Status:
RECRUITING
Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty
Lead Sponsor:
ATF Implants
Conditions:
Arthroplasty, Hip, Replacement
Eligibility:
All Genders
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
4500 Patients enrolled
Trial Details
Trial ID
NCT05044767
Start Date
June 7 2021
End Date
December 31 2032
Last Update
February 1 2023
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33076
2
Clinique des Cèdres
Cornebarrieu, France, 31700
3
Centre Ostéo-Articulaire des Cèdres
Échirolles, France, 38130
4
Hôpital privé Drôme Ardèche
Guilherand-Granges, France, 07500