Comparing augmented reality guidance to traditional methods in knee replacement surgery
A Prospective Study Using Augmented Reality Versus Conventional Jig Controls in Total Knee Arthroplasty for Osteoarthritis
This study is testing if using a new augmented reality system during knee replacement surgery helps patients with osteoarthritis have better results than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Foundation for Orthopaedic Research and Education Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06663384 on ClinicalTrials.gov |
What this trial studies
This pilot analysis evaluates the effectiveness of an augmented reality guidance platform, ARVIS, in performing total knee arthroplasty (TKA) for patients with osteoarthritis. The study is a randomized controlled trial involving 50 patients, divided into two groups: one using the ARVIS system and the other using conventional methods. The primary goal is to assess the accuracy of bone resection and implant alignment during surgery, with a focus on restoring the patient's native lower extremity alignment. Pre- and post-operative radiographs will be analyzed to determine the effectiveness of the ARVIS system compared to traditional techniques.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for primary total knee arthroplasty due to osteoarthritis with significant joint degeneration.
Not a fit: Patients with prior knee surgeries or those with severe osteoarthritis in the contralateral knee may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and enhanced recovery for patients undergoing knee replacement surgery.
How similar studies have performed: While the use of augmented reality in surgery is emerging, this specific application in TKA is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 1. Patients with a previous operation of the same knee, including ACL reconstruction, fracture fixation, previous arthroplasty. 2. Patients that had a conversion to a different procedure intraoperatively or shortly after the TKA. 3. Diagnosed with greater than Killgren Lawrence Grade II OA on the contralateral knee 4. Patients that did not complete the TKA. 5. Patients the Investigator deems not able to follow through with study requirements such as follow-up visits or PROM's.
Where this trial is running
Tampa, Florida
- Florida Orthopaedic Institute — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Brian Palumbo, MD — Florida Orthopaedic Institute
- Study coordinator: Debbi Warren, RN
- Email: dwarren@foreonline.org
- Phone: 813-910-3688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.