Arthroplasty of Knee, Total Knee Arthroplasty
Conditions
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.
Interventions
DEVICENavio ™ Robotic-assisted Surgical System
Total Knee Replacement
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| Operative Time | During surgery, up to 235 minutes | Operative time taken for the surgery measured in minutes. |
Countries
United States
Participant flow
Recruitment details
The enrollment for this study was conducted between 13 November 2017 and 27 May 2021 across six investigative sites.
Participants by arm
| Arm | Count |
|---|---|
| Study Population Total Knee Replacement with Navio Surgical Systems
Navio ™ Robotic-assisted Surgical System: Total Knee Replacement | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Device Revision | 5 |
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Study Population |
|---|---|
| Age, Continuous | 69.51 years STANDARD_DEVIATION 8.683 |
| Age, Customized Age Category < 60 years | 13 Participants |
| Age, Customized Age Category >=60 years | 109 Participants |
| Body Mass Index (BMI) | 31.32 kg/m^2 STANDARD_DEVIATION 5.102 |
| Race/Ethnicity, Customized Race Black | 7 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants |
| Race/Ethnicity, Customized Race White | 107 Participants |
| Region of Enrollment United States | 122 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 122 |
| other Total, other adverse events | 12 / 122 |
| serious Total, serious adverse events | 26 / 122 |
Outcome results
Primary
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.
Time frame: 1 month
Population: Number of Participants Analyzed indicates the data available for the time frame specified.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Population | Count of Participants With Post-operative Mechanical Alignment | Yes | 106 Participants |
| Study Population | Count of Participants With Post-operative Mechanical Alignment | No | 9 Participants |
Secondary
Count of Participants With Implant Survival
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.
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Population | Count of Participants With Implant Survival | No | 117 Participants |
| Study Population | Count of Participants With Implant Survival | Yes | 5 Participants |
Secondary
Forgotten Joint Score (FJS)
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.
Time frame: Baseline, 1 month, 6 months, 1 year, 2 years
Population: Number of Participants Analyzed indicates the data available for the time frame specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Population | Forgotten Joint Score (FJS) | Baseline | 11.84 score on a scale | Standard Deviation 12.084 |
| Study Population | Forgotten Joint Score (FJS) | 1 Month | 17.31 score on a scale | Standard Deviation 19.603 |
| Study Population | Forgotten Joint Score (FJS) | 6 Months | 51.45 score on a scale | Standard Deviation 25.377 |
| Study Population | Forgotten Joint Score (FJS) | 1 Year | 66.31 score on a scale | Standard Deviation 26.598 |
| Study Population | Forgotten Joint Score (FJS) | 2 Years | 78.56 score on a scale | Standard Deviation 26.095 |
Secondary
Hospital Length of Stay
Hospital length of stay measured in days
Time frame: During hospitalization, up to 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Hospital Length of Stay | 2.04 days | Standard Deviation 0.837 |
Secondary
Knee Society Score 2011
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)
Time frame: Baseline, 1 month, 6 months, 1 year, and 2 years
Population: Number of Participants Analyzed indicates the data available for the time frame specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Population | Knee Society Score 2011 | Patient Expectation: Baseline | 14.21 score on a scale | Standard Deviation 1.627 |
| Study Population | Knee Society Score 2011 | Patient Expectation: 1 Month | 8.42 score on a scale | Standard Deviation 2.819 |
| Study Population | Knee Society Score 2011 | Patient Expectation: 6 Months | 9.78 score on a scale | Standard Deviation 3.391 |
| Study Population | Knee Society Score 2011 | Patient Expectation: 1 Year | 9.39 score on a scale | Standard Deviation 3.04 |
| Study Population | Knee Society Score 2011 | Patient Expectation: 2 Years | 9.97 score on a scale | Standard Deviation 2.485 |
| Study Population | Knee Society Score 2011 | Functional Activity: Baseline | 42.13 score on a scale | Standard Deviation 15.914 |
| Study Population | Knee Society Score 2011 | Functional Activity: 1 Month | 46.55 score on a scale | Standard Deviation 16.155 |
| Study Population | Knee Society Score 2011 | Functional Activity: 6 Months | 72.28 score on a scale | Standard Deviation 15.819 |
| Study Population | Knee Society Score 2011 | Functional Activity: 1 Year | 79.35 score on a scale | Standard Deviation 15.775 |
| Study Population | Knee Society Score 2011 | Functional Activity: 2 Years | 83.42 score on a scale | Standard Deviation 14.931 |
| Study Population | Knee Society Score 2011 | Objective: Baseline | 49.40 score on a scale | Standard Deviation 21.382 |
| Study Population | Knee Society Score 2011 | Objective: 1 Month | 63.02 score on a scale | Standard Deviation 17.25 |
| Study Population | Knee Society Score 2011 | Objective: 6 Months | 78.98 score on a scale | Standard Deviation 15.867 |
| Study Population | Knee Society Score 2011 | Objective: 1 Year | 82.10 score on a scale | Standard Deviation 14.339 |
| Study Population | Knee Society Score 2011 | Objective: 2 Years | 84.51 score on a scale | Standard Deviation 13.463 |
| Study Population | Knee Society Score 2011 | Patient Satisfaction: Baseline | 10.93 score on a scale | Standard Deviation 6.31 |
| Study Population | Knee Society Score 2011 | Patient Satisfaction: 1 Month | 22.64 score on a scale | Standard Deviation 7.028 |
| Study Population | Knee Society Score 2011 | Patient Satisfaction: 6 Months | 29.42 score on a scale | Standard Deviation 8.358 |
| Study Population | Knee Society Score 2011 | Patient Satisfaction: 1 Year | 32.19 score on a scale | Standard Deviation 7.11 |
| Study Population | Knee Society Score 2011 | Patient Satisfaction: 2 Years | 33.42 score on a scale | Standard Deviation 5.941 |
Secondary
Operative Time
Operative time taken for the surgery measured in minutes.
