RecruitingNCT05966519

ROSA Knee Intraoperative Planning Flexibility Study

ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, A Single Center Prospective Study


Sponsor

Zimmer Biomet

Enrollment

80 participants

Start Date

Jan 5, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting data on the ROSA Knee System — a robotic arm that assists surgeons during total knee replacement surgery — to evaluate how using real-time intraoperative data and planning flexibility affects surgical and patient outcomes. **You may be eligible if...** - You are 20 years or older and skeletally mature (bones fully developed) - You and your doctor have already independently decided you need a total knee replacement using the ROSA Knee robotic system - You are willing and able to attend all scheduled follow-up visits - You have signed an approved informed consent form **You may NOT be eligible if...** - You have serious bone damage, severe osteoporosis, or conditions that make knee replacement unsafe - You have an active infection - You are unable to commit to follow-up visits - You have other conditions that your surgeon determines would make participation unsafe 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

DEVICETotal Knee Replacement (TKR)

Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses


Locations(1)

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

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NCT05966519


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