ROSA Knee Intraoperative Planning Flexibility Study

NCT05966519 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Total Knee Replacement (TKR)

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

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Yasuharu Nakashima · Kyushu University

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2027-01-31
Completion
2029-01-31
FDA Device
Yes

Countries

  • Japan

Study Locations

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Entities

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 NCT05966519 on ClinicalTrials.gov