An interventional study of Gait analysis, Magnetic Resonance Imaging in Osteoarthritis, Knee and Cartilage Degeneration, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Diagnostic
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Among 31 studies in Osteoarthritis, Knee by Istituto Ortopedico Rizzoli — 13 open to participants now, 13 under way, none of them phase 3. Osteoarthritis, Knee · Istituto Ortopedico Rizzoli.
Among the 31 studies in Osteoarthritis, Knee by Istituto Ortopedico Rizzoli, this one is the 19th largest by planned enrollment of the 25 interventional ones that give a count, is one of 3 that started in 2025, is one of 21 with no phase, reaches primary completion later than 9 of the 12 other live ones, and was the 26th registered.
3,294 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
Browse Osteoarthritis, Knee studies →13 of the 31 studies in Osteoarthritis, Knee by Istituto Ortopedico Rizzoli are open now, in 1 country. Recruiting first, the newest first:
Istituto Ortopedico Rizzoli · Sites in Italy
Ages 40–65
Istituto Ortopedico Rizzoli · Sites in Italy
Ages 65–80
Istituto Ortopedico Rizzoli · Sites in Italy
Ages 18–85
Istituto Ortopedico Rizzoli · Sites in Italy
Ages 40–75
Istituto Ortopedico Rizzoli · Sites in Italy
Ages 18–40
By country, each count listing its studies:
Of the 383 Osteoarthritis, Knee studies recruiting now, 177 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
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31 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 25 is below the median of 68 across 2,716 interventional studies indexed under Osteoarthritis, Knee.
Median enrollment 50 across the 25 interventional studies, 105 across the 6 observational. Of the 18 that completed or were terminated, 0 (0%) have results posted.
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Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
4 of the studies in Osteoarthritis, Knee by Istituto Ortopedico Rizzoli that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06726629Istituto Ortopedico RizzoliCrosscultural Adaptation And Validation Of The Italian Version Of The New Knee Society Knee Scoring System | 2026-11 |
| NCT06251752Istituto Ortopedico RizzoliLong Term Evaluation of Clinical and Radiologic Results on Femoro-patellar Joint After High Tibial Osteotomy | 2026-12 |
| NCT06040957Istituto Ortopedico RizzoliBone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis | 2027-01 |
| NCT06490770Istituto Ortopedico RizzoliAnalysis of the Pathophysiological and Functional State of the Knee Joint | 2027-04 |
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Among the 31 studies in Osteoarthritis, Knee by Istituto Ortopedico Rizzoli, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: at baseline and 12-month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline and 12-month follow-up
Started Jul 2025 (actual). Primary completion is estimated for Apr 2027, 21 months after the start.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 21 months is above that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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