ARVIS TKA vs Conventional TKA

NCT06663384 | Recruiting

• 1 other identifier: FORE092024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis

Keywords

osteoarthritis of knee, Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment until 1 year follow-up visit.

Secondary Outcomes (4)

• PROMIS-10 Survey

  frome enrollment until 12 month final study visit

• Knee Society Score (KSS)

  From enrollment until final visit at 12 months after surgery

• Knee Injury and Osteoarthritis outcome Score (KOOS)

  from enrollment until completion of study at 12 months post surgery

• Numeric Pain Rating Score (NPRS)

  From enrollment until final study visit at 12 months post surgery

Other Outcomes (1)

• Virtual Reality Sickness Questionnaire (VSRQ)

  After the surgical procedure - one time only

Study Arms (2)

ARVIS arm

EXPERIMENTAL

TKA using ARVIS software

Other: Evaluation of Augmented Reality technology in TKA compared to standard TKA

conventional TKA

PLACEBO COMPARATOR

Conventional Total Knee Arthroplasty

Other: Evaluation of Augmented Reality technology in TKA compared to standard TKA

Interventions

Evaluation of Augmented Reality technology in TKA compared to standard TKA OTHER

Evaluation of effectiveness of AR system used to perform bone cuts when compared to traditional jigs in primary TKA

ARVIS arm; conventional TKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead
• DonJoy Orthopedics: collaborator

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33607, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Brian Palumbo, MD

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debbi Warren, RN

CONTACT

813-910-3688; dwarren@foreonline.org

Peter Simon

CONTACT

312-509-5761; psimon@foreonline.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 29, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)