Back to resultsROSA Robot Used in Total Knee Replacement Post Market Study
Primary Purpose
Knee Pain, Chronic Osteoarthritis, Avascular Necrosis of the Femoral Condyle
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PERSONA Total Knee
Vanguard Total Knee
NexGen 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
- 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
Sites / Locations
- Vail-Summit Orthopaedics
- Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC
- SIU School of Medicine
- Henry Ford Health System
- OrthoVirginia Chippenham
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
Conventional TKA
Outcomes
Primary Outcome Measures
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.
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 and the maximum score is 48 points.
Workflow Efficiency
Intraoperative questionnaire detailing surgical and OR efficiencies.
Operative Time
Tourniquet Time
Personnel involved/present in OR
Knee Alignment Values
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03969654
Brief Title
ROSA Robot Used in Total Knee Replacement Post Market Study
Official Title
ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
September 22, 2023 (Actual)
Study Completion Date
September 22, 2023 (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
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
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 the 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
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic Assisted TKA
Arm Type
Active Comparator
Arm Description
Robotic Assisted TKA
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
Intervention Type
Device
Intervention Name(s)
Vanguard Total Knee
Intervention Description
Primary Total Knee Arthroplasty
Intervention Type
Device
Intervention Name(s)
NexGen Total Knee
Intervention Description
Primary Total Knee Arthroplasty
Primary Outcome Measure Information:
Title
Clinical Performance
Description
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.
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 and the maximum score is 48 points.
Time Frame
1 year
Title
Workflow Efficiency
Description
Intraoperative questionnaire detailing surgical and OR efficiencies.
Operative Time
Tourniquet Time
Personnel involved/present in OR
Knee Alignment Values
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Overholser
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Vail-Summit Orthopaedics
City
Vail
State/Province
Colorado
ZIP/Postal Code
81657
Country
United States
Facility Name
Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80023
Country
United States
Facility Name
SIU School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
OrthoVirginia Chippenham
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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ROSA Robot Used in Total Knee Replacement Post Market Study
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