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.
Symptomatic, end-stage knee osteoarthritis
Ligaments functionally intact
Age: older than18 years old
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.
Single group
Total Knee Arthroplasty
Procedure/SurgeryTotal Knee Arthroplasty is performed using conventional surgical techniques.
Multifaceted diagnostic assessments
Diagnostic testMultifaceted diagnostic assessments involving genetic analysis, biomechanical data collection, radiographic imaging, and psychological evaluations.
Follow-ups
BehavioralPostoperative follow-up includes behavioral interventions, such as lifestyle counseling and rehabilitation programs, tailored based on AI-driven insights into individual patient recovery profiles.
Genetic screening
GeneticGenetic 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.
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.
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.
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.
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
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months
The WOMAC is commonly used to evaluate pain, stiffness, and physical function in patients with osteoarthritis, particularly in the knee and hip. Minimum/Maximum Values: The WOMAC ranges from 0 to 96. High scores indicate best functional status level
Change from baseline in knee range of motion (ROM) at 12 months
Knee joint ROM (measured in degree) will be assessed during gait using a 3D motion capture system
Change from baseline in ground reaction forces at 12 months
Ground reaction forces (measured in Newtons) during gait will be measured using force platforms synchronized with the 3D motion capture system
Change from baseline in center of pressure (CoP) at 12 months
The CoP (measured in meters) will be measured during gait using force platforms synchronized with the 3D motion capture system
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