RecruitingNCT05607966

A Post-market Observational ORIGIN® CR Clinical Study


Sponsor

Symbios Orthopedie SA

Enrollment

199 participants

Start Date

Jul 10, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study follows patients who receive the ORIGIN CR total knee replacement implant to monitor outcomes over time in a real-world setting. Researchers want to confirm the implant's safety, durability, and patient satisfaction at 1 and 2 years after surgery. You may be eligible if: - You are 18 or older - You have a clinical indication for a total knee replacement - You are willing to return for follow-up visits at 1 and 2 years - If female, you are not pregnant and not planning pregnancy within 12 months You may NOT be eligible if: - You have a current local or systemic infection - You have significant muscle, ligament, nerve, psychological, or vascular problems - You have poor bone quality or bone destruction that would require a more complex implant - You have an allergy or sensitivity to any implant materials - You have significant knee deformity (HKA angle outside 165°-195°, severe ligament deficiency, or posterior cruciate ligament deficiency) - You have a prior partial or total knee prosthesis requiring revision - You have non-extractable hardware that would conflict with the implant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEORIGIN® 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

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NCT05607966


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