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

NCT ID: NCT03110679

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-23
• Study Completion Date: 2021-05-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

injection of autologous bone marrow concentrate

Intervention Type: BIOLOGICAL

hyaluronic acid.

single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control.

Group Type: EXPERIMENTAL

injection of hyaluronic acid.

Intervention Type: BIOLOGICAL

Interventions

injection of autologous bone marrow concentrate

Intervention Type: BIOLOGICAL

injection of hyaluronic acid.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rizzoli Orthopaedic Institute

Bologna, , Italy

Countries

Italy

Other Identifiers

OA-bi-Blind

Identifier Type: -

Identifier Source: org_study_id