Navio With Total Knee Arthroplasty
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ClinicalTrials.gov Identifier: NCT03317834 |
Recruitment Status :
Active, not recruiting
First Posted : October 23, 2017
Last Update Posted : September 18, 2019
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Condition or disease | Intervention/treatment |
---|---|
Total Knee Arthroplasty Arthroplasty of Knee | Device: Navio ™ Robotic-assisted Surgical System |
Total Knee Arthroplasty (TKA) has become an effective and reliable treatment for arthritis of the knee (1). TKA is associated with low morbidity and mortality, and its effectiveness in reducing joint pain and improving range of motion is well established. In 2014, over 750,000 knee replacements were performed in the US (2).
A significant innovation in TKA has been the introduction of computer navigation and robotic-assisted surgery (3). One such technology is the Navio™ Robotic-assisted Surgical System. This system is a semi-autonomous image-free system. During the surgery, the surgeon maps the condylar landmarks and determines alignment indices to define the volume and orientation of bone to be removed. The tools to remove the bone and place the implants are controlled and manipulated by the surgeon with the guidance of a 3-dimensional digital map of the surgical surface.
Originally the Navio™ system was launched for use in unicondylar knee replacement only. To date, there have been over 1000 unicondylar knee replacement surgeries using the system. In 2017, Smith & Nephew Inc. expanded the indications for the Navio™ system to include TKA. The purpose of this multicenter, prospective study is to evaluate outcomes associated with this new indication.
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty |
Actual Study Start Date : | October 30, 2017 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | October 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Study Population
Total Knee Replacement with Navio Surgical Systems
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Device: Navio ™ Robotic-assisted Surgical System
Total Knee Replacement |
- Post-operative Mechanical Alignment [ Time Frame: 1 month ]the proportion of subjects achieving post-operative mechanical alignment
- Implant survival rate [ Time Frame: 2 years ]Did knee survive with no revision through 2 years
- Knee Society Score 2011 [ Time Frame: 2 years ]Patient Reported Outcomes using Knee Society Score 2011 questionnaire
- Quality of Life (EQ-5D) 5L [ Time Frame: 2 years ]Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire
- Forgotten Joint Score (FJS) [ Time Frame: 2 years ]Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire
- Radiographic Assessments [ Time Frame: at PreOp, 1month, 6 month, 1 year and 2 year visits ]Mechanical Alignment on Long Leg X-rays,Standard AP, Lateral, and Patellar (Skyline or Merchant) X-rays

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Ages Eligible for Study: | up to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subject requires primary total knee arthroplasty with the Journey II BCS or Cruciate-Retraining (CR) Systems due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis.
- Subject was considered skeletally mature at the time of cone implantation (at least 18 years or older.)
- Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form.
- Subject plans to be available through two (2) years postoperative follow-up.
Exclusion Criteria:
- Subject has BMI ≥ 40.
- Subject has condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
- Subject is deemed by investigator to require a constrained or deep dish tibial insert.
- Subject has inadequate bone stock to support the device (severe osteopenia, history of severe osteoporosis or severe osteopenia).
- Subject has mental or neurologic condition(s) that may pre-empt the ability or willingness to restrict activities.
- Subject is 80 years of age or older.
- Subject is a prisoner or impending incarceration.

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): NCT03317834
United States, Arizona | |
Hedley Orthopedics | |
Phoenix, Arizona, United States, 85016 | |
Orthopaedic Associates of Central Arizona | |
Scottsdale, Arizona, United States, 86305 | |
United States, California | |
San Diego Orthopaedic | |
San Diego, California, United States, 92103 | |
United States, Michigan | |
Bronson Health | |
Kalamazoo, Michigan, United States, 49006 | |
United States, New York | |
Hospital for Joint Disease Orthopaedic Institute | |
New York, New York, United States, 10003 | |
United States, Ohio | |
OrthoNeuro | |
Albany, Ohio, United States, 43054 |
Study Chair: | Kelli Armstrong | Smith & Nephew, Inc. |
Responsible Party: | Smith & Nephew, Inc. |
ClinicalTrials.gov Identifier: | NCT03317834 |
Other Study ID Numbers: |
17-NPFS-04 |
First Posted: | October 23, 2017 Key Record Dates |
Last Update Posted: | September 18, 2019 |
Last Verified: | September 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |