RecruitingNot ApplicableNCT06634654

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


Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Enrollment

197 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Symptomatic, end-stage knee osteoarthritis
  • Ligaments functionally intact
  • Age: older than18 years old

Exclusion Criteria4

  • Neurological or other conditions affecting patients ability to join walking trials
  • Inflammatory or infectious arthritis
  • Previous articular fracture or knee surgery (excluding knee arthroscopy and meniscal surgery)
  • Active tumors or pregnancy.

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Interventions

PROCEDURETotal Knee Arthroplasty

Total Knee Arthroplasty is performed using conventional surgical techniques.

DIAGNOSTIC_TESTMultifaceted diagnostic assessments

Multifaceted diagnostic assessments involving genetic analysis, biomechanical data collection, radiographic imaging, and psychological evaluations.

BEHAVIORALFollow-ups

Postoperative follow-up includes behavioral interventions, such as lifestyle counseling and rehabilitation programs, tailored based on AI-driven insights into individual patient recovery profiles.

GENETICGenetic screening

Genetic screening and analysis, including whole exome sequencing, are conducted to identify genetic markers that might influence the outcomes of knee arthroplasty. This data is utilized within AI models to predict patient-specific surgical outcomes and recovery processes.


Locations(1)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, Italy

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NCT06634654


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