NCT06663384 · Foundation for Orthopaedic Research and Education
ARVIS TKA vs Conventional TKA
(ARVIS)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Evaluation of Augmented Reality technology in TKA compared to standard TKA
Evaluation of effectiveness of AR system used to perform bone cuts when compared to traditional jigs in primary TKA
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where
- Tampa, Florida
Collaborators
DonJoy Orthopedics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 9, 2024 · Source of record for eligibility and locations