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

Phase 4

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Biological: Injection of autologous concentrated bone marrow aspirate

• 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

Arm && Interventions

Group	Intervention	Description
Autologous concentrated bone marrow aspirate	Injection of autologous concentrated bone marrow aspirate	autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System

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