A Post-market Observational ORIGIN® CR Clinical Study

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR devices and associated instruments. Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months. ;

Study Design

Related Conditions & MeSH terms

Total Knee Replacement

Clinical Trial Details

NCT number	NCT05607966
Study type	Observational
Source	Symbios Orthopedie SA
Contact
Status	Not yet recruiting
Phase
Start date	November 2022
Completion date	June 2027

View Details

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