ROSA Total Knee Investigational Testing Authorization Study

NCT03970629 | Terminated

• 1 other identifier: CEU2018-46K
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• EQ-5D questionnaire

  EQ-5D

  1 year

• Oxford Knee Score Questionnaire

  Oxford Knee Score

  1 year

Study Arms (2)

Robotic Assisted TKA

ACTIVE COMPARATOR

Robotic Assisted TKA via ROSA Robot

Device: PERSONA Total Knee

Conventional TKA

ACTIVE COMPARATOR

Conventional TKA

Device: PERSONA Total Knee

Interventions

PERSONA Total Knee DEVICE

Primary Total Knee Arthroplasty

Conventional TKA; Robotic Assisted TKA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is a minimum of 18 years of age
• Pre-op component positioning and sizing plan prior to surgery
• Independent of study participation, patient is a candidate for primary TKA using the commercially available Persona 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Genu Valgum; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Charles Jaggard

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: May 31, 2019
• Study Start: June 20, 2019
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)