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A Post-market Observational ORIGIN® CR Clinical Study

NCT05607966 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 199

Last updated 2024-10-08

No results posted yet for this study

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.

Conditions

  • Total Knee Replacement

Interventions

DEVICE

ORIGIN® CR devices

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

Sponsors & Collaborators

  • Symbios Orthopedie SA

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2027-11-30
Completion
2028-02-29

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05607966 on ClinicalTrials.gov