- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03969654
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Robotic Assisted TKA
|
Primary Total Knee Arthroplasty
Primary Total Knee Arthroplasty
Primary Total Knee Arthroplasty
|
Active Comparator: Conventional TKA
|
Primary Total Knee Arthroplasty
Primary Total Knee Arthroplasty
Primary Total Knee Arthroplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Performance
Time Frame: 1 year
|
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. |
1 year
|
Workflow Efficiency
Time Frame: 1 year
|
Intraoperative questionnaire detailing surgical and OR efficiencies.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hillary Overholser, Zimmer Biomet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMU2018-34K
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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