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

Phase 4

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT03110666
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2016-11-14
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Primary Completion: 2018-11-25
• Status Verified: 2022-05
• Study Completion: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
improvement of the International Knee Documentation Committee (IKDC) subjective score	Time Frame: 1,3,6, 12, 24 months evaluation	(International Knee Documentation Committee)

Secondary Outcome Measures

Name	Time	Method
evaluation of WORMS score for MRI	Time Frame: 6, 12, 24 months evaluation	MRI score
improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)	Time Frame: 1,3,6, 12, 24 months evaluation	(Knee Injury and osteoarthritis Outcome Score)

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy