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

NCT03110666 | Completed Phase 4

• 1 other identifier: IOC-target
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis ,; bone marrow aspirate; injections

Outcome Measures

Primary Outcomes (1)

• improvement of the International Knee Documentation Committee (IKDC) subjective score

  (International Knee Documentation Committee)

  Time Frame: 1,3,6, 12, 24 months evaluation

Secondary Outcomes (2)

• improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)

  Time Frame: 1,3,6, 12, 24 months evaluation

• evaluation of WORMS score for MRI

  Time Frame: 6, 12, 24 months evaluation

Study Arms (1)

Autologous concentrated bone marrow aspirate

EXPERIMENTAL

autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System

Biological: Injection of autologous concentrated bone marrow aspirate

Interventions

Injection of autologous concentrated bone marrow aspirate BIOLOGICAL

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

Autologous concentrated bone marrow aspirate

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Elizaveta Kon, MD

  Rizzoli Orthopedic Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: autologous concentrated bone marrow aspirate

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 12, 2017
• Study Start: November 14, 2016
• Primary Completion: November 25, 2018
• Study Completion: May 1, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)