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

Knee Osteoarthritis Clinical Trial

— IOC-target  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110666
• Other study ID #: IOC-target
• Status: Completed
• Phase: Phase 4
• Start date: November 14, 2016
• Est. completion date: May 2022

Study information

• Verified date: May 2022
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2022
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Injection of autologous concentrated bone marrow aspirate
Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)

Locations

Country	Name	City	State
Italy	Rizzoli Orthopaedic Institute	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of the International Knee Documentation Committee (IKDC) subjective score	(International Knee Documentation Committee)	Time Frame: 1,3,6, 12, 24 months evaluation
Secondary	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
Secondary	evaluation of WORMS score for MRI	MRI score	Time Frame: 6, 12, 24 months evaluation