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Clinical Trials in Japan / NCT05966519
Recruiting Observational

ROSA Knee Intraoperative Planning Flexibility Study

NCT05966519 · tracked via the Priya Life Science Japan tracker
Sponsor
Zimmer Biomet
Phase
Observational
Started
2024-01-05
Last updated
2026-04-08

Condition(s) studied

Osteo Arthritis KneeRheumatoid Arthritis

Investigational drug(s) / intervention(s)

Total Knee Replacement (TKR)

Total Knee Replacement (TKR): Damaged cartilage of knee due to degenerative disease is replaced with metallic and plastic protheses

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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 20 years and over * Skeletally matured * Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study * Willing and able to complete scheduled follow-up evaluations as described in the study protocol * Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form Exclusion Criteria: * Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft * Is septic, has an active infection or has osteomyelitis at the affected joint * Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery * Has any concomitant disease which is likely to jeopardize the functioning or success of the implant * Is known to be pregnant * Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails * Has a known sensitivity or allergy to one or more of the implanted materials

Primary outcome measure(s)

  • The mean absolute difference between X-Atlas image based pre-op plan & intra-op final plan — Immediate post-operative
    The mean absolute difference between X-Atlas image-based pre-op plan and intra-op final plan in order to demonstrate the ability of the system to allow for intra-operative adjustments

Trial sites (1)

FacilityCityRegionStatus
Kyushu University Hospital Fukuoka Fukuoka Recruiting

More Zimmer Biomet trials in Japan

Zimmer Biomet Shoulder Arthroplasty PMCF Recruiting
DenCT Shoulder Bone Quality Evaluation Starting soon
Avenir Complete Post-Market Clinical Follow-Up Study Active, not recruiting

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Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis Recruiting
A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05966519 on ClinicalTrials.gov ↗ ← All trials in Japan