Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05607966

A Post-market Observational ORIGIN® CR Clinical Study

Sponsor: Symbios Orthopedie SA

View on ClinicalTrials.gov

Summary

The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year 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® CR.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

199

Start Date

2024-07-10

Completion Date

2028-02

Last Updated

2024-10-08

Healthy Volunteers

No

Interventions

DEVICE

ORIGIN® CR devices

It is planned to include consecutive eligible subjects which will be treated with the ORIGIN® CR devices.

Locations (2)

GZA Ziekenhuizen - campus Sint-Augustinus

Antwerp, Belgium

AZ Voorkempen

Malle, Belgium