Understanding knee tissue health and movement
Analysis of the Pathophysiological and Functional State of the Knee Joint
This project will use MRI and gait analysis to see if detailed imaging and movement testing can better characterize knee pain and early cartilage damage in people with mild-to-moderate osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06490770 on ClinicalTrials.gov |
What this trial studies
This interventional protocol combines advanced, tissue-specific MRI sequences with gait analysis to characterize the pathophysiological and functional state of the knee joint. Eligible participants have knee pain or reduced function with Kellgren-Lawrence grade ≤2 and arthroscopic evidence of cartilage lesions. The protocol excludes people with prior partial or total knee replacement and those with contraindications to MRI or electrical stimulation. All procedures are performed in person at a single center using imaging and biomechanical measures to link tissue changes with functional impairment.
Who should consider this trial
Good fit: Adults with knee pain or loss of function, Kellgren-Lawrence grade ≤2, and arthroscopic evidence of cartilage lesions who can safely undergo MRI and attend in-person gait testing are ideal candidates.
Not a fit: Patients with prior partial or total knee prostheses, advanced radiographic osteoarthritis (KL >2), or medical contraindications to MRI or electrical stimulation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could help detect early tissue and functional changes so clinicians can target treatments earlier and personalize care to slow progression and reduce disability.
How similar studies have performed: Combining MRI tissue imaging with gait analysis has been used in prior work to characterize osteoarthritis, but reproducible predictive biomarkers for progression remain limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: stefano zaffagnini
- Email: stefano.zaffagnini@unibo.it
- Phone: +390516366075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.