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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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ClinicalTrials.gov Identifier: NCT03110679
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Federica Balboni, Istituto Ortopedico Rizzoli

Study Description
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Brief Summary:
OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: injection of autologous bone marrow concentrate Biological: injection of hyaluronic acid. Phase 4

Detailed Description:
a randomized, controlled, double-blind study and we will be evaluated and compared the clinical and radiological results of concentrated autologous bone marrow against the hyaluronic acid in patients with bilateral knee osteoarthrosis . In randomization, one knee will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid, then every patient is considered both in control and treatment group, limiting the heterogenity between groups and will not be informed of the knee assigned to the treatment group.

Study Design
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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 : August 2019
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 Biological: injection of hyaluronic acid.


Outcome Measures
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Primary Outcome Measures :
  1. International Knee Documentation Committee (IKDC)-Subjective score [ Time Frame: Time Frame: 6 months ]
    Clinical improvement, measured by the change in scores IKDC Subjective


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Italy
Rizzoli Orthopaedic Institute Recruiting
Bologna, Italy, 40136
Contact: Elizaveta Kon, MD    0516366567    e.kon@biomec.ior.it   
Contact: Giuseppe Filardo, MD    0516366501      
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
More Information
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Responsible Party: Federica Balboni, Sub-Investigator, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03110679     History of Changes
Other Study ID Numbers: OA-bi-Blind
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Federica Balboni, Istituto Ortopedico Rizzoli:
osteoarthritis
autologous bone marrow concentrate

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents