ROSA Total Knee Investigational Testing Authorization Study

ROSA Total Knee Investigational Testing Authorization Study: Prospective Single Center Study of the ROSA Total Knee System

This is a prospective, single-center 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 Total Knee components using the ROSA Total Knee Robotic System or conventional instrumentation.

Study Overview

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

Detailed Description

The primary objective of this study is to collect and compare clinical outcomes and surgical data using the ROSA Total Knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty.

The assessments will include: Planned vs actual component positioning; Workflow efficiency; Patient safety based on incidence and frequency of adverse events; Clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is a minimum of 18 years of age
2. Pre-op component positioning and sizing plan prior to surgery
3. Independent of study participation, patient is a candidate for primary TKA using the commercially available Persona knee components implanted in accordance with product labeling
4. Patient has participated in this study-related Informed Consent process
5. Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form
6. Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion Criteria:

1. Patient is currently participating in any other surgical intervention studies or pain management studies
2. Patient has underwent contralateral UKA or TKA within the last 18 months
3. 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)
4. Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)
5. Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
6. 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
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Robotic Assisted TKA; Robotic Assisted TKA via ROSA Robot	Device: PERSONA Total Knee; Primary Total Knee Arthroplasty
ACTIVE_COMPARATOR: Conventional TKA	Device: PERSONA Total Knee; Primary Total Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D questionnaire	EQ-5D	1 year
Oxford Knee Score Questionnaire	Oxford Knee Score	1 year

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2019
• Primary Completion (ACTUAL): November 23, 2021
• Study Completion (ACTUAL): November 23, 2021

Study Registration Dates

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

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: CEU2018-46K

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: No