Clinical Research Directory
Browse clinical research sites, groups, and studies.
ORIGIN® PS Modular & Associated Instruments
Sponsor: Symbios Orthopedie SA
Summary
The study objective is to evaluate safety and performance of the ORIGIN® PS (postero-stabilized) Modular devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 2-6 months, 1y and 2y post-procedure and to evaluate performance by means of a Knee Society Score (KSS) Score at 2-6 months, 1y and 2y post procedure. The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® PS Modular.
Official title: Post-market Observational Study of the ORIGIN® PS Modular Total Knee Prosthesis and Associated Instruments
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2023-04-18
Completion Date
2025-09
Last Updated
2024-10-04
Healthy Volunteers
No
Conditions
Interventions
ORIGIN® PS Modular devices
Consecutive eligible subjects have been included which have been treated with the ORIGIN® PS Modular devices.
Locations (2)
Polyclinique Medipole Saint Roch
Cabestany, France
Clinique Juge
Marseille, France