ROSA Knee Intraoperative Planning Flexibility Study (IntraOP)

Zimmer Biomet

Status: Enrolling

Conditions: Rheumatoid Arthritis; Osteo Arthritis Knee

Treatments: Device: Total Knee Replacement (TKR)

Study type: Observational

Funder types: Industry

Identifiers

NCT05966519

CSA2022-29TDS

Details and patient eligibility

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.

Full description

The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique.

The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan & intra-op final plan.

The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.

Enrollment: 80 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

TKA with ROSA Knee

Description:

Total Knee Arthroplasty (TKA) is conducted using with robotic surgical assistant (ROSA) system

Treatment:

Device: Total Knee Replacement (TKR)