Osteoarthritis, KneeGait-MRI-KneeNCT06490770
Analysis of the Pathophysiological and Functional State of the Knee Joint
A study testing Gait analysis, Magnetic Resonance Imaging in people with Osteoarthritis, Knee and Cartilage Degeneration, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteoarthritis, Knee, Cartilage Degeneration
- What is being tested?
- Gait analysis, Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jul 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Stefano Zaffagnini, MD, +39 051 6366075, stefano.zaffagnini@ior.it
About this study
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.
Read more
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
- Being tested
- Gait analysis, Magnetic Resonance Imaging
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysis, Magnetic Resonance ImagingDiagnostic test
Gait analysis and Magnetic Resonance Imaging to investigate the functionality and the pathological condition of the knee, respectively
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | Not described Receives: Diagnostic Test: Gait analysis, Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and 12-month follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start9 Jul 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490770
- Sponsor's protocol ID
- Gait-MRI-Knee
- Acronym
- Gait-MRI-Knee
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Pathophysiological and Functional State of the Knee Joint
- ClinicalTrials.gov ID
- NCT06490770
- Acronym / sponsor ID
- Gait-MRI-Knee / Gait-MRI-Knee
- Conditions
- Osteoarthritis, Knee, Cartilage Degeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Diagnostic Test: Gait analysis, Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait analysis, Magnetic Resonance ImagingGait analysis and Magnetic Resonance Imaging to investigate the functionality and the pathological condition of the knee, respectively | Diagnostic test | group 1 |
Primary outcome
Magnetic Resonance Imaging
Time frame: at baseline and 12-month follow-up
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.
4 secondary outcomes
Strength measurements with a manual dynamometer
Time frame: at baseline and 12-month follow-up
Bioimpedance analysis
Time frame: at baseline and 12-month follow-up
Gait Analysis (including Electromyography)
Time frame: at baseline and 12-month follow-up
Clinical questionnaires
Time frame: at baseline and 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis, Magnetic Resonance Imaging in people with Osteoarthritis, Knee and Cartilage Degeneration, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact stefano zaffagnini (+390516366075, stefano.zaffagnini@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (time frame: at baseline and 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.