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

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Biological: injection of hyaluronic acid.; Biological: injection of autologous bone marrow concentrate

• Registration Number: NCT03110679
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2016-05-23
• Primary Completion: 2016-11
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Status Verified: 2021-02
• Study Completion: 2021-05
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyaluronic acid.	injection of hyaluronic acid.	single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control.
autologous bone marrow concentrate	injection of 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy