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Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study (IOC-target)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03110666
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Federica Balboni, Istituto Ortopedico Rizzoli

Brief Summary:
This pilot study will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of autologous concentrated bone marrow aspirate at the bone-cartilage interface via percutaneous.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Injection of autologous concentrated bone marrow aspirate Phase 4

Detailed Description:
This pilot study (N=30) patients will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of bone marrow concentrate (BMC),obtained from the Bone Marrow Aspirate Concentration System (BioCUE) at the bone-cartilage interface via percutaneous injections. The PerFuse system will also be evaluated to determine if it can be used to deliver the BMC to the osseous sites. Follow-up is 1, 3, 6, 12, and 24 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Intervention Model Description: autologous concentrated bone marrow aspirate
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study
Actual Study Start Date : July 25, 2016
Actual Primary Completion Date : June 25, 2019
Estimated Study Completion Date : July 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Autologous concentrated bone marrow aspirate
autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System
Biological: Injection of autologous concentrated bone marrow aspirate
Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)




Primary Outcome Measures :
  1. improvement of the International Knee Documentation Committee (IKDC) subjective score [ Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation ]
    (International Knee Documentation Committee)


Secondary Outcome Measures :
  1. improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS) [ Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation ]
    (Knee Injury and osteoarthritis Outcome Score)

  2. evaluation of WORMS score for MRI [ Time Frame: Time Frame: 6, 12, 24 months evaluation ]
    MRI score



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ranging from 40 to 75
  • Osteoarthritis of the medial or lateral compartment (2-3-4 grade according to the Kellgren-Lawrence score);
  • Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs,hyaluronic acid,platelet-rich plasma and corticosteroids injections);
  • Signature of informed consent.

Exclusion Criteria:

  • Patients with trauma in the 6 months prior to the intervention;
  • Patients with malignancies;
  • Patients with rheumatic diseases;
  • Patients with diabetes;
  • Patients suffering from metabolic disorders of the thyroid;
  • Patients being abuse of alcohol, drugs or medications;
  • Body Mass Index> 35;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110666


Locations
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Italy
Rizzoli Orthopaedic Institute
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Study Director: Elizaveta Kon, MD Rizzoli Orthopedic Institute

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Responsible Party: Federica Balboni, Sub-Investigator, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03110666     History of Changes
Other Study ID Numbers: IOC-target
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federica Balboni, Istituto Ortopedico Rizzoli:
knee osteoarthritis ,
bone marrow aspirate
injections
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases