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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ClinicalTrials.gov Identifier: NCT03110679 |
Recruitment Status :
Recruiting
First Posted : April 12, 2017
Last Update Posted : February 15, 2021
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Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis, Knee | Biological: injection of autologous bone marrow concentrate Biological: injection of hyaluronic acid. | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | autologous bone marrow concentrate vs. hyaluronic acid. |
Masking: | Double (Participant, Investigator) |
Masking Description: | cover the syringe to mask the contents |
Primary Purpose: | Treatment |
Official Title: | Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid |
Actual Study Start Date : | February 18, 2016 |
Estimated Primary Completion Date : | February 2021 |
Estimated Study Completion Date : | February 2021 |

Arm | Intervention/treatment |
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Experimental: autologous bone marrow concentrate
concentration of bone marrow taken from the patient's right tibia using Bio-MAC® suction catheter, company Biologic Therapies, Inc., and concentrated by centrifuge Bio.SPINTM Magellan®, company Biologic Therapies , Inc., and its injection in the intra-articular.
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Biological: injection of autologous bone marrow concentrate |
Experimental: hyaluronic acid.
single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control.
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Biological: injection of hyaluronic acid. |
- International Knee Documentation Committee (IKDC)-Subjective score [ Time Frame: Time Frame: 6 months ]Clinical improvement, measured by the change in scores IKDC Subjective
- International Knee Documentation Committee (IKDC)-Subjective score [ Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation ]Stability of the initial clinical improvement between 6 and 24 months
- Knee Injury and Osteoarthitis Outcome Score (KOOS). [ Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation ]Stability of the initial clinical improvement between 6 and 24 months of the KOOS pain score

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female patients, aged between 18 and 75 years;
- Bilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1-4);
- Failure after two months of conservative treatment;
- Capacity and consent of patients to participate actively in the rehabilitation protocol, follow-up clinic and radiology protocol;
- Signature of informed consent.
Exclusion Criteria:
- Patients incapable of discernment;
- Patients with malignancy
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with metabolic disorders of the thyroid;
- Patients belonging abuse of alcohol, drugs or medications;
- Patients with misalignment of the lower limbs than 10 °;
- Body Mass Index> 40;
- Patients with a history of trauma or intra-articular infiltration of therapeutic substances within 6 months prior to treatment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110679
Italy | |
Rizzoli Orthopaedic Institute | Recruiting |
Bologna, Italy, 40136 | |
Contact: Elizaveta Kon, MD 0516366567 e.kon@biomec.ior.it | |
Contact: Giuseppe Filardo, MD 0516366501 |
Responsible Party: | Federica Balboni, Sub-Investigator, Istituto Ortopedico Rizzoli |
ClinicalTrials.gov Identifier: | NCT03110679 |
Other Study ID Numbers: |
OA-bi-Blind |
First Posted: | April 12, 2017 Key Record Dates |
Last Update Posted: | February 15, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
osteoarthritis autologous bone marrow concentrate |
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |