Osteoarthritis, KneeNCT03519269
Navio Robotic Versus Conventional Total Knee Arthroplasty
A study testing Navio™ Robotics-assisted Surgical System in people with Osteoarthritis, Knee, run by Columbia University at 1 site in United States.
Trial summary
Total knee replacement surgery is a conventional approach to alleviating the pain and lack of function resulting from arthritis of the knee. While conventional knee replacement surgery is highly successful, incidences of improperly installed replacement parts are not uncommon. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Navio™ Robotics-assisted Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 40 and 85
- body mass index (BMI) less than 40.0 kg/m^2
- end-stage knee osteoarthritis (Kellgren and Lawrence grade 4)
- failure of a minimum 12 weeks of nonoperative management
- English fluency
Who cannot join
- history of inflammatory arthropathy in the same knee
- history of prior open knee surgery in the same knee
- history of prior osteotomy or periarticular fracture
- deformity > 15 degrees from a neutral mechanical axis
- gross ligamentous incompetence of the medial or lateral collateral ligaments
- musculoskeletal involvement beyond unilateral knee osteoarthritis significantly limiting their function
- unwillingness or inability to participate in the proposed study protocol and follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Conventional vs. Robotic-Assisted Total Knee Arthroplasty: A Prospective, Randomized Trial of Clinical, Functional, and Radiographic Outcomes
Total knee replacement surgery is a conventional approach to alleviating the pain and lack of function resulting from arthritis of the knee. While conventional knee replacement surgery is highly successful, incidences of improperly installed replacement parts are not uncommon. To improve outcomes, robotic-assisted total knee replacement surgery has recently become available, and has been shown to be extremely effective for partial knee replacement surgery. However, further research is needed to determine if this same technology can be equally effective for total knee replacement surgery. The present study will evaluate outcomes of robotic-assisted versus conventional total knee replacement surgery in patients between 40 and 85 years old with end stage arthritis of the knee. Other than surgical technique, patients will receive the same operative care and knee replacement implants. In addition to standard x-rays, subjects will be asked to complete several short-term clinical and functional tests and questionnaires to determine outcomes of their surgery.
Read the detailed description
Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific. Despite continued improvement in manual instrumentation, postoperative malalignment is still reported in a significant number of patients when these manual instruments are used. Robotic-assisted TKA was developed specifically to improve surgical accuracy, and has been shown to significantly improve accuracy of alignment and joint-line restoration. However, these improvements came at the cost of higher complication rates and were not shown to translate into meaningful clinical outcomes with these first-generation systems. Newer-generation robotic technology offers several advantages over earlier versions including the potential to dynamically assess soft tissues over a range of motion and the ability to use haptic control in bone preparation. Modern robotic-assisted knee surgery has also demonstrated superior outcomes over conventional instrumentation in unicompartmental knee arthroplasty (UKA). This newer-generation of robotic technology, which has quickly become the standard-of-care for many knee surgeons who perform UKA, has recently been approved by the United States Food and Drug Administration (FDA) for use in TKA. Prior to consideration of widespread adoption of this newer technology in patients undergoing TKA, well-designed clinical trials are necessary to study its efficacy in this population. The proposed study evaluates the efficacy of robotic-assistance in patients between 40 and 85 years old with end-stage knee osteoarthritis or degenerative joint disease undergoing TKA. It is designed as a prospective, randomized trial where patients are blinded to their treatment arm. Patients will be randomized to conventional vs. robotically-assisted techniques in the operating room and, other than the surgical technique, will receive the same perioperative care and identical implants. The investigators aim to measure utility of robotic-assisted TKA through a range of early and short-term clinical, functional, and radiographic outcome measures.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Navio™ Robotics-assisted Surgical System
- Keywords
- total knee replacement, robotic surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navio™ Robotics-assisted Surgical SystemDevice
Intervention will evaluate the utility of robotic-assistance in patients undergoing total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Non robotics-assisted Surgical System | No intervention | Conventional, non-robotics-assisted total knee surgical system |
| Navio™ Robotics-assisted Surgical System | Experimental | Navio™ Robotics-assisted Surgical System Receives: Device: Navio™ Robotics-assisted Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Up to 2 years
Score on the Timed Up and Go Test (TUG)
The TUG measures the time (in seconds) it takes a patient to rise from an armed chair, walk 3 meters, turn, and return to sitting in the same chair. The time taken to complete the task is strongly correlated to level of functional mobility, (i.e., the more time taken, the more dependent in activities of daily living). Risk for Falls: high risk (>13.5 seconds), none/low/moderate (<13.5 seconds).
