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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Biological: Injection of autologous concentrated bone marrow aspirate


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: autologous concentrated bone marrow aspirate
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous concentrated bone marrow aspirate<br>autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System | Biological: Injection of autologous concentrated bone marrow aspirate<br>* Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of the International Knee Documentation Committee (IKDC) subjective score | (International Knee Documentation Committee) | Time Frame: 1,3,6, 12, 24 months evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS) | (Knee Injury and osteoarthritis Outcome Score) | Time Frame: 1,3,6, 12, 24 months evaluation | 
| evaluation of WORMS score for MRI | MRI score | Time Frame: 6, 12, 24 months evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis ,, bone marrow aspirate, injections