ROSA Knee Intraoperative Planning Flexibility on Japan Preferred Surgical Technique, a Single Center Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Japan
Kyushu University Hospital
RECRUITING
Fukuoka
Contact Information
Primary
Noriko Sugawara
noriko.sugawara@zimmerbiomet.com
+81-3-6402-6600
Time Frame
Start Date: 2024-01-05
Estimated Completion Date: 2028-01
Participants
Target number of participants: 80
Treatments
TKA with ROSA Knee
Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system
Sponsors
Leads: Zimmer Biomet

This content was sourced from clinicaltrials.gov