Primary Osteoarthritis of Knee NosNCT03523897
A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes
A study testing Robot Assisted Total Knee Replacement and Traditional Total Knee Replacement in people with Primary Osteoarthritis of Knee Nos, run by Virtua Health, Inc. at 1 site in United States.
Trial summary
This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Osteoarthritis of Knee Nos
- What is being tested?
- Robot Assisted Total Knee Replacement and Traditional Total Knee Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2018to 14 Jul 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
- Willing to provide informed consent, participate in study, and comply with study protocol
Who cannot join
- Pregnant or contemplating pregnancy prior to surgery;
- Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement)
- Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups)
- Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans
Trial locations and contacts
1 site in 1 country.
United States1 site
Virtua Joint Replacement Institute
Voorhees Township, New Jersey, 08043
About this study
Official title: A Prospective Study to Examine Patient Satisfaction, Function, and Limb Alignment Outcomes for Mako Versus Non-Mako Total Knee Replacements
This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include:
- Patients' self-reported awareness of their artificial joints during activities of daily living;
- Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;
- Patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health;
- The accuracy of implant placement and limb alignment
- Conditions
- Primary Osteoarthritis of Knee Nos
- Being tested
- Robot Assisted Total Knee Replacement, Traditional Total Knee Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Assisted Total Knee ReplacementProcedure or surgery
A robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
Traditional Total Knee ReplacementProcedure or surgery
A surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
| Study group | Role | What they receive |
|---|---|---|
| Robot Assisted Total Knee Replacement | Active comparator | In addition to expert judgment and hand-eye coordination, the surgeon also relies on a robot in making cuts within the pre-determined diseased areas of the joints and placing the implants. This is made possible by uploading 3-dimensional (3D) images of the knee joints into the robot prior to surgery. The robot uses these 3D images to guide the surgeon during the procedure. The 3D images are obtained from a computerized tomography (CT) scan that combines a series of X-ray images taken from different angles to create cross-sectional images of the bones. Receives: Procedure: Robot Assisted Total Knee Replacement |
| Traditional Total Knee Replacement | Active comparator | The traditional method where the surgeon employs mechanical guides, expert judgment, and natural hand-eye coordination in making the necessary cuts to prepare the bone for the implant as well as in placing the implant. Receives: Procedure: Traditional Total Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Forgotten Joint Score (FJS)
The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)
Measured: 1 year
Secondary outcomes (3)
Patient Reported Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a knee-specific instrument used to evaluate short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 42 questions in 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Measured: 1 year
Patient Reported Veterans Rand 12-item Health Survey Score (VR-12)
The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health.
Measured: 1 year
The Mechanical Alignment of the Post-operative Limb
The mechanical alignment of the entire post-operative limb will be measured at 6 weeks by long-limb radiograph cassettes and compared to the pre-operative plan for accuracy and deviation less than or greater than 3 degrees from the intended target. From each treatment group, the percentage of patients with radiographic outliers (deviation greater that 3 degrees from the expected implant placement) will be compared.
Measured: 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start20 Apr 2018
- Primary completion14 Jul 2022
- Study completion14 Jul 2022
Why it stopped: Insufficient research coordinating support to continue recruitment and data collection
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 Primary Osteoarthritis of Knee NosStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virtua Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Reid, MD, Principal investigator, Virtua Joint Replacement Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523897
- Sponsor's protocol ID
- VirtuaHealth-Mako
- Status last verified
- May 2025
- First submitted
- 13 Mar 2018
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to pblish study outcomes in a relevant orthopedic journal
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Examine Patient Satisfaction, Function, and Limb Alignment Outcomes for Mako Versus Non-Mako Total Knee Replacements
- ClinicalTrials.gov ID
- NCT03523897
- Acronym / sponsor ID
- VirtuaHealth-Mako
- Conditions
- Primary Osteoarthritis of Knee Nos
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient research coordinating support to continue recruitment and data collection
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Virtua Health, Inc.University, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to see if outcomes for patients that receive the traditional total knee replacement surgical technique are different than the outcomes for patients that receive robot-assisted total knee replacement. The outcomes we will be tracking include:
- Patients' self-reported awareness of their artificial joints during activities of daily living;
- Patient's self-reported pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life;
- Patients' self-reported general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health;
- The accuracy of implant placement and limb alignment
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot Assisted Total Knee Replacement | Active comparator | Procedure: Robot Assisted Total Knee ReplacementIn addition to expert judgment and hand-eye coordination, the surgeon also relies on a robot in making cuts within the pre-determined diseased areas of the joints and placing the implants. This is made possible by uploading 3-dimensional (3D) images of the knee joints into the robot prior to surgery. The robot uses these 3D images to guide the surgeon during the procedure. The 3D images are obtained from a computerized tomography (CT) scan that combines a series of X-ray images taken from different angles to create cross-sectional images of the bones. |
| Traditional Total Knee Replacement | Active comparator | Procedure: Traditional Total Knee ReplacementThe traditional method where the surgeon employs mechanical guides, expert judgment, and natural hand-eye coordination in making the necessary cuts to prepare the bone for the implant as well as in placing the implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI
- Willing to provide informed consent, participate in study, and comply with study protocol
Key exclusion criteria (4 listed)
- Pregnant or contemplating pregnancy prior to surgery;
- Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement)
- Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups)
- Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans
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 |
|---|---|---|
| Robot Assisted Total Knee ReplacementA robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints | Procedure or surgery | Robot Assisted Total Knee Replacement |
| Traditional Total Knee ReplacementA surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints | Procedure or surgery | Traditional Total Knee Replacement |
Primary outcome
Patient Reported Forgotten Joint Score (FJS)
Time frame: 1 year
The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)
3 secondary outcomes
Patient Reported Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1 year
Patient Reported Veterans Rand 12-item Health Survey Score (VR-12)
Time frame: 1 year
The Mechanical Alignment of the Post-operative Limb
Time frame: 6 weeks postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Plan to pblish study outcomes in a relevant orthopedic journal
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.
Jeremy Reid, MD principal investigator
Virtua Joint Replacement Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Assisted Total Knee Replacement and Traditional Total Knee Replacement in people with Primary Osteoarthritis of Knee Nos, run by Virtua Health, Inc. 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2025). 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?
Patient Reported Forgotten Joint Score (FJS) (time frame: 1 year). 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 6 Jun 2025.