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Navio Robotic Versus Conventional Total Knee Arthroplasty

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03519269
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Herbert John Cooper, MD, Columbia University

Brief Summary:
Total knee replacement surgery is a conventional approach to alleviating the pain and lack of function resulting from arthritis of the knee. While conventional knee replacement surgery is highly successful, incidences of improperly installed replacement parts are not uncommon. To improve outcomes, robotic-assisted total knee replacement surgery has recently become available, and has been shown to be extremely effective for partial knee replacement surgery. However, further research is needed to determine if this same technology can be equally effective for total knee replacement surgery. The present study will evaluate outcomes of robotic-assisted versus conventional total knee replacement surgery in patients between 40 and 85 years old with end stage arthritis of the knee. Other than surgical technique, patients will receive the same operative care and knee replacement implants. In addition to standard x-rays, subjects will be asked to complete several short-term clinical and functional tests and questionnaires to determine outcomes of their surgery.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Navio™ Robotics-assisted Surgical System Not Applicable

Detailed Description:
Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific. Despite continued improvement in manual instrumentation, postoperative malalignment is still reported in a significant number of patients when these manual instruments are used. Robotic-assisted TKA was developed specifically to improve surgical accuracy, and has been shown to significantly improve accuracy of alignment and joint-line restoration. However, these improvements came at the cost of higher complication rates and were not shown to translate into meaningful clinical outcomes with these first-generation systems. Newer-generation robotic technology offers several advantages over earlier versions including the potential to dynamically assess soft tissues over a range of motion and the ability to use haptic control in bone preparation. Modern robotic-assisted knee surgery has also demonstrated superior outcomes over conventional instrumentation in unicompartmental knee arthroplasty (UKA). This newer-generation of robotic technology, which has quickly become the standard-of-care for many knee surgeons who perform UKA, has recently been approved by the United States Food and Drug Administration (FDA) for use in TKA. Prior to consideration of widespread adoption of this newer technology in patients undergoing TKA, well-designed clinical trials are necessary to study its efficacy in this population. The proposed study evaluates the efficacy of robotic-assistance in patients between 40 and 85 years old with end-stage knee osteoarthritis or degenerative joint disease undergoing TKA. It is designed as a prospective, randomized trial where patients are blinded to their treatment arm. Patients will be randomized to conventional vs. robotically-assisted techniques in the operating room and, other than the surgical technique, will receive the same perioperative care and identical implants. The investigators aim to measure utility of robotic-assisted TKA through a range of early and short-term clinical, functional, and radiographic outcome measures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Conventional vs. Robotic-Assisted Total Knee Arthroplasty: A Prospective, Randomized Trial of Clinical, Functional, and Radiographic Outcomes
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Non robotics-assisted Surgical System
Conventional, non-robotics-assisted total knee surgical system
Experimental: Navio™ Robotics-assisted Surgical System
Navio™ Robotics-assisted Surgical System
Device: Navio™ Robotics-assisted Surgical System
Intervention will evaluate the utility of robotic-assistance in patients undergoing total knee arthroplasty




Primary Outcome Measures :
  1. Score on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Up to 2 years ]
    The WOMAC is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  2. Score on the Timed Up and Go Test (TUG) [ Time Frame: Up to 2 years ]
    The TUG measures the time (in seconds) it takes a patient to rise from an armed chair, walk 3 meters, turn, and return to sitting in the same chair. The time taken to complete the task is strongly correlated to level of functional mobility, (i.e., the more time taken, the more dependent in activities of daily living). Risk for Falls: high risk (>13.5 seconds), none/low/moderate (<13.5 seconds).


Secondary Outcome Measures :
  1. Score on Short-Form 12 Health Questionnaire (SF-12) [ Time Frame: Up to 2 years ]
    The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

  2. Score on New Knee Society Scores (2011 KSS) [ Time Frame: Up to 2 years ]
    The 2011 KSS is a physician- and patient-derived scoring system that has been validated and demonstrated to be a responsive method for assessing objective and subjective outcomes after TKA. This scale comprises four separate subscales: (a) objective knee score (seven items: 100 points); (b) patient satisfaction score (five items: 40 points); (c) patient expectations score (three items: 15 points); and (d) functional activity score (19 items: 100 points). Score 80-100: Excellent; Score 70-79: Good; Score 60-69: Fair; Score below 60: Poor

  3. Score on Global Rating Score of Knee Function (GRS) [ Time Frame: Up to 2 years ]
    Participants will be asked to rate their perception of knee functional ability on a scale of 0 to 100%. A score of 0 represents a complete disability and a score of 100 represents a level of knee function prior to the patient having any symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age between 40 and 85
  • body mass index (BMI) less than 40.0 kg/m^2
  • end-stage knee osteoarthritis (Kellgren and Lawrence grade 4)
  • failure of a minimum 12 weeks of nonoperative management
  • English fluency

Exclusion Criteria:

  • history of inflammatory arthropathy in the same knee
  • history of prior open knee surgery in the same knee
  • history of prior osteotomy or periarticular fracture
  • deformity > 15 degrees from a neutral mechanical axis
  • gross ligamentous incompetence of the medial or lateral collateral ligaments
  • musculoskeletal involvement beyond unilateral knee osteoarthritis significantly limiting their function
  • unwillingness or inability to participate in the proposed study protocol and follow-up

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): NCT03519269


Contacts
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Contact: Jacqueline Lenahan, BS 212-305-8193 jl5092@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Herbert John Cooper, MD    212-305-6959    hjc2008@cumc.columbia.edu   
Principal Investigator: Herbert John Cooper, MD         
Sponsors and Collaborators
Columbia University
Smith & Nephew, Inc.
Investigators
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Principal Investigator: Herbert John Cooper, MD Columbia University

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Responsible Party: Herbert John Cooper, MD, Assistant Professor of Orthopaedic Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT03519269    
Other Study ID Numbers: AAAR6537
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Herbert John Cooper, MD, Columbia University:
total knee replacement
robotic surgery
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases