NCT05607966

A Post-market Observational ORIGIN® CR Clinical Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 199 (estimated)
• 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® 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.

Detailed 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.

Conditions

• Total Knee Replacement

Interventions

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

Timeline

• Start date: 2024-07-10
• Primary completion: 2027-11-01
• Completion: 2028-02-01
• First posted: 2022-11-07
• Last updated: 2024-10-08

Locations

2 sites across 1 country: Belgium