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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03110679

Acronym

OA-bi-Blind

Enrollment

Registered

2017-04-12

Start date

2016-05-23

Completion date

2021-05-31

Last updated

2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis, autologous bone marrow concentrate

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.

Interventions

BIOLOGICALinjection of autologous bone marrow concentrate

BIOLOGICALinjection of hyaluronic acid.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

cover the syringe to mask the contents

Intervention model description

autologous bone marrow concentrate vs. hyaluronic acid.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026