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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Biological: injection of autologous bone marrow concentrate; Biological: injection of 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Rizzoli Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis; autologous bone marrow concentrate
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: OA-bi-Blind

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No