NCT06628050

ORIGIN® PS Modular & Associated Instruments

Post-market Observational Study of the ORIGIN® PS Modular Total Knee Prosthesis and Associated Instruments

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Symbios Orthopedie SA · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is ambispective, post market, non-comparative, non-randomized, multicentric and observational in which 200 patients will be enrolled to evaluate the safety and performance of the ORIGIN® PS Modular devices and associated instruments. Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.

Conditions

• Total Knee Replacement

Interventions

Type	Name	Description
DEVICE	ORIGIN® PS Modular devices	Consecutive eligible subjects have been included which have been treated with the ORIGIN® PS Modular devices.

Timeline

• Start date: 2023-04-18
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2024-10-04
• Last updated: 2024-10-04

Locations

2 sites across 1 country: France