Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- improvement of the International Knee Documentation Committee (IKDC) subjective score
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
Autologous concentrated bone marrow aspirate
autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System
Intervention: Injection of autologous concentrated bone marrow aspirate (Biological)
Outcomes
Primary Outcomes
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 Outcomes
- evaluation of WORMS score for MRI(Time Frame: 6, 12, 24 months evaluation)
- improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)(Time Frame: 1,3,6, 12, 24 months evaluation)