Analysis of the Pathophysiological and Functional State of the Knee Joint (Gait-MRI-Knee)

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Cartilage Degeneration
• Intervention / Treatment: Diagnostic test: Gait analysis, Magnetic Resonance Imaging

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: stefano zaffagnini; Phone Number: +390516366075; Email: stefano.zaffagnini@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • IRCCS Istituto Ortopedico Rizzoli
    • Contact: Stefano Zaffagnini, MD; Phone Number: +39 051 6366075; Email: stefano.zaffagnini@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength measurements with a manual dynamometer	As per clinical practice, before gait analysis, muscle strength (generalized, not specific to the knee flexor and extensor muscles) will be measured through the execution of a hand grip test with a manual hydraulic dynamometer (Jamar, Sammons Preston Rolyan, USA). The measurement will be repeated three times, allowing a 1-minute rest between repetitions.	at baseline and 12-month follow-up
Bioimpedance analysis	Patients will be asked to undergo a bioimpedance measurement (BIA BIVA 101 PRO, Akern, ITA) to estimate the muscle mass (residual) and fat mass for both lower limbs.	at baseline and 12-month follow-up
Gait Analysis (including Electromyography)	Gait analysis with electromyographic signal acquisition will be performed. Anthropometric measurements will be taken, and retroreflective markers will be placed on anatomical landmarks. Bipolar electrodes will be positioned on key lower limb muscles according to SENIAM guidelines. The test includes static calibration, walking, sit-to-stand-to-sit, and step-over tasks. Electromyographic signals will be monitored and analyzed for muscle activation and co-activation. The session will last 40-60 minutes and is study-specific.	at baseline and 12-month follow-up
Clinical questionnaires	Knee function and pain will be assessed using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) and KOOS (Knee Injury and Osteoarthritis Outcome Score) scales. WOMAC is a self-assessment questionnaire with 24 questions divided into three subgroups evaluating knee pain, joint stiffness, and functionality during daily activities. KOOS evaluates symptoms, pain, daily activities, sports activities, and quality of life. A dedicated data collection form will be used to gather all clinical information and study results. For each patient, a paper Case Report Form (CRF) will be completed. Additionally, all collected experimental data will be saved in a specially created folder on the Institute's secure server.	at baseline and 12-month follow-up

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Gait-MRI-Knee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No