Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634654
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
An Artificial Intelligence-based Approach in Total Knee Arthroplasty from Inflammatory Responses to Personalized Medicine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Artificial Intelligence-based Approach in Total Knee Arthroplasty from Inflammatory Responses to Personalized Medicine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AI-TKA
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
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
Detailed Description:
Osteoarthritis is one of the most common causes of knee disorders leading to pain reduced mobility and a decline in quality of life Total knee arthroplasty TKA is one of the most established treatments for end-stage osteoarthritis Despite advancements in surgical techniques patient dissatisfaction remains high After surgery patients often experience swelling pain and difficulty with daily activities Revision surgery is a major challenge with aseptic loosening occurring in 15-20 of cases Given the high disability rates and healthcare costs associated with TKA optimizing patient care is crucial
Artificial intelligence AI offers the potential to identify new care profiles For the first time AI can integrate multimodal datasets This approach could lead to personalized treatment for knee osteoarthritis patients in line with precision medicine principles This study takes a multidisciplinary approach to better understand the causes of failure and dissatisfaction following TKA
The primary aim of this study is is to create a multimodal database This database will include structural genetic biomechanical clinical psychological biological stress-related inflammatory and demographic data Using AI the study aims to build predictive models for post-TKA outcomes Insights from this research could improve patient management and lead to new therapeutic approaches
Patients suffering from knee osteoarthritis at Fondazione Policlinico Universitario Campus Bio-Medico will be enrolled in this study if they meet the inclusionexclusion criteria described above
There are no risks for the patients recruited in the study The total duration of the study is 5 years The enrolment of patients will start on the 01102024 and will last 12 months for each patient
The Italian Ministry of Health and the Fondazione Policlinico Universitario Campus Bio-Medico supported this study
The PI and also the main contact of this study is professor Umile Giuseppe Longo
Artificial intelligence AI offers the potential to identify new care profiles For the first time AI can integrate multimodal datasets This approach could lead to personalized treatment for knee osteoarthritis patients in line with precision medicine principles This study takes a multidisciplinary approach to better understand the causes of failure and dissatisfaction following TKA
The primary aim of this study is is to create a multimodal database This database will include structural genetic biomechanical clinical psychological biological stress-related inflammatory and demographic data Using AI the study aims to build predictive models for post-TKA outcomes Insights from this research could improve patient management and lead to new therapeutic approaches
Patients suffering from knee osteoarthritis at Fondazione Policlinico Universitario Campus Bio-Medico will be enrolled in this study if they meet the inclusionexclusion criteria described above
There are no risks for the patients recruited in the study The total duration of the study is 5 years The enrolment of patients will start on the 01102024 and will last 12 months for each patient
The Italian Ministry of Health and the Fondazione Policlinico Universitario Campus Bio-Medico supported this study
The PI and also the main contact of this study is professor Umile Giuseppe Longo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None