NCT06634654 An Artificial Intelligence-based Approach in Total Knee Arthroplasty: From Inflammatory Responses to Personalized Medicine
| NCT ID | NCT06634654 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 197 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 197 participants in total. It began in 2024-10-14 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Symptomatic, end-stage knee osteoarthritis 2. Ligaments functionally intact 3. Age: older than18 years old Exclusion Criteria: 1. Neurological or other conditions affecting patients ability to join walking trials 2. Inflammatory or infectious arthritis 3. Previous articular fracture or knee surgery (excluding knee arthroscopy and meniscal surgery) 4. Active tumors or pregnancy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06634654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06634654 currently recruiting?
Yes, NCT06634654 is actively recruiting participants. Contact the research team at g.longo@policlinicocampus.it for enrollment information.
Where is the NCT06634654 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06634654 clinical trial?
NCT06634654 is sponsored by Fondazione Policlinico Universitario Campus Bio-Medico. The trial plans to enroll 197 participants.