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ACTIVE NOT RECRUITING
NCT06628050

ORIGIN® PS Modular & Associated Instruments

Sponsor: Symbios Orthopedie SA

View on ClinicalTrials.gov

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

Interventions

DEVICE

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