Clinical Trial

An Artificial Intelligence-based Approach in Total Knee Arthroplasty: From Inflammatory Responses to Personalized Medicine

Study acronym: AI-TKA
Recruiting
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Record status
This record was last updated March 4, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
Goal: The goal of this interventional study is to understand how multimodal preoperative data can predict outcomes after Total Knee Arthroplasty (TKA) and improve personalized medicine practices. Participant Population: The study will enroll 197 patients suffering from symptomatic, end-stage knee osteoarthritis, who are above 18 years old and have functionally intact ligaments. Main Questions: * Can multimodal preoperative data, genetic predisposition, and psycho-behavioral characteristics predict outcomes after TKA? * Can AI models effectively use this data to customize prostheses and surgical interventions, and predict patient outcomes? Comparison Group Information (If applicable): Not specified in the provided details. Participant Tasks: * Undergo TKA as per the normal clinical routine. * Participate in pre- and post-surgical follow-ups including: * Clinical-functional assessments. * Administration of clinical scores. * Collection of biological samples. * Biomechanical analysis using a stereophotogrammetric system. * Provide data for the comprehensive multimodal indexed database.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-10-04; most recent amendment 2026-03-02.
Status change: Not Yet Recruiting → Recruiting 2025-02-19
Trial Details
NCT Number NCT06634654
Lead Sponsor Fondazione Policlinico Universitario Campus Bio-Medico
Conditions Knee Osteoarthritis
Enrollment 197 participants
Start Date 2024-10-14
Primary Completion 2026-06 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-04