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ROSA Knee Intraoperative Planning Flexibility Study

RecruitingN/A

Sponsor: Zimmer Biomet

Conditions: Osteo Arthritis Knee, Rheumatoid Arthritis

Interventions: Total Knee Replacement (TKR)

Countries: Japan

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 overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Fukuoka, Fukuoka, Japan