ROSA Knee Intraoperative Planning Flexibility Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorZimmer Biomet
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Total Knee Replacement (TKR)
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov