Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Summary

Conditions
Knee Osteoarthritis
Type
Interventional
Phase
Phase 4
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: autologous concentrated bone marrow aspirateMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 75 years
Gender
Both males and females

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 injection...

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.

Tracking Information

NCT #
NCT03110666
Collaborators
Not Provided
Investigators
Study Director: Elizaveta Kon, MD Rizzoli Orthopedic Institute