ROSA Robot Used in Total Knee Replacement Post Market Study

Zimmer Biomet

Status

Completed

Conditions

Avascular Necrosis of the Femoral Condyle

Moderate Varus, Valgus or Flexion Deformities

Chronic Osteoarthritis

Rheumatoid Arthritis

Knee Pain

Treatments

Device: NexGen Total Knee

Device: Vanguard Total Knee

Device: PERSONA Total Knee

Study type

Interventional

Funder types

Industry

Identifiers

NCT03969654

CMU2018-34K

Details and patient eligibility

About

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.

Full description

The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Enrollment

181 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patient is a minimum of 18 years of age
Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and Vanguard knee components implanted in accordance with product labeling
Patient has participated in this study-related Informed Consent process
Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form
Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion criteria

Patient is currently participating in any other surgical intervention studies or pain management studies
Patient has underwent contralateral UKA or TKA within the last 18 months
Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)
Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Patient has previously received partial or total knee arthroplasty for the ipsilateral knee