RECRUITING

ARVIS TKA vs Conventional TKA

Conditions

Osteoarthritis osteoarthritis of knee, Total Knee Replacement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Prospective Study Using Augmented Reality Versus Conventional Jig Controls in Total Knee Arthroplasty for Osteoarthritis

Quick Facts

Study Start:2024-12-01

Study Completion:2027-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06663384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Debbi Warren, RN

CONTACT

813-910-3688

dwarren@foreonline.org

Peter Simon

CONTACT

312-509-5761

psimon@foreonline.org

Principal Investigator

Brian Palumbo, MD

PRINCIPAL_INVESTIGATOR

Florida Orthopaedic Institute

Study Locations (Sites)

Florida Orthopaedic Institute

Tampa, Florida, 33607

United States

Collaborators and Investigators

Sponsor: Foundation for Orthopaedic Research and Education

Brian Palumbo, MD, PRINCIPAL_INVESTIGATOR, Florida Orthopaedic Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01

Study Completion Date2027-11-01

Study Record Updates

Study Start Date2024-12-01

Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

osteoarthritis of knee, Total Knee Replacement

Additional Relevant MeSH Terms

Osteoarthritis