ROSA Knee Intraoperative Planning Flexibility Study
Recruiting · NCT05966519 · Observational (researchers observe without assigning treatment) · Lead sponsor: Zimmer Biomet
View the official record on ClinicalTrials.gov →Interventions studied
Total Knee Replacement (TKR)
What this trial is about
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.
Who can take part
Age range
20 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Kyushu University Hospital - Fukuoka, Fukuoka, Japan