NCT04727060

Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty

A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2,146 (actual)
• Sponsor: Corin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

Detailed description

It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely. All patients treated with HLS KneeTec (cemented, non-cemented or hybrid versions) implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study. Data will be collected retrospectively for HLS I, II, Evolution and Noetos® implants, and when prospectively for cementless, cemented and hybrid HLS KneeTec prosthesis. Post-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y FU visits per protocol then up to the latest FU visit available.

Conditions

• Total Knee Arthroplasty
• Knee Disease
• Total Knee Replacement
• Osteo Arthritis Knee

Interventions

Type	Name	Description
DEVICE	patient with knee arthroplasty

Timeline

• Start date: 2011-12-15
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2021-01-27
• Last updated: 2024-07-16

Locations

1 site across 1 country: France