NCT03317834|CompletedResultsFDA Device
Navio With Total Knee Arthroplasty
Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty
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Sponsor study identifier
observational
122
1 country
6
Study Start
November 13, 2017
Actual (reported)Primary Completion
October 25, 2018
Actual (reported)Study Completion
May 27, 2021
Actual (reported)The purpose of this study is to demonstrate superior accuracy with the Navio ™ Robotic-assisted Surgical System in achieving desired post-operative mechanical alignment, compared to TKA procedures using standard instruments. An additional study purpose is to document clinical and patient-reported outcomes in subjects receiving TKA with the Navio ™ system.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 27, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 18, 2017
Actual (reported)October 23, 2017
Actual (reported)November 13, 2017
Actual (reported)October 25, 2018
Actual (reported)May 27, 2021
Actual (reported)October 8, 2024
Actual (reported)Count of Participants With Post-operative Mechanical Alignment
The number of participants achieving post-operative mechanical alignment within ±3 degrees from target with "Yes" indicating mechanical alignment was achieved and "No" indicating mechanical alignment was not achieved.
1 month
Count of Participants With Implant Survival
2 years
Knee Society Score 2011
Baseline, 1 month, 6 months, 1 year, and 2 years
Quality of Life EQ-5D-5L
Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Forgotten Joint Score (FJS)
Baseline, 1 month, 6 months, 1 year, 2 years
Hospital Length of Stay
During hospitalization, up to 6 days
Total Knee Replacement with Navio Surgical Systems
Total Knee Replacement
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
To eliminate the potential for selection bias, Investigators should screen all subjects undergoing a Navio™ assisted TKA. In order to do so, only the existing information obtained per standard routine medical procedures will be used. No study-specific screening procedures, activities or questionnaires will be performed during pre-screening.
Hedley Orthopedics
Phoenix, Arizona, 85016, United States
Orthopaedic Associates of Central Arizona
Scottsdale, Arizona, 86305, United States
San Diego Orthopaedic
San Diego, California, 92103, United States
Bronson Health
Kalamazoo, Michigan, 49006, United States
Hospital for Joint Disease Orthopaedic Institute
New York, New York, 10003, United States
OrthoNeuro
Albany, Ohio, 43054, United States
Julie Lankiewicz
Smith & Nephew, Inc.
122 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2017
First Posted
October 23, 2017
Study Start
November 13, 2017
Actual (reported)The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)
Contact the study team to confirm eligibility.
Primary Completion
October 25, 2018
Actual (reported)Study Completion
May 27, 2021
Actual (reported)Last Updated
October 8, 2024
Results First Posted
October 8, 2024
Record last verified: 2023-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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