Navio Robotic Versus Conventional Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03519269|
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: Navio™ Robotics-assisted Surgical System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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).
- 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.
- 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
- 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.
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
|Contact: Jacqueline Lenahan, BSfirstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Herbert John Cooper, MD 212-305-6959 email@example.com|
|Principal Investigator: Herbert John Cooper, MD|
|Principal Investigator:||Herbert John Cooper, MD||Columbia University|