Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid (OA-bi-Blind)
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
injection of autologous bone marrow concentrate
injection of hyaluronic acid.
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, autologous bone marrow concentrate
Eligibility Criteria
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.
Sites / Locations
- Rizzoli Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
autologous bone marrow concentrate
hyaluronic acid.
Arm Description
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.
single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control.
Outcomes
Primary Outcome Measures
International Knee Documentation Committee (IKDC)-Subjective score
Clinical improvement, measured by the change in scores IKDC Subjective
Secondary Outcome Measures
International Knee Documentation Committee (IKDC)-Subjective score
Stability of the initial clinical improvement between 6 and 24 months
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Stability of the initial clinical improvement between 6 and 24 months of the KOOS pain score
Full Information
NCT ID
NCT03110679
First Posted
March 30, 2017
Last Updated
August 3, 2021
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT03110679
Brief Title
Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
Acronym
OA-bi-Blind
Official Title
Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
May 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
osteoarthritis, autologous bone marrow concentrate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
autologous bone marrow concentrate vs. hyaluronic acid.
Masking
ParticipantInvestigator
Masking Description
cover the syringe to mask the contents
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
autologous bone marrow concentrate
Arm Type
Experimental
Arm Description
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.
Arm Title
hyaluronic acid.
Arm Type
Experimental
Arm Description
single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control.
Intervention Type
Biological
Intervention Name(s)
injection of autologous bone marrow concentrate
Intervention Type
Biological
Intervention Name(s)
injection of hyaluronic acid.
Primary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC)-Subjective score
Description
Clinical improvement, measured by the change in scores IKDC Subjective
Time Frame
Time Frame: 6 months
Secondary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC)-Subjective score
Description
Stability of the initial clinical improvement between 6 and 24 months
Time Frame
Time Frame: 1,3,6, 12, 24 months evaluation
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Description
Stability of the initial clinical improvement between 6 and 24 months of the KOOS pain score
Time Frame
Time Frame: 1,3,6, 12, 24 months evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Rizzoli Orthopaedic Institute
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
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