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ROSA Robot Used in Total Knee Replacement Post Market Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969654
Recruitment Status : Active, not recruiting
First Posted : May 31, 2019
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment Phase
Knee Pain Chronic Osteoarthritis Avascular Necrosis of the Femoral Condyle Moderate Varus, Valgus or Flexion Deformities Rheumatoid Arthritis Device: PERSONA Total Knee Device: Vanguard Total Knee Device: NexGen Total Knee Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Active Comparator: Robotic Assisted TKA
Robotic Assisted TKA
Device: PERSONA Total Knee
Primary Total Knee Arthroplasty

Device: Vanguard Total Knee
Primary Total Knee Arthroplasty

Device: NexGen Total Knee
Primary Total Knee Arthroplasty

Active Comparator: Conventional TKA
Conventional TKA
Device: PERSONA Total Knee
Primary Total Knee Arthroplasty

Device: Vanguard Total Knee
Primary Total Knee Arthroplasty

Device: NexGen Total Knee
Primary Total Knee Arthroplasty




Primary Outcome Measures :
  1. 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.


  2. Workflow Efficiency [ Time Frame: 1 year ]

    Intraoperative questionnaire detailing surgical and OR efficiencies.

    • Operative Time
    • Tourniquet Time
    • Personnel involved/present in OR
    • Knee Alignment Values



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969654


Locations
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United States, Colorado
Vail-Summit Orthopaedics
Vail, Colorado, United States, 81657
Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC
Westminster, Colorado, United States, 80023
United States, Illinois
SIU School of Medicine
Springfield, Illinois, United States, 62702
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Virginia
OrthoVirginia Chippenham
North Chesterfield, Virginia, United States, 23225
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold Zimmer Biomet
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03969654    
Other Study ID Numbers: CMU2018-34K
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Necrosis
Pathologic Processes