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

Primary Purpose

Bone Marrow Edema

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
autologous bone marrow concentrate
bone substitute i-FactorTM
core decompression
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Marrow Edema focused on measuring Bone Marrow Edema, Mesenchymal Stem Cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. -

Sites / Locations

  • Rizzoli Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

core decompression technique

bone substitution (i-FactorTM)

injections of autologous Bone Marrow Concentrate (BMC)

Arm Description

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).

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.

injections of autologous BMC.

Outcomes

Primary Outcome Measures

change of Visual Analogue Scale (VAS) score
improvement in VAS score from baseline to follow up

Secondary Outcome Measures

International Knee Documentation Committee (IKDC) subjective score
improvement in IKDC subjective score from baseline to follow up
Knee Injury and Osteoarthritis Outcome (KOOS) Score
improvement in KOOS score from baseline to follow up
Tegner Activity Level Scale
improvement in activity level scale from baseline to follow up

Full Information

First Posted
March 30, 2017
Last Updated
August 7, 2018
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT03112122
Brief Title
Study for the Treatment of the Bone Marrow Edema:Core Decompression VS Bone Marrow Concentrate (BMC) VS Bone Substitute
Acronym
BME-TARGET
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
difficulty in recruiting
Study Start Date
March 11, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Edema
Keywords
Bone Marrow Edema, Mesenchymal Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized, controlled, three-arm, double-blind study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
core decompression technique
Arm Type
Active Comparator
Arm Description
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).
Arm Title
bone substitution (i-FactorTM)
Arm Type
Experimental
Arm Description
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.
Arm Title
injections of autologous Bone Marrow Concentrate (BMC)
Arm Type
Experimental
Arm Description
injections of autologous BMC.
Intervention Type
Biological
Intervention Name(s)
autologous bone marrow concentrate
Intervention Description
injection of autologous bone marrow concentrate
Intervention Type
Biological
Intervention Name(s)
bone substitute i-FactorTM
Intervention Description
subchondral injections of i-FactorTM
Intervention Type
Procedure
Intervention Name(s)
core decompression
Intervention Description
subchondral anterograde drilling
Primary Outcome Measure Information:
Title
change of Visual Analogue Scale (VAS) score
Description
improvement in VAS score from baseline to follow up
Time Frame
[Timepoint: Screening, 1 , 3 6, 12, 24 months]
Secondary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC) subjective score
Description
improvement in IKDC subjective score from baseline to follow up
Time Frame
[Timepoint: Screening, 1 , 3 6, 12, 24 months]
Title
Knee Injury and Osteoarthritis Outcome (KOOS) Score
Description
improvement in KOOS score from baseline to follow up
Time Frame
[Timepoint: Screening, 1 , 3 6, 12, 24 months]
Title
Tegner Activity Level Scale
Description
improvement in activity level scale from baseline to follow up
Time Frame
[Timepoint: Screening, 1 , 3 6, 12, 24 months]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female patients between 18 and 75 years; Symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the WORMS MRI score); Failure after at least two months of a conservative treatment; Single BME areas involving a single compartment of the knee; Availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology; Signature of informed consent. Exclusion Criteria: Patients incapable of discernment; History of allergy to calcium phosphates; Patients with malignancies; Patients with rheumatic diseases; Patients with diabetes; Patients suffering of metabolic disorders of the thyroid; Patients with history of abuse of alcohol, drugs or medication; Patients with advanced osteoarthritis (Kellgren-Lawrence grade> 3); Body Mass Index> 35; BME that involve more than one compartment; Patients with trauma in the 6 months prior to the intervention. -
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

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

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