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

Osteoarthritis, Knee Clinical Trial

— OA-bi-Blind  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110679
• Other study ID #: OA-bi-Blind
• Status: Completed
• Phase: Phase 4
• Start date: May 23, 2016
• Est. completion date: May 2021

Study information

• Verified date: February 2021
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2021
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• injection of autologous bone marrow concentrate

• injection of hyaluronic acid.

Locations

Country	Name	City	State
Italy	Rizzoli Orthopaedic Institute	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

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