etienne, Hôpital Nord Saint-Etienne France Not Yet Recruiting
Polyclinique Sainte Thérèse Sète France Recruiting
Clinique de l'Orangerie Strasbourg France Recruiting
Hôpital privé du Vert Galant Tremblay-en-France France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05044767 on ClinicalTrials.gov ↗ ← All trials in France