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

Condition(s) studied

Investigational drug(s) / intervention(s)

Total Knee Arthroplasty: Total Knee Arthroplasty is performed using conventional surgical techniques.

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

Follow-ups: Postoperative 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: 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.

Study 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

Primary outcome measure(s)

• Change From Baseline in Knee Society Score (KSS) at 12 months — Before surgery (Baseline) and at 12 months postoperatively
  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 — Before surgery (Baseline) and at 12 months postoperatively
  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 — Before surgery (Baseline) and at 12 months postoperatively
  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 — Before surgery (Baseline) and at 12 months postoperatively
  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

Trial sites (1)

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