Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official 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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Biological: injection of autologous bone marrow concentrate
* Biological: injection of hyaluronic acid.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: autologous bone marrow concentrate vs. hyaluronic acid.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous bone marrow concentrate<br>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<br> <br> |
| Experimental: hyaluronic acid.<br>single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control. | Biological: injection of hyaluronic acid.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee (IKDC)-Subjective score | Clinical improvement, measured by the change in scores IKDC Subjective | Time Frame: 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee (IKDC)-Subjective score | Stability of the initial clinical improvement between 6 and 24 months | Time Frame: 1,3,6, 12, 24 months evaluation | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS). | Stability of the initial clinical improvement between 6 and 24 months of the KOOS pain score | Time Frame: 1,3,6, 12, 24 months evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, autologous bone marrow concentrate