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

Istituto Ortopedico Rizzoli17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Injection of autologous concentrated bone marrow aspirateBIOLOGICAL

Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

Locations (1)

Rizzoli Orthopaedic Institute

Bologna, Italy

Outcomes

Primary Outcomes

improvement of the International Knee Documentation Committee (IKDC) subjective score

(International Knee Documentation Committee)

Time frame: Time Frame: 1,3,6, 12, 24 months evaluation

Secondary Outcomes

improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)

(Knee Injury and osteoarthritis Outcome Score)

Time frame: Time Frame: 1,3,6, 12, 24 months evaluation

evaluation of WORMS score for MRI

MRI score

Time frame: Time Frame: 6, 12, 24 months evaluation

Data from ClinicalTrials.gov

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