Back to resultsROSA Total Knee Investigational Testing Authorization Study
Primary Purpose
Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of Femoral Condyle
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PERSONA Total Knee
Sponsored by
About this trial
This is an interventional treatment trial for Knee Pain
Eligibility Criteria
Inclusion Criteria:
- 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
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
Sites / Locations
- Hôpital Maisonneuve-Rosemont
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Robotic Assisted TKA
Conventional TKA
Arm Description
Robotic Assisted TKA via ROSA Robot
Conventional TKA
Outcomes
Primary Outcome Measures
EQ-5D questionnaire
EQ-5D
Oxford Knee Score Questionnaire
Oxford Knee Score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03970629
Brief Title
ROSA Total Knee Investigational Testing Authorization Study
Official Title
ROSA Total Knee Investigational Testing Authorization Study: Prospective Single Center Study of the ROSA Total Knee System
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Challenging enrollment due to COVID-19.
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of Femoral Condyle, Moderate Varus, Valgus or Flexion Deformities, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic Assisted TKA
Arm Type
Active Comparator
Arm Description
Robotic Assisted TKA via ROSA Robot
Arm Title
Conventional TKA
Arm Type
Active Comparator
Arm Description
Conventional TKA
Intervention Type
Device
Intervention Name(s)
PERSONA Total Knee
Intervention Description
Primary Total Knee Arthroplasty
Primary Outcome Measure Information:
Title
EQ-5D questionnaire
Description
EQ-5D
Time Frame
1 year
Title
Oxford Knee Score Questionnaire
Description
Oxford Knee Score
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Jaggard
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ROSA Total Knee Investigational Testing Authorization Study
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