Clinical Trials in France / NCT05044767
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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