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出境医 / 临床实验 / ROSA Robot Used in Total Knee Replacement Post Market Study

ROSA Robot Used in Total Knee Replacement Post Market Study

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.

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
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, New Jersey
Rothman Orthopaedics
Montvale, New Jersey, United States, 07645
United States, Virginia
OrthoVirginia Chippenham
North Chesterfield, Virginia, United States, 23225
Sponsors and Collaborators
Zimmer Biomet
Investigators
Layout table for investigator information
Study Director: Kacy Arnold Zimmer Biomet
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • EQ-5D questionnaire [ Time Frame: 1 year ]
  • Oxford Knee Score [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ROSA Robot Used in Total Knee Replacement Post Market Study
Official Title  ICMJE ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Pain
  • Chronic Osteoarthritis
  • Avascular Necrosis of the Femoral Condyle
  • Moderate Varus, Valgus or Flexion Deformities
  • Rheumatoid Arthritis
Intervention  ICMJE
  • Device: PERSONA Total Knee
    Primary Total Knee Arthroplasty
  • Device: Vanguard Total Knee
    Primary Total Knee Arthroplasty
  • Device: NexGen Total Knee
    Primary Total Knee Arthroplasty
Study Arms  ICMJE
  • Active Comparator: Robotic Assisted TKA
    Robotic Assisted TKA
    Interventions:
    • Device: PERSONA Total Knee
    • Device: Vanguard Total Knee
    • Device: NexGen Total Knee
  • Active Comparator: Conventional TKA
    Conventional TKA
    Interventions:
    • Device: PERSONA Total Knee
    • Device: Vanguard Total Knee
    • Device: NexGen Total Knee
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 6, 2020) 		300
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2019) 		240
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969654
Other Study ID Numbers  ICMJE CMU2018-34K
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kacy Arnold Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP