Study for the Treatment of the Bone Marrow Edema:Core Decompression VS Bone Marrow Concentrate (BMC) VS Bone Substitute (BME-TARGET)

August 7, 2018 updated by: Federica Balboni, Istituto Ortopedico Rizzoli

Randomized, Double-blind Study for the Treatment of the Bone Marrow Edema:Core Decompression Versus (VS) Subchondral Injections of Autologous BMC VS Subchondral Injections of Bone Substitute

Randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of autologous BMC.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The clinical trial is a randomized, controlled, three-arm, double-blind study, involving up to 120 patients. Eligible subjects will be randomly allocated to one of the three treatment groups: control group, treated with core decompression technique, study group 1, treated with subchondral plasty by injecting i-FactorTM, and study group 2, treated by injections of autologous BMC.

Study Type

Interventional

Enrollment (Actual)

1

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female patients between 18 and 75 years;
  2. Symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the WORMS MRI score);
  3. Failure after at least two months of a conservative treatment;
  4. Single BME areas involving a single compartment of the knee;
  5. Availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology;
  6. Signature of informed consent.

Exclusion Criteria:

  1. Patients incapable of discernment;
  2. History of allergy to calcium phosphates;
  3. Patients with malignancies;
  4. Patients with rheumatic diseases;
  5. Patients with diabetes;
  6. Patients suffering of metabolic disorders of the thyroid;
  7. Patients with history of abuse of alcohol, drugs or medication;
  8. Patients with advanced osteoarthritis (Kellgren-Lawrence grade> 3);
  9. Body Mass Index> 35;
  10. BME that involve more than one compartment;
  11. Patients with trauma in the 6 months prior to the intervention. -

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: core decompression technique
The standard surgical technique is the subchondral anterograde drilling, which permit a revascularization of the Bone Marrow Edema (BME) and a reduction of the intramedullary pressure (core decompression).
Procedure: core decompression
subchondral anterograde drilling
Experimental: bone substitution (i-FactorTM)
i-FactorTM is a combination of the mineral component of bone (Anorganic Bone Mineral) with a peptide replicating the cell-binding domain of Type-I collagen (P-15). It has been used in bone defects and in spine fusion providing good clinical results. Thus, i-FactorTM could be a valid and efficient bone substitute to treat BMLs with subchondral injections.
Biological: bone substitute i-FactorTM
subchondral injections of i-FactorTM
Experimental: injections of autologous Bone Marrow Concentrate (BMC)
injections of autologous BMC.
Biological: autologous bone marrow concentrate
injection of autologous bone marrow concentrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of Visual Analogue Scale (VAS) score
Time Frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
improvement in VAS score from baseline to follow up
[Timepoint: Screening, 1 , 3 6, 12, 24 months]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC) subjective score
Time Frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
improvement in IKDC subjective score from baseline to follow up
[Timepoint: Screening, 1 , 3 6, 12, 24 months]
Knee Injury and Osteoarthritis Outcome (KOOS) Score
Time Frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
improvement in KOOS score from baseline to follow up
[Timepoint: Screening, 1 , 3 6, 12, 24 months]
Tegner Activity Level Scale
Time Frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
improvement in activity level scale from baseline to follow up
[Timepoint: Screening, 1 , 3 6, 12, 24 months]

Collaborators and Investigators

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

Sponsor

Istituto Ortopedico Rizzoli

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)

March 11, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BME-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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