NCT06490770 Analysis of the Pathophysiological and Functional State of the Knee Joint
| NCT ID | NCT06490770 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-07-09 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-07-09 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06490770 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06490770 currently recruiting?
Yes, NCT06490770 is actively recruiting participants. Contact the research team at stefano.zaffagnini@unibo.it for enrollment information.
Where is the NCT06490770 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06490770 clinical trial?
NCT06490770 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 25 participants.