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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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17 August 2021 |
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Main ID: |
NCT03110679 |
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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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Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
OA-bi-Blind |
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Scientific title:
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Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid |
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Date of first enrolment:
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May 23, 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03110679 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female patients, aged between 18 and 75 years;
2. Bilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1-4);
3. Failure after two months of conservative treatment;
4. Capacity and consent of patients to participate actively in the rehabilitation
protocol, follow-up clinic and radiology protocol;
5. Signature of informed consent.
Exclusion Criteria:
1. Patients incapable of discernment;
2. Patients with malignancy
3. Patients with rheumatic diseases;
4. Patients with diabetes;
5. Patients with metabolic disorders of the thyroid;
6. Patients belonging abuse of alcohol, drugs or medications;
7. Patients with misalignment of the lower limbs than 10 °;
8. Body Mass Index> 40;
9. Patients with a history of trauma or intra-articular infiltration of therapeutic
substances within 6 months prior to treatment.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis, Knee
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Intervention(s)
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Biological: injection of autologous bone marrow concentrate
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Biological: injection of hyaluronic acid.
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Primary Outcome(s)
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International Knee Documentation Committee (IKDC)-Subjective score
[Time Frame: Time Frame: 6 months]
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Secondary Outcome(s)
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International Knee Documentation Committee (IKDC)-Subjective score
[Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation]
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Knee Injury and Osteoarthritis Outcome Score (KOOS).
[Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation]
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Secondary ID(s)
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OA-bi-Blind
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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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