Analysis of the Pathophysiological and Functional State of the Knee Joint

Overview

Osteoarthritis is the most common degenerative condition affecting the knee joint globally, with an incidence of about 7% of the population. In Italy, it affects approximately 3.9 million people, with a direct treatment cost of around €2.5 billion. At the joint level, osteoarthritis manifests with pain and reduced functionality, worsening as the disease progresses and severely limiting knee movement. Compounding this, osteoarthritis can impact both elderly and younger individuals due to traumatic factors. Despite its significant impact, effective treatments for osteoarthritis that address its underlying causes are still lacking, focusing mainly on symptom management. Therefore, improving diagnostic and prognostic approaches is crucial to better understand its onset and progression. MRI is a primary diagnostic tool for assessing the knee joint's pathophysiological state. It uses tissue-specific sequences to investigate joint homeostasis in detail, although it primarily provides insights into morphology, structure, and tissue composition rather than functional changes within the joint. This limitation is noteworthy because joint homeostasis involves complex interactions among biomechanical, structural, and biological processes, which are directly influenced by osteoarthritis. Gait analysis provides valuable diagnostic information on joint function. By integrating sensor measurements and electronic systems with patient-specific musculoskeletal models derived from MRI morphometric data, it is possible to assess the forces and moments within the joint during specific movements. Given that osteoarthritis affects the entire joint, employing multidisciplinary approaches can enhance diagnostic precision and provide insights into the progressive impact of degenerative conditions like osteoarthritis on joint health.

Interventions

• Diagnostic test Gait analysis, Magnetic Resonance Imaging
  Gait analysis and Magnetic Resonance Imaging to investigate the functionality and the pathological condition of the knee, respectively

Primary outcome measures

• Magnetic Resonance Imaging [Time frame: at baseline and 12-month follow-up]

Secondary outcome measures (4)

• Strength measurements with a manual dynamometer [Time frame: at baseline and 12-month follow-up]
• Bioimpedance analysis [Time frame: at baseline and 12-month follow-up]
• Gait Analysis (including Electromyography) [Time frame: at baseline and 12-month follow-up]
• Clinical questionnaires [Time frame: at baseline and 12-month follow-up]

Eligibility criteria

Inclusion criteria

• Knee pain and/or loss of functionality
• Kellgren-Lawrence grade less than or equal to 2
• Arthroscopic evidence of cartilage tissue lesions
• Evidence of cartilage and/or meniscal tissue degeneration and/or subchondral bone marrow lesions

Exclusion criteria

• History/evidence of previous partial or total knee prosthesis interventions
• Inability to provide informed consent
• Conditions or physical disorders incompatible with the use of MRI and electrical stimulation (implanted active and passive biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Italy · 1 center

• IRCCS Istituto Ortopedico Rizzoli — Bologna

Identifiers

NCT: NCT06490770 · Gait-MRI-Knee

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