NCT04872855

Observational Study to Evaluate Clinical Performance and Safety in Total Knee Arthroplasty

Observational Study to Evaluate the Performance and the Safety of the HLS KneeTec Cementless or Hybrid Fixations in Total Knee Arthroplasty

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 163 (actual)
• Sponsor: Corin · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the long-term performance and safety of HLS KneeTec cementless and hybrid fixation knee prosthesis when used in standard medical practice.

Detailed description

It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in French sites where Total Knee Arthroplasty with HLS Kneetec cementless and hybrid fixation knee prosthesis is performed routinely All patients treated with HLS KneeTec (cementless 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. Patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up (FU) visits as following: 4 months (+/- 2 months); 1 year (+/- 2 months); 5 years (+/- 12 months) and 10 years (+/- 12 months).

Conditions

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

Interventions

Type	Name	Description
DEVICE	patient with knee arthroplasty	patient with HLS KneeTec cementless and hybrid fixation prosthesis

Timeline

• Start date: 2020-07-17
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2021-05-05
• Last updated: 2025-02-06

Locations

3 sites across 1 country: France