Clinical trial NCT03317834: Navio With Total Knee Arthroplasty
Official title: Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Arthroplasty of Knee
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-23
Enrollment: 122
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subject was considered skeletally mature at the time of cone implantation (at least 18 years or older.)
3. 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.
4. Subject plans to be available through two (2) years postoperative follow-up.

Exclusion Criteria:

1. Subject has BMI ≥ 40.
2. 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).
3. Subject is deemed by investigator to require a constrained or deep dish tibial insert.
4. Subject has inadequate bone stock to support the device (severe osteopenia, history of severe osteoporosis or severe osteopenia).
5. Subject has mental or neurologic condition(s) that may pre-empt the ability or willingness to restrict activities.
6. Subject is 80 years of age or older.
7. Subject is a prisoner or impending incarceration.

Primary outcomes:
measure: Count of Participants With Post-operative Mechanical Alignment
timeFrame: 1 month
Secondary outcomes:
measure: Count of Participants With Implant Survival
timeFrame: 2 years
measure: Knee Society Score 2011
timeFrame: Baseline, 1 month, 6 months, 1 year, and 2 years
measure: Quality of Life EQ-5D-5L
timeFrame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
measure: Forgotten Joint Score (FJS)
timeFrame: Baseline, 1 month, 6 months, 1 year, 2 years
measure: Hospital Length of Stay
timeFrame: During hospitalization, up to 6 days
measure: Operative Time
timeFrame: During surgery, up to 235 minutes
measure: Radiographic Assessment - Anteroposterior (AP) Angle
timeFrame: Baseline, 1 month, 6 months, 1 year, and 2 years
measure: Radiographic Assessment - Lateral Angle
timeFrame: Baseline, 1 month, 6 months, 1 year, and 2 years
measure: Radiographic Assessment - Count of Participant Displacements
timeFrame: 6 months
measure: Radiographic Assessment - Displacement Measurement
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hedley Orthopedics
state: Arizona
city: Scottsdale
country: United States
facility: Orthopaedic Associates of Central Arizona
state: Arizona
city: San Diego
country: United States
facility: San Diego Orthopaedic
state: California
city: Kalamazoo
country: United States
facility: Bronson Health
state: Michigan
city: New York
country: United States
facility: Hospital for Joint Disease Orthopaedic Institute
state: New York
city: Albany
country: United States
facility: OrthoNeuro
state: Ohio
Study officials:
affiliation: Smith & Nephew, Inc.
name: Julie Lankiewicz
role: STUDY_CHAIR
References: