Analysis of the Pathophysiological and Functional State of the Knee Joint
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Bologna, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 25 people, planned
- Started
- 9 Jul 2025
- Expected to end
- Apr 2027
- Type of study
- Interventional
- Treatments tested
- Gait analysis, Magnetic Resonance Imaging
- Record updated
- 2 July 2026
Who can take part
- Age
- 18 years to 60 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- History/evidence of previous partial or total knee prosthesis interventions
- 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)
- Inability to provide informed consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Where in Italy
- IRCCS Istituto ortopedico RizzoliBologna, ItalyContact: Stefano Zaffagnini, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- group 1Other group
Treatment: Gait analysis, Magnetic Resonance Imaging
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06490770, who can take part
- Record updated
- 2 July 2026