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

NCT ID: NCT03110666

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-14
• Study Completion Date: 2022-05-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous concentrated bone marrow aspirate

autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System

Group Type: EXPERIMENTAL

Injection of autologous concentrated bone marrow aspirate

Intervention Type: BIOLOGICAL

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

Interventions

Injection of autologous concentrated bone marrow aspirate

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizaveta Kon, MD

Role: STUDY_DIRECTOR

Rizzoli Orthopedic Institute

Locations

Rizzoli Orthopaedic Institute

Bologna, , Italy

Countries

Italy

Other Identifiers

IOC-target

Identifier Type: -

Identifier Source: org_study_id