Clinical trial NCT06634654: An Artificial Intelligence-based Approach in Total Knee Arthroplasty: From Inflammatory Responses to Personalized Medicine
Official title: An Artificial Intelligence-based Approach in Total Knee Arthroplasty: From Inflammatory Responses to Personalized Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Artificial Intelligence
Total Knee Arthroplasty
Biomechanics
Orthopaedic surgery
Alarmins
Oxidative Stress
Cytokine
Knee Inflammation
Knee Osteoarthritis
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 inclusion/exclusion 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 01/10/2024 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.

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.

Primary outcomes:
measure: Change From Baseline in Knee Society Score (KSS) at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change From Baseline in Oxford Knee Score (OKS) at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change From Baseline in Forgotten Joint Score Short Form (FJS-12) at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
Secondary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in knee range of motion (ROM) at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in ground reaction forces at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in center of pressure (CoP) at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in walking speed at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in cadence at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in Step and Stride Length at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in osteoarthritis (OA) severity based on the Kellgren-Lawrence score at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in joint alignment at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in lateral distal femoral angle at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in medial proximal tibial angle at 12 months
timeFrame: Baseline (before surgery) and 12 months postoperatively
measure: Change from baseline in joint line convergence angle at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change from baseline in tibial slope at 12 months
timeFrame: Before surgery (Baseline) and at 12 months postoperatively
measure: Change From Baseline in the fecal microbiota profiles at 12 months
timeFrame: Before surgery and at 12 months postoperatively
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
Study officials:
References: