ROSA Robot Used in Total Knee Replacement Post Market Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kacy Arnold
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Enrolling by invitation
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
Additional Details

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.#46;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.

Arms & Interventions


Active Comparator: Robotic Assisted TKA

Robotic Assisted TKA

Active Comparator: Conventional TKA

Conventional TKA


Device: - PERSONA Total Knee

Primary Total Knee Arthroplasty

Device: - Vanguard Total Knee

Primary Total Knee Arthroplasty

Device: - NexGen Total Knee

Primary Total Knee Arthroplasty

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vail-Summit Orthopaedics, Vail, Colorado



Vail-Summit Orthopaedics

Vail, Colorado, 81657

Westminster, Colorado



Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC

Westminster, Colorado, 80023

SIU School of Medicine, Springfield, Illinois



SIU School of Medicine

Springfield, Illinois, 62702

Henry Ford Health System, Detroit, Michigan



Henry Ford Health System

Detroit, Michigan, 48202

Rothman Orthopaedics, Montvale, New Jersey



Rothman Orthopaedics

Montvale, New Jersey, 07645

OrthoVirginia Chippenham, North Chesterfield, Virginia



OrthoVirginia Chippenham

North Chesterfield, Virginia, 23225