OsteoarthritisARVISNCT06663384
ARVIS TKA vs Conventional TKA
A study testing Evaluation of Augmented Reality technology in TKA compared to standard TKA in people with Osteoarthritis, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
Trial summary
This study is a pilot analysis of a novel augmented reality guidance platform, the augmented reality visualization and information system (ARVIS, Insight Medical), with aims to demonstrate accuracy of bone resection and implant alignment during kinematic alignment total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Evaluation of Augmented Reality technology in TKA compared to standard TKA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Nov 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- Scheduled for primary conventional TKA with kinematic alignment
- Primary Diagnosis of Osteoarthritis (Killgren Lawrence Grade > III) on affected side
- Able to provide informed consent
Who cannot join
- Patients with a previous operation of the same knee, including ACL reconstruction, fracture fixation, previous arthroplasty.
- Patients that had a conversion to a different procedure intraoperatively or shortly after the TKA.
- Diagnosed with greater than Killgren Lawrence Grade II OA on the contralateral knee
- Patients that did not complete the TKA.
- Patients the Investigator deems not able to follow through with study requirements such as follow-up visits or PROM's.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida Orthopaedic Institute
Tampa, Florida, 33607
About this study
Official title: A Prospective Study Using Augmented Reality Versus Conventional Jig Controls in Total Knee Arthroplasty for Osteoarthritis
This study is a pilot analysis of a novel augmented reality guidance platform, the augmented reality visualization and information system (ARVIS, Insight Medical), with aims to demonstrate accuracy of bone resection and implant alignment during kinematic alignment total knee arthroplasty.
Read the detailed description
This study is a Randomized Controlled Trial evaluating the effectiveness of an AR system utilized to perform bone cuts when compared to traditional jigs in primary TKA for treatment of primary osteoarthritis. Our primary objective is to determine if the ARVIS augmented reality platform is a reliable tool to restore native lower extremity alignment during TKA. An estimated 50 patients will be enrolled in the study, with 25 in the AR-group and 25 in the non-AR conventional kinematic alignment group. A 20% attrition rate (10 patients) is expected throughout the study, leaving 20 patients in each study group. The Investigator intend to evaluate only patients who've met the clinical and radiographic indications for TKA for one knee (Killgren Lawrence Grade > III) and have less than Killgren Lawrence Grade II OA of the contralateral knee. The Investigators intend to use the uninvolved knee as a radiographic comparison to determine ARVIS's post-operative restorative accuracy to the patient's native alignment. Pre- and post-operative radiographs will include standing knee AP, PA, lateral, sunrise, and hip-to-ankle radiographs.
The investigators have chosen to reproduce the patient's native alignment during TKA rather than mechanical alignment given the predominance of recent literature demonstrating superior function and outcome of kinematic based techniques. Intraoperatively, the investigators will use ARVIS to prospectively record bone resection thickness, distal femoral resection angle, femoral component sagittal orientation, femoral component rotation, tibial resection thickness, coronal tibial resection angle, and tibial slope.
The ARVIS is an augmented reality headset with a heads-up display capable of presenting pre-resection hip center and lower extremity alignment. The heads-up display provides real time, intra-operative feedback during bone resections to optimize the component position and lower extremity alignment as compared to the uninvolved contralateral limb. Unlike other methods used to prepare bone cuts during TKA, such as traditional jigs or robotic systems, ARVIS is a self-contained, wearable surgical guidance device controlled by the surgeon, designed to ensure surgeon can focus on their patient while they perform bone cuts on tibia and femur - not a screen across the room.
The procedure of TKA is the same for traditional approach utilizing jigs and ARVIS approach.
ARVIS has received 510(k) clearance from the FDA as of July 2021.
- Conditions
- Osteoarthritis
- Being tested
- Evaluation of Augmented Reality technology in TKA compared to standard TKA
- Keywords
- osteoarthritis of knee, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Augmented Reality technology in TKA compared to standard TKAOther
Evaluation of effectiveness of AR system used to perform bone cuts when compared to traditional jigs in primary TKA
| Study group | Role | What they receive |
|---|---|---|
| ARVIS arm | Experimental | TKA using ARVIS software Receives: Other: Evaluation of Augmented Reality technology in TKA compared to standard TKA |
| conventional TKA | Placebo comparator | Conventional Total Knee Arthroplasty Receives: Other: Evaluation of Augmented Reality technology in TKA compared to standard TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Measurements bilateral knees
Weight bearing anterposterior (AP), lateral and sunrise views of both knees to measure tibial slope, hip-knee alignment, medial proximal tibial angle, mechanical lateral distal femoral angle, joint line convergence angle, anatomic- mechanical angle.
Measured: From enrollment until 1 year follow-up visit.
Secondary outcomes (4)
PROMIS-10 Survey
Patient Reported Outcome Measure Information System with 10 questions about subjects pain and function.
Measured: frome enrollment until 12 month final study visit
Knee Society Score (KSS)
A simple and objective scoring system to rate the knee and patient's functional abilities before and after total knee arthroplasty.
Measured: From enrollment until final visit at 12 months after surgery
Knee Injury and Osteoarthritis outcome Score (KOOS)
KOOS is a 42-item questionnaire that assesses the patient's opinion about the health, symptoms, and functionality of their knee.
Measured: from enrollment until completion of study at 12 months post surgery
Numeric Pain Rating Score (NPRS)
1-10 numeric scale that asks patients to rate their pain in the last 24 hours.
