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A Post-market Observational ORIGIN® CR Clinical Study
Sponsor: Symbios Orthopedie SA
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
Conditions
Interventions
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