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

• Sponsor: Istituto Ortopedico Rizzoli (Other)
• Overall Status: Completed
• CT.gov ID: NCT03110679
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 59.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Biological: injection of autologous bone marrow concentrate; Biological: injection of hyaluronic acid.	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: autologous bone marrow concentrate vs. hyaluronic acid.autologous bone marrow concentrate vs. hyaluronic acid.
• Masking: Double (Participant, Investigator)
• Masking Description: cover the syringe to mask the contents
• Primary Purpose: Treatment
• Official Title: Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid
• Actual Study Start Date: May 23, 2016
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: injection of autologous bone marrow concentrate
Experimental: hyaluronic acid. single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control.	Biological: injection of hyaluronic acid.

Outcome Measures

Primary Outcome Measures

1. International Knee Documentation Committee (IKDC)-Subjective score [Time Frame: 6 months]

   Clinical improvement, measured by the change in scores IKDC Subjective

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rizzoli Orthopaedic Institute	Bologna		Italy	40136

Sponsors and Collaborators

• Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT03110679
• Other Study ID Numbers: OA-bi-Blind
• First Posted: Apr 12, 2017
• Last Update Posted: Aug 4, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Istituto Ortopedico Rizzoli: osteoarthritis; autologous bone marrow concentrate
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Hyaluronic Acid

Study Results

No Results Posted as of Aug 4, 2021