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

May 27, 2022 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Rizzoli Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Autologous concentrated bone marrow aspirate
autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System
Biological: Injection of autologous concentrated bone marrow aspirate
Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Study Director: Elizaveta Kon, MD, Rizzoli Orthopedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 14, 2016

Primary Completion (ACTUAL)

November 25, 2018

Study Completion (ACTUAL)

May 1, 2022

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (ACTUAL)

April 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOC-target

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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