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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Behavioral, Diagnostic test, Genetic
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Symptomatic, end-stage knee osteoarthritis

• Ligaments functionally intact

• Age: older than18 years old

Locations
Other Locations
Italy
Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITING
Rome
Contact Information
Primary
Umile Giuseppe Longo, MD, MSc, PhD
g.longo@policlinicocampus.it
+39 06225418816
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2029-12
Participants
Target number of participants: 197
Treatments
Experimental: Patients who undergo total total knee arthroplasty
The study population comprises 197 patients who require Total Knee Arthroplasty (TKA) due to symptomatic, end-stage knee osteoarthritis. Eligible participants are adults over the age of 18 years with functionally intact ligaments. Exclusion criteria include individuals with neurological or other conditions that affect their ability to participate in walking trials, those with inflammatory or infectious arthritis, previous significant knee surgeries such as articular fractures (excluding knee arthroscopy and meniscal surgery), and those with active tumors or who are pregnant. This population selection is aimed at assessing the efficacy of AI-integrated interventions in improving surgical outcomes and postoperative recovery in a homogeneous group affected by severe knee degeneration.
Sponsors
Leads: Fondazione Policlinico Universitario Campus Bio-Medico

This content was sourced from clinicaltrials.gov