Measured: From enrollment until final study visit at 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Dec 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- DonJoy Orthopedics
- Responsible party
- Sponsor
- Investigators
- Brian Palumbo, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663384
- Sponsor's protocol ID
- FORE092024
- Acronym
- ARVIS
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot analysis of a novel augmented reality guidance platform, the augmented reality visualization and information system (ARVIS, Insight Medical), with aims to demonstrate accuracy of bone resection and implant alignment during kinematic alignment total knee arthroplasty.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Using Augmented Reality Versus Conventional Jig Controls in Total Knee Arthroplasty for Osteoarthritis
- ClinicalTrials.gov ID
- NCT06663384
- Acronym / sponsor ID
- ARVIS / FORE092024
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis of knee, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Collaborators
- DonJoy Orthopedics
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 29 Oct 2024 (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.
This study is a pilot analysis of a novel augmented reality guidance platform, the augmented reality visualization and information system (ARVIS, Insight Medical), with aims to demonstrate accuracy of bone resection and implant alignment during kinematic alignment total knee arthroplasty.
Detailed description
This study is a Randomized Controlled Trial evaluating the effectiveness of an AR system utilized to perform bone cuts when compared to traditional jigs in primary TKA for treatment of primary osteoarthritis. Our primary objective is to determine if the ARVIS augmented reality platform is a reliable tool to restore native lower extremity alignment during TKA. An estimated 50 patients will be enrolled in the study, with 25 in the AR-group and 25 in the non-AR conventional kinematic alignment group. A 20% attrition rate (10 patients) is expected throughout the study, leaving 20 patients in each study group. The Investigator intend to evaluate only patients who've met the clinical and radiographic indications for TKA for one knee (Killgren Lawrence Grade > III) and have less than Killgren Lawrence Grade II OA of the contralateral knee. The Investigators intend to use the uninvolved knee as a radiographic comparison to determine ARVIS's post-operative restorative accuracy to the patient's native alignment. Pre- and post-operative radiographs will include standing knee AP, PA, lateral, sunrise, and hip-to-ankle radiographs.
The investigators have chosen to reproduce the patient's native alignment during TKA rather than mechanical alignment given the predominance of recent literature demonstrating superior function and outcome of kinematic based techniques. Intraoperatively, the investigators will use ARVIS to prospectively record bone resection thickness, distal femoral resection angle, femoral component sagittal orientation, femoral component rotation, tibial resection thickness, coronal tibial resection angle, and tibial slope.
The ARVIS is an augmented reality headset with a heads-up display capable of presenting pre-resection hip center and lower extremity alignment. The heads-up display provides real time, intra-operative feedback during bone resections to optimize the component position and lower extremity alignment as compared to the uninvolved contralateral limb. Unlike other methods used to prepare bone cuts during TKA, such as traditional jigs or robotic systems, ARVIS is a self-contained, wearable surgical guidance device controlled by the surgeon, designed to ensure surgeon can focus on their patient while they perform bone cuts on tibia and femur - not a screen across the room.
The procedure of TKA is the same for traditional approach utilizing jigs and ARVIS approach.
ARVIS has received 510(k) clearance from the FDA as of July 2021.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARVIS arm | Experimental | Other: Evaluation of Augmented Reality technology in TKA compared to standard TKATKA using ARVIS software |
| conventional TKA | Placebo comparator | Other: Evaluation of Augmented Reality technology in TKA compared to standard TKAConventional Total Knee Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years old
- Scheduled for primary conventional TKA with kinematic alignment
- Primary Diagnosis of Osteoarthritis (Killgren Lawrence Grade > III) on affected side
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Patients with a previous operation of the same knee, including ACL reconstruction, fracture fixation, previous arthroplasty.
- Patients that had a conversion to a different procedure intraoperatively or shortly after the TKA.
- Diagnosed with greater than Killgren Lawrence Grade II OA on the contralateral knee
- Patients that did not complete the TKA.
- Patients the Investigator deems not able to follow through with study requirements such as follow-up visits or PROM's.
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 |
|---|---|---|
| Evaluation of Augmented Reality technology in TKA compared to standard TKAEvaluation of effectiveness of AR system used to perform bone cuts when compared to traditional jigs in primary TKA | Other | ARVIS arm, conventional TKA |
Primary outcome
Radiographic Measurements bilateral knees
Time frame: From enrollment until 1 year follow-up visit.
Weight bearing anterposterior (AP), lateral and sunrise views of both knees to measure tibial slope, hip-knee alignment, medial proximal tibial angle, mechanical lateral distal femoral angle, joint line convergence angle, anatomic- mechanical angle.
4 secondary outcomes
PROMIS-10 Survey
Time frame: frome enrollment until 12 month final study visit
Knee Society Score (KSS)
Time frame: From enrollment until final visit at 12 months after surgery
Knee Injury and Osteoarthritis outcome Score (KOOS)
Time frame: from enrollment until completion of study at 12 months post surgery
Numeric Pain Rating Score (NPRS)
Time frame: From enrollment until final study visit at 12 months post surgery
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 9 Sep 2026.
- Individual participant dataSharing planned: No. This is a pilot analysis of a novel augmented reality guidance platform, the augmented reality visualization and information system (ARVIS, Insight Medical), with aims to demonstrate accuracy of bone resection and implant alignment during kinematic alignment total knee arthroplasty.
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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.
Brian Palumbo, MD principal investigator
Florida Orthopaedic 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 Evaluation of Augmented Reality technology in TKA compared to standard TKA in people with Osteoarthritis, run by Foundation for Orthopaedic Research and Education 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 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. Some participants in this study may receive a placebo. 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?
Contact Debbi Warren, RN (813-910-3688, dwarren@foreonline.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Measurements bilateral knees (time frame: From enrollment until 1 year follow-up visit.). 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 9 Sep 2026.