Total Knee ArthroplastyNCT03317834
Navio With Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty and Arthroplasty of Knee, run by Smith & Nephew, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Arthroplasty of Knee
- What is being tested?
- Navio ™ Robotic-assisted Surgical System
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Nov 2017to 27 May 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
OrthoNeuro
Albany, Ohio, 43054
Bronson Health
Kalamazoo, Michigan, 49006
Hospital for Joint Disease Orthopaedic Institute
New York, New York, 10003
Hedley Orthopedics
Phoenix, Arizona, 85016
San Diego Orthopaedic
San Diego, California, 92103
Orthopaedic Associates of Central Arizona
Scottsdale, Arizona, 86305
About this study
Official title: Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty
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.
Read the 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.
- Conditions
- Total Knee Arthroplasty, Arthroplasty of Knee
- Being tested
- Navio ™ Robotic-assisted Surgical System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navio ™ Robotic-assisted Surgical SystemDevice
Total Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Total Knee Replacement with Navio Surgical Systems Receives: Device: Navio ™ Robotic-assisted Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (10)
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.
Measured: 2 years
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)
Measured: Baseline, 1 month, 6 months, 1 year, and 2 years
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.
Measured: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
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.
Measured: Baseline, 1 month, 6 months, 1 year, 2 years
Hospital Length of Stay
Hospital length of stay measured in days
Measured: During hospitalization, up to 6 days
Operative Time
Operative time taken for the surgery measured in minutes.
Measured: During surgery, up to 235 minutes
Radiographic Assessment - Anteroposterior (AP) Angle
AP Angle mechanical alignment of femoral flexion, tibial angle, and total valgus angle
Measured: Baseline, 1 month, 6 months, 1 year, and 2 years
Radiographic Assessment - Lateral Angle
Lateral Angle mechanical alignment of femoral flexion and tibial angle.
Measured: Baseline, 1 month, 6 months, 1 year, and 2 years
Radiographic Assessment - Count of Participant Displacements
Number of participants with either no displacement or displacement observed at the 6-month follow-up visit.
Measured: 6 months
Radiographic Assessment - Displacement Measurement
Degree of displacement measured in millimeters (mm) for participants with displacement observed at the 6-month follow-up visit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start13 Nov 2017
- Primary completion25 Oct 2018
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Lankiewicz, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317834
- Sponsor's protocol ID
- 17-NPFS-04
- Status last verified
- Jun 2023
- First submitted
- 18 Oct 2017
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Patient-reported Outcomes Associated With the Use of the Navio™ Robotic-assisted Surgical System in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03317834
- Acronym / sponsor ID
- 17-NPFS-04
- Conditions
- Total Knee Arthroplasty, Arthroplasty of Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Device: Navio ™ Robotic-assisted Surgical SystemTotal Knee Replacement with Navio Surgical Systems |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navio ™ Robotic-assisted Surgical SystemTotal Knee Replacement | Device | Study Population |
Primary outcome
Count of Participants With Post-operative Mechanical Alignment
Time frame: 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.
10 secondary outcomes
Count of Participants With Implant Survival
Time frame: 2 years
Knee Society Score 2011
Time frame: Baseline, 1 month, 6 months, 1 year, and 2 years
Quality of Life EQ-5D-5L
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Forgotten Joint Score (FJS)
Time frame: Baseline, 1 month, 6 months, 1 year, 2 years
Hospital Length of Stay
Time frame: During hospitalization, up to 6 days
Operative Time
Time frame: During surgery, up to 235 minutes
Radiographic Assessment - Anteroposterior (AP) Angle
Time frame: Baseline, 1 month, 6 months, 1 year, and 2 years
Radiographic Assessment - Lateral Angle
Time frame: Baseline, 1 month, 6 months, 1 year, and 2 years
Radiographic Assessment - Count of Participant Displacements
Time frame: 6 months
Radiographic Assessment - Displacement Measurement
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Total Knee Arthroplasty
Recruiting
A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
Pain (Knee), Pain and Anxiety
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Recruiting
The Effect of Mind Mapping-Based Education on Postoperative Pain, Kinesiophobia, and Discharge Readiness in Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Lankiewicz study chair
Smith & Nephew, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty and Arthroplasty of Knee, run by Smith & Nephew, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participants With Post-operative Mechanical Alignment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.