NCT03110666

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Injection of autologous concentrated bone marrow aspirate	Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)

Timeline

• Start date: 2016-11-14
• Primary completion: 2018-11-25
• Completion: 2022-05-01
• First posted: 2017-04-12
• Last updated: 2022-05-31

Locations

1 site across 1 country: Italy