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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 June 2022 |
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Main ID: |
NCT03110666 |
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Date of registration:
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30/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study
IOC-target |
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Scientific title:
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Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study |
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Date of first enrolment:
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November 14, 2016 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03110666 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Elizaveta Kon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rizzoli Orthopedic Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age ranging from 40 to 75
- Osteoarthritis of the medial or lateral compartment (2-3-4 grade according to the
Kellgren-Lawrence score);
- Failure after at least 6 months of conservative treatment (drug therapy with
NSAIDs,hyaluronic acid,platelet-rich plasma and corticosteroids injections);
- Signature of informed consent.
Exclusion Criteria:
- Patients with trauma in the 6 months prior to the intervention;
- Patients with malignancies;
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients suffering from metabolic disorders of the thyroid;
- Patients being abuse of alcohol, drugs or medications;
- Body Mass Index> 35;
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Knee Osteoarthritis
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Intervention(s)
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Biological: Injection of autologous concentrated bone marrow aspirate
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Primary Outcome(s)
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improvement of the International Knee Documentation Committee (IKDC) subjective score
[Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation]
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Secondary Outcome(s)
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improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)
[Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation]
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evaluation of WORMS score for MRI
[Time Frame: Time Frame: 6, 12, 24 months evaluation]
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Secondary ID(s)
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IOC-target
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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