NCT05044767

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

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,500 (estimated)
• Sponsor: ATF Implants · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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 or hemiarthroplasty. The post-market clinical follow-up study to be conducted by ATF Implants following this plan aims to collect data from the follow-up of patients before and after hip replacement surgery with implants manufactured by ATF Implants and Lapé médical. In current practice, the surgeon-investigator evaluates the patient pre- and post-operatively according to predefined criteria used in orthopedic surgery and more particularly in hp replacement surgery. Complications and adverse effects observed are also recorded. The main objective is to gather clinical evidence to evaluate the survival rate of ATP Implants and Lapé médical hip prostheses over the long-term, namely 10 years. The secondary objectives are to evaluate the performance and safety of the prostheses over the same period (i.e. 10 years), as well as to obtain feedback on the performance /intended use and safety of the surgical instruments required for implant placement.

Conditions

• Arthroplasty, Hip, Replacement

Interventions

Type	Name	Description
DEVICE	total hip arthroplasty	hip replacement surgery

Timeline

• Start date: 2021-06-07
• Primary completion: 2032-12-31
• Completion: 2032-12-31
• First posted: 2021-09-16
• Last updated: 2023-02-01

Locations

13 sites across 1 country: France