Navio With Total Knee Arthroplasty

Completed

Conditions: Arthroplasty of Knee
Total Knee Arthroplasty

Interventions: Device: Navio ™ Robotic-assisted Surgical System

Registration Number: NCT03317834

Lead Sponsor: Smith & Nephew, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 122

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Population	Navio ™ Robotic-assisted Surgical System	Total Knee Replacement with Navio Surgical Systems

Primary Outcome Measures

Name	Time	Method
Count of Participants With Post-operative Mechanical Alignment	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Count of Participants With Implant Survival	2 years	Number of participants with implant survivorship where "No" indicates a revision surgery was not required and "Yes" indicates a revision surgery was required by the 2 year postoperative visit.
Knee Society Score 2011	Baseline, 1 month, 6 months, 1 year, and 2 years	The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in Total Knee Arthroplasty (TKA) participants. The 2011 Knee Society Score consists of 4 separate subscales with a higher number indicating a better outcome: * A Patient Expectation Score (5items: 15 points, range 0-15) * A Functional Activity Score (19 items: 100 points, range 0-100) * An "Objective" Knee Score (7 items: 100 points, range 0-100) * A Patient Satisfaction Score (5 items: 40 points, range 0-40)
Quality of Life EQ-5D-5L	Baseline, 1 Month, 6 Months, 1 Year, 2 Years	Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) was graded on a scale of 0 to 100, with 100 being the best health you can imagine and 0 indicating the worst.
Forgotten Joint Score (FJS)	Baseline, 1 month, 6 months, 1 year, 2 years	Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
Hospital Length of Stay	During hospitalization, up to 6 days	Hospital length of stay measured in days
Operative Time	During surgery, up to 235 minutes	Operative time taken for the surgery measured in minutes.
Radiographic Assessment - Anteroposterior (AP) Angle	Baseline, 1 month, 6 months, 1 year, and 2 years	AP Angle mechanical alignment of femoral flexion, tibial angle, and total valgus angle
Radiographic Assessment - Lateral Angle	Baseline, 1 month, 6 months, 1 year, and 2 years	Lateral Angle mechanical alignment of femoral flexion and tibial angle.
Radiographic Assessment - Count of Participant Displacements	6 months	Number of participants with either no displacement or displacement observed at the 6-month follow-up visit.
Radiographic Assessment - Displacement Measurement	6 months	Degree of displacement measured in millimeters (mm) for participants with displacement observed at the 6-month follow-up visit.

Trial Locations

Locations (6): OrthoNeuro
🇺🇸
Albany, Ohio, United States
Orthopaedic Associates of Central Arizona
🇺🇸
Scottsdale, Arizona, United States
Hospital for Joint Disease Orthopaedic Institute
🇺🇸
New York, New York, United States
Hedley Orthopedics
🇺🇸
Phoenix, Arizona, United States
San Diego Orthopaedic
🇺🇸
San Diego, California, United States
Bronson Health
🇺🇸
Kalamazoo, Michigan, United States