Comparing augmented reality guidance to traditional methods in knee replacement surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.