NCT06383936 FAldini Sport Total Joint Arthroplasty-Knee II
| NCT ID | NCT06383936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-26 |
| Primary Completion | 2025-12-31 |
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 20 participants in total. It began in 2025-04-26 with a primary completion date of 2025-12-31.
⚠ 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
The majority of patients undergoing total knee arthroplasty are elderly individuals with low functional demands, aiming to alleviate pain. However, there exists a subgroup of younger patients, under the age of 65, with higher functional demands. The purpose of this study is to evaluate the return to sports activities in this patient group following a non-cemented total knee arthroplasty procedure and a specific rehabilitation protocol. The investigators expect that with the use of non-cemented prostheses and a specific rehabilitation protocol, many of these patients will safely resume sports activities.
Eligibility Criteria
Inclusion Criteria: * aged between 40 and 65 years, * both men and women, * individuals who engaged in sports until knee pathology hindered them. - "Saltin-Grimby Physical Activity Level Scale" 3 or 4. Exclusion Criteria: * Patients with rheumatic and/or neuromuscular disorders. * Patients with extreme knee deformity. * Patients with secondary osteoarthritis with compromised bone quality. * Patients with coronal knee instability. * Pregnant patients. * Patients with medical conditions or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs).
Frequently Asked Questions
Who can join the NCT06383936 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 65 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06383936 currently recruiting?
Yes, NCT06383936 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituto Ortopedico Rizzoli to inquire about joining.
Where is the NCT06383936 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06383936 clinical trial?
NCT06383936 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 20 participants.