Time frame: During surgery, up to 235 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Operative Time | 90.48 minutes | Standard Deviation 29.316 |
Secondary
Quality of Life EQ-5D-5L
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.
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Population: Number of Participants Analyzed indicates the data available for the time frame specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Population | Quality of Life EQ-5D-5L | Baseline | 73.44 score on a scale | Standard Deviation 16.643 |
| Study Population | Quality of Life EQ-5D-5L | 1 Month | 75.01 score on a scale | Standard Deviation 12.251 |
| Study Population | Quality of Life EQ-5D-5L | 6 Months | 78.44 score on a scale | Standard Deviation 13.462 |
| Study Population | Quality of Life EQ-5D-5L | 1 Year | 81.82 score on a scale | Standard Deviation 10.012 |
| Study Population | Quality of Life EQ-5D-5L | 2 Years | 84.18 score on a scale | Standard Deviation 9.364 |
Secondary
Radiographic Assessment - Anteroposterior (AP) Angle
AP Angle mechanical alignment of femoral flexion, tibial angle, and total valgus angle
Time frame: Baseline, 1 month, 6 months, 1 year, and 2 years
Population: Number of Participants Analyzed indicates the data available for the time frame specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Femoral Flexion: Baseline | 65.39 degrees | Standard Deviation 40.711 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Femoral Flexion: 1 Month | 71.77 degrees | Standard Deviation 37.265 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Femoral Flexion: 6 Months | 70.10 degrees | Standard Deviation 38.357 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Femoral Flexion: 1 Year | 73.41 degrees | Standard Deviation 35.754 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Femoral Flexion: 2 Years | 72.89 degrees | Standard Deviation 36.198 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Tibial Angle: Baseline | 62.34 degrees | Standard Deviation 38.578 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Tibial Angle: 1 Month | 69.07 degrees | Standard Deviation 37.639 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Tibial Angle: 6 Months | 66.59 degrees | Standard Deviation 38.915 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Tibial Angle: 1 Year | 70.51 degrees | Standard Deviation 36.435 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Tibial Angle: 2 Years | 70.16 degrees | Standard Deviation 36.76 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Total Valgus Angle: Baseline | 126.46 degrees | Standard Deviation 79.078 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Total Valgus Angle: 1 Month | 140.15 degrees | Standard Deviation 74.31 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Total Valgus Angle: 6 Months | 136.63 degrees | Standard Deviation 77.309 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Total Valgus Angle: 1 Year | 143.89 degrees | Standard Deviation 71.527 |
| Study Population | Radiographic Assessment - Anteroposterior (AP) Angle | Total Valgus Angle: 2 Years | 143.05 degrees | Standard Deviation 72.249 |
Secondary
Radiographic Assessment - Count of Participant Displacements
Number of participants with either no displacement or displacement observed at the 6-month follow-up visit.
Time frame: 6 months
Population: Number of Participants Analyzed indicates the data available for the time frame specified.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Population | Radiographic Assessment - Count of Participant Displacements | No Displacement | 62 Participants |
| Study Population | Radiographic Assessment - Count of Participant Displacements | Displacement | 24 Participants |
Secondary
Radiographic Assessment - Displacement Measurement
Degree of displacement measured in millimeters (mm) for participants with displacement observed at the 6-month follow-up visit.
Time frame: 6 months
Population: Number of Participants that showed displacement with data available for the time frame specified.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Radiographic Assessment - Displacement Measurement | 3.95 millimeters | Standard Deviation 2.663 |
Secondary
Radiographic Assessment - Lateral Angle
Lateral Angle mechanical alignment of femoral flexion and tibial angle.
Time frame: Baseline, 1 month, 6 months, 1 year, and 2 years
Population: Number of Participants Analyzed indicates the data available for the time frame specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Population | Radiographic Assessment - Lateral Angle | Lateral Angle Femoral Flexion: Baseline | 6.12 degrees | Standard Deviation 2.233 |
| Study Population | Radiographic Assessment - Lateral Angle | Lateral Angle Femoral Flexion: 1 Month | 2.68 degrees | Standard Deviation 2.6 |
| Study Population | Radiographic Assessment - Lateral Angle | Lateral Angle Femoral Flexion: 6 Months | 2.41 degrees | Standard Deviation 2.499 |
| Study Population | Radiographic Assessment - Lateral Angle | Lateral Angle Femoral Flexion: 1 Year | 3.10 degrees | Standard Deviation 9.465 |
| Study Population | Radiographic Assessment - Lateral Angle | Lateral Angle Femoral Flexion: 2 Years | 3.31 degrees | Standard Deviation 9.763 |
| Study Population | Radiographic Assessment - Lateral Angle | Tibial Angle: Baseline | 80.18 degrees | Standard Deviation 19.654 |
| Study Population | Radiographic Assessment - Lateral Angle | Tibial Angle: 1 Month | 66.30 degrees | Standard Deviation 37.277 |
| Study Population | Radiographic Assessment - Lateral Angle | Tibial Angle: 6 Months | 63.79 degrees | Standard Deviation 38.965 |
| Study Population | Radiographic Assessment - Lateral Angle | Tibial Angle: 1 Year | 66.56 degrees | Standard Deviation 38.965 |
| Study Population | Radiographic Assessment - Lateral Angle | Tibial Angle: 2 Years | 66.84 degrees | Standard Deviation 37.326 |