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

NCT03110679 | Completed Phase 4

• 1 other identifier: OA-bi-Blind
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; autologous bone marrow concentrate

Outcome Measures

Primary Outcomes (1)

• International Knee Documentation Committee (IKDC)-Subjective score

  Clinical improvement, measured by the change in scores IKDC Subjective

  Time Frame: 6 months

Secondary Outcomes (2)

• International Knee Documentation Committee (IKDC)-Subjective score

  Time Frame: 1,3,6, 12, 24 months evaluation

• Knee Injury and Osteoarthritis Outcome Score (KOOS).

  Time Frame: 1,3,6, 12, 24 months evaluation

Study Arms (2)

autologous bone marrow concentrate

EXPERIMENTAL

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

hyaluronic acid.

EXPERIMENTAL

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

Biological: injection of hyaluronic acid.

Interventions

injection of autologous bone marrow concentrate BIOLOGICAL

autologous bone marrow concentrate

injection of hyaluronic acid. BIOLOGICAL

hyaluronic acid.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: cover the syringe to mask the contents
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: autologous bone marrow concentrate vs. hyaluronic acid.

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 12, 2017
• Study Start: May 23, 2016
• Primary Completion: November 1, 2016
• Study Completion: May 1, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)