Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Impl
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.
| Condition(s) | Arthroplasty, Hip, Replacement |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 accordin |
| Sex | All |
| Lead sponsor | ATF Implants |
| Locations | Bordeaux, France; Cornebarrieu, France; Échirolles, France; Guilherand-Granges, France; Marcq-en-Barœul, France; Nice, France (+7 more sites) |
| Start date | 2021-06-07 |
| NCT ID | NCT05044767 |
| Official listing | https://clinicaltrials.gov/study/NCT05044767 |