Status:
COMPLETED
Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-70 years
Phase:
PHASE3
Brief Summary
Osteoarthritis (OA) is one of the most common diseases resulting in large burdens on society. Among the emerging treatments, Bone Marrow Concentrate (BMC) intra-articular injections are a promising r...
Detailed Description
The main aim is to evaluate in a RCT the potential of a new combined BMC treatment for OA, through the use of scores for the clinical outcome, the study of imaging and biological samples for tissue re...
Eligibility Criteria
Inclusion
- Male or female patients, aged between 40 and 70;
- Arthrosis of the medial compartment (grade 2-3 according to the Kellgren-Lawrence score\> 4 months);
- Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, PRP);
- Patients' ability and consent to participate in clinical and radiological follow-up;
- Signature of informed consent.
Exclusion
- Patients with trauma in the 6 months prior to surgery;
- Patients with maligncy;
- Patients suffering from rheumatic diseases;
- Patients suffering from non-compensated diabetes;
- Patients suffering from uncompensated thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or drugs;
- Patients with axial deviations\> 5 °;
- Body Mass Index\> 35;
- Patients treated with joint infiltrations in the previous 6 months;
- Patients treated with surgery at the same knee in the previous 12 months.
Key Trial Info
Start Date :
November 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03876795
Start Date
November 8 2019
End Date
March 1 2023
Last Update
April 19 2023
Active Locations (1)
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1
Rizzoli Orthopaedic Institute
Bologna, Italy, 40136