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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Injection of autologous concentrated bone marrow aspirate
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis ,, bone marrow aspirate, injections

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Rizzoli Orthopaedic Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous concentrated bone marrow aspirate

Arm Description

autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)
(Knee Injury and osteoarthritis Outcome Score)
evaluation of WORMS score for MRI
MRI score

Full Information

First Posted
March 30, 2017
Last Updated
May 27, 2022
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT03110666
Brief Title
Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study
Acronym
IOC-target
Official Title
Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
November 25, 2018 (Actual)
Study Completion Date
May 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis ,, bone marrow aspirate, injections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
autologous concentrated bone marrow aspirate
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous concentrated bone marrow aspirate
Arm Type
Experimental
Arm Description
autologous concentrated bone marrow aspirate obtained from the BioCUE Concentration System
Intervention Type
Biological
Intervention Name(s)
Injection of autologous concentrated bone marrow aspirate
Intervention Description
Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)
Primary Outcome Measure Information:
Title
improvement of the International Knee Documentation Committee (IKDC) subjective score
Description
(International Knee Documentation Committee)
Time Frame
Time Frame: 1,3,6, 12, 24 months evaluation
Secondary Outcome Measure Information:
Title
improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)
Description
(Knee Injury and osteoarthritis Outcome Score)
Time Frame
Time Frame: 1,3,6, 12, 24 months evaluation
Title
evaluation of WORMS score for MRI
Description
MRI score
Time Frame
Time Frame: 6, 12, 24 months evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizaveta Kon, MD
Organizational Affiliation
Rizzoli Orthopedic Institute
Official's Role
Study Director
Facility Information:
Facility Name
Rizzoli Orthopaedic Institute
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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