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

NCT06634654 | Recruiting

• 2 other identifiers: 179.24 CET2 cbmPNRR-MCNT2-2023-12378237
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Artificial Intelligence; Total Knee Arthroplasty; Biomechanics; Orthopaedic surgery; Alarmins; Oxidative Stress; Cytokine; Knee Inflammation; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Knee Society Score (KSS) at 12 months

  The KSS is a clinician-based assessment tool that evaluates both knee function and functional activities after knee replacement surgery. Minimum/Maximum Values: The KSS is divided into two parts: knee score and function score, with a combined score ranging from 0 to 100. Higher scores indicate a better outcome in terms of knee function and overall knee health.

  Before surgery (Baseline) and at 12 months postoperatively

• Change From Baseline in Oxford Knee Score (OKS) at 12 months

  The OKS is used to assess pain and function in individuals undergoing knee surgery or experiencing knee osteoarthritis, focusing on the patient\'s perspective. Minimum/Maximum Values: The OKS ranges from 0 to 48. Higher scores represent a better outcome, with less pain and better joint function.

  Before surgery (Baseline) and at 12 months postoperatively

• Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months

  The KOOS is widely used to evaluate short- and long-term patient-reported outcomes following knee injury or surgery. Minimum/Maximum Values: The KOOS assesses five dimensions: pain, symptoms, function in daily living, function in sports/recreation, and knee-related quality of life. Each subscale ranges from 0 to 100. Higher scores reflect a better outcome, indicating fewer symptoms and better function.

  Before surgery (Baseline) and at 12 months postoperatively

• Change From Baseline in Forgotten Joint Score Short Form (FJS-12) at 12 months

  The FJS-12 measures how much a patient is aware of their joint in daily activities, particularly after joint replacement surgery, with higher scores reflecting greater joint integration. Minimum/Maximum Values: The FJS-12 ranges from 0 to 100. High scores indicate good outcomes

  Before surgery (Baseline) and at 12 months postoperatively

Secondary Outcomes (14)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months

  Before surgery (Baseline) and at 12 months postoperatively

• Change from baseline in knee range of motion (ROM) at 12 months

  Before surgery (Baseline) and at 12 months postoperatively

• Change from baseline in ground reaction forces at 12 months

  Before surgery (Baseline) and at 12 months postoperatively

• Change from baseline in center of pressure (CoP) at 12 months

  Before surgery (Baseline) and at 12 months postoperatively

• Change from baseline in walking speed at 12 months

  Before surgery (Baseline) and at 12 months postoperatively

Study Arms (1)

Patients who undergo total total knee arthroplasty

EXPERIMENTAL

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.

Procedure: Total Knee Arthroplasty; Diagnostic Test: Multifaceted diagnostic assessments; Behavioral: Follow-ups; Genetic: Genetic screening

Interventions

Follow-ups BEHAVIORAL

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

Patients who undergo total total knee arthroplasty

Genetic screening GENETIC

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.

Patients who undergo total total knee arthroplasty

Total Knee Arthroplasty PROCEDURE

Total Knee Arthroplasty is performed using conventional surgical techniques.

Patients who undergo total total knee arthroplasty

Multifaceted diagnostic assessments DIAGNOSTIC_TEST

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

Patients who undergo total total knee arthroplasty

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, 00128, Italy

RECRUITING

Related Publications (1)

• Spallone G, Mancini L, Carnevale A, Campi S, Schena E, D'Hooghe P, Hirschmann MT, Papalia R, Longo UG. Joint modeling and marker set selection significantly influence functional biomechanics in end-stage knee osteoarthritis: evidence from the sit-to-stand task. Front Bioeng Biotechnol. 2025 Oct 13;13:1677244. doi: 10.3389/fbioe.2025.1677244. eCollection 2025.

  PMID: 41158195 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee; Lost to Follow-Up; Genetic Testing

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Central Study Contacts

Umile Giuseppe Longo, MD, MSc, PhD

CONTACT

+39 06225418816; g.longo@policlinicocampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 10, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)