Measured: Up to 2 years
Secondary outcomes (3)
Score on Short-Form 12 Health Questionnaire (SF-12)
The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: Up to 2 years
Score on New Knee Society Scores (2011 KSS)
The 2011 KSS is a physician- and patient-derived scoring system that has been validated and demonstrated to be a responsive method for assessing objective and subjective outcomes after TKA. This scale comprises four separate subscales: (a) objective knee score (seven items: 100 points); (b) patient satisfaction score (five items: 40 points); (c) patient expectations score (three items: 15 points); and (d) functional activity score (19 items: 100 points). Score 80-100: Excellent; Score 70-79: Good; Score 60-69: Fair; Score below 60: Poor
Measured: Up to 2 years
Score on Global Rating Score of Knee Function (GRS)
Participants will be asked to rate their perception of knee functional ability on a scale of 0 to 100%. A score of 0 represents a complete disability and a score of 100 represents a level of knee function prior to the patient having any symptoms.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start17 Apr 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Herbert John Cooper, MD, Columbia University
- Investigators
- Herbert John Cooper, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519269
- Sponsor's protocol ID
- AAAR6537
- Status last verified
- Sep 2026
- First submitted
- 26 Apr 2018
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional vs. Robotic-Assisted Total Knee Arthroplasty: A Prospective, Randomized Trial of Clinical, Functional, and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT03519269
- Acronym / sponsor ID
- AAAR6537
- Conditions
- Osteoarthritis, Knee
- Keywords
- total knee replacement, robotic surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee replacement surgery is a conventional approach to alleviating the pain and lack of function resulting from arthritis of the knee. While conventional knee replacement surgery is highly successful, incidences of improperly installed replacement parts are not uncommon. To improve outcomes, robotic-assisted total knee replacement surgery has recently become available, and has been shown to be extremely effective for partial knee replacement surgery. However, further research is needed to determine if this same technology can be equally effective for total knee replacement surgery. The present study will evaluate outcomes of robotic-assisted versus conventional total knee replacement surgery in patients between 40 and 85 years old with end stage arthritis of the knee. Other than surgical technique, patients will receive the same operative care and knee replacement implants. In addition to standard x-rays, subjects will be asked to complete several short-term clinical and functional tests and questionnaires to determine outcomes of their surgery.
Detailed description
Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific. Despite continued improvement in manual instrumentation, postoperative malalignment is still reported in a significant number of patients when these manual instruments are used. Robotic-assisted TKA was developed specifically to improve surgical accuracy, and has been shown to significantly improve accuracy of alignment and joint-line restoration. However, these improvements came at the cost of higher complication rates and were not shown to translate into meaningful clinical outcomes with these first-generation systems. Newer-generation robotic technology offers several advantages over earlier versions including the potential to dynamically assess soft tissues over a range of motion and the ability to use haptic control in bone preparation. Modern robotic-assisted knee surgery has also demonstrated superior outcomes over conventional instrumentation in unicompartmental knee arthroplasty (UKA). This newer-generation of robotic technology, which has quickly become the standard-of-care for many knee surgeons who perform UKA, has recently been approved by the United States Food and Drug Administration (FDA) for use in TKA. Prior to consideration of widespread adoption of this newer technology in patients undergoing TKA, well-designed clinical trials are necessary to study its efficacy in this population. The proposed study evaluates the efficacy of robotic-assistance in patients between 40 and 85 years old with end-stage knee osteoarthritis or degenerative joint disease undergoing TKA. It is designed as a prospective, randomized trial where patients are blinded to their treatment arm. Patients will be randomized to conventional vs. robotically-assisted techniques in the operating room and, other than the surgical technique, will receive the same perioperative care and identical implants. The investigators aim to measure utility of robotic-assisted TKA through a range of early and short-term clinical, functional, and radiographic outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non robotics-assisted Surgical System | No intervention | –Conventional, non-robotics-assisted total knee surgical system |
| Navio™ Robotics-assisted Surgical System | Experimental | Device: Navio™ Robotics-assisted Surgical SystemNavio™ Robotics-assisted Surgical System |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 40 and 85
- body mass index (BMI) less than 40.0 kg/m^2
- end-stage knee osteoarthritis (Kellgren and Lawrence grade 4)
- failure of a minimum 12 weeks of nonoperative management
- English fluency
Key exclusion criteria (7 listed)
- history of inflammatory arthropathy in the same knee
- history of prior open knee surgery in the same knee
- history of prior osteotomy or periarticular fracture
- deformity > 15 degrees from a neutral mechanical axis
- gross ligamentous incompetence of the medial or lateral collateral ligaments
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™ Robotics-assisted Surgical SystemIntervention will evaluate the utility of robotic-assistance in patients undergoing total knee arthroplasty | Device | Navio™ Robotics-assisted Surgical System |
Primary outcome
Score on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Up to 2 years
The WOMAC is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Score on the Timed Up and Go Test (TUG)
Time frame: Up to 2 years
The TUG measures the time (in seconds) it takes a patient to rise from an armed chair, walk 3 meters, turn, and return to sitting in the same chair. The time taken to complete the task is strongly correlated to level of functional mobility, (i.e., the more time taken, the more dependent in activities of daily living). Risk for Falls: high risk (>13.5 seconds), none/low/moderate (<13.5 seconds).
3 secondary outcomes
Score on Short-Form 12 Health Questionnaire (SF-12)
Time frame: Up to 2 years
Score on New Knee Society Scores (2011 KSS)
Time frame: Up to 2 years
Score on Global Rating Score of Knee Function (GRS)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Herbert John Cooper, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navio™ Robotics-assisted Surgical System in people with Osteoarthritis, Knee, run by Columbia University at 1 site 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 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Score on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 15 Sep 2026.