Status:
RECRUITING
Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The MAST-GR study is a randomized controlled interventional trial with parallel treatment arms and 1:1 allocation The primary objective of the study is to compare the safety and efficacy of a single ...
Detailed Description
Patients with symptomatic unilateral knee OA will be included in a randomized controlled Trial (RCT), in which one group of patients will be treated with 1 intra-articular infiltration of BMAC, and on...
Eligibility Criteria
Inclusion
- Patients with symptomatic unilateral knee OA with:
- Men or women aged 40 to 75 years;
- Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months;
- Radiographic signs of OA (Kellgren-Lawrence grade 1-4);
- No benefit after at least 4 months of conservative treatment;
- Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up;
- Signing of informed consent.
Exclusion
- Patients unable to express consent;
- Patients aged \< to 40 and \> to 75 years;
- Patients with axial deviations \> 5°;
- Patients who have suffered trauma or undergone intra-articular infiltration of other substance in the previous 6 months;
- Patients who have undergone knee surgery in the previous 12 months;
- Patients with concomitant knee injuries causing joint pain or swelling (-focal full-thickness osteochondral defects, acute meniscal injuries);
- Patients with malignant neoplasms;
- Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases);
- Patients with infectious diseases;
- Patients with histories of alcohol or drug abuse;
- Patients who are pregnant;
- Patients with allergies to anesthetics used in the procedure.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06040957
Start Date
January 8 2024
End Date
January 1 2027
Last Update
February 18 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136