ROSA Robot Used in Total Knee Replacement Post Market Study

ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Knee Pain; Chronic Osteoarthritis; Avascular Necrosis of the Femoral Condyle; Moderate Varus, Valgus or Flexion Deformities
• Intervention / Treatment: Device: PERSONA Total Knee; Device: Vanguard Total Knee; Device: NexGen Total Knee

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Vail, Colorado, United States, 81657
      • Vail-Summit Orthopaedics
    • Westminster, Colorado, United States, 80023
      • Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC
  • Illinois
    • Springfield, Illinois, United States, 62702
      • SIU School of Medicine
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Virginia
    • North Chesterfield, Virginia, United States, 23225
      • OrthoVirginia Chippenham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Robotic Assisted 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
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Performance	EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.	Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Oxford	Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).	Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Post-Operative Pain & Satisfaction	Post-Operative Pain & Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.	6 weeks, 3 months, and 1 year
Total Range of Motion	Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop	Pre-op (Baseline), 6 weeks, 3 months, and 1 year

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hillary Overholser, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): September 22, 2023

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: CMU2018-34K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes