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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous concentrated bone marrow aspirate | Experimental | autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of autologous concentrated bone marrow aspirate | Biological | Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizaveta Kon, MD | Rizzoli Orthopedic Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rizzoli Orthopaedic Institute | Bologna | 40136 | Italy |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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autologous concentrated bone marrow aspirate
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MRI score
| Time Frame: 6, 12, 24 months evaluation |
| D012216 |
| Rheumatic Diseases |