Analysis of the Pathophysiological and Functional State of the Knee Joint

NCT06490770 | Recruiting

• 1 other identifier: Gait-MRI-Knee
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Cartilage Degeneration

Outcome Measures

Primary Outcomes (1)

• Magnetic Resonance Imaging

  MRI images will be acquired for each subject using a high-field scanner (3T, Discovery MR750w3, GE Healthcare, UK) with sequences that will allow i) the analysis of the pathophysiological state of the knee cartilage, and ii) the identification and segmentation of the various leg muscles. Regarding the investigation of joint tissues, quantitative sequences (e.g., T2 mapping) will be acquired using a specific coil, according to standard practice. MRI images related to the muscular aspects of the entire lower limb will be added to the previous ones-which will instead be focused on the region bounded by the femoral and tibial diaphyses-in order to obtain complete information in a single acquisition session with additional timing on the order of minutes. MRI images at the 12-month follow-up are specific to the study.

  at baseline and 12-month follow-up

Secondary Outcomes (4)

• Strength measurements with a manual dynamometer

  at baseline and 12-month follow-up

• Bioimpedance analysis

  at baseline and 12-month follow-up

• Gait Analysis (including Electromyography)

  at baseline and 12-month follow-up

• Clinical questionnaires

  at baseline and 12-month follow-up

Study Arms (1)

group 1

OTHER

Diagnostic Test: Gait analysis, Magnetic Resonance Imaging

Interventions

Gait analysis, Magnetic Resonance Imaging DIAGNOSTIC_TEST

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

group 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Gait Analysis; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics; Tomography; Diagnostic Imaging

Central Study Contacts

stefano zaffagnini

CONTACT

+390516366075; stefano.zaffagnini@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 8, 2024
• Study Start: July 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-05

Locations

IT (1)