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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bone Marrow Edema

Intervention / Treatment
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* Biological: autologous bone marrow concentrate
* Biological: bone substitute i-FactorTM
* Procedure: core decompression


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, controlled, three-arm, double-blind study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: core decompression technique<br>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<br>* subchondral anterograde drilling<br>|
| Experimental: bone substitution (i-FactorTM)<br>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<br>* subchondral injections of i-FactorTM<br>|
| Experimental: injections of autologous Bone Marrow Concentrate (BMC)<br>injections of autologous BMC. | Biological: autologous bone marrow concentrate<br>* injection of autologous bone marrow concentrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Visual Analogue Scale (VAS) score | 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 | 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 | improvement in KOOS score from baseline to follow up | [Timepoint: Screening, 1 , 3 6, 12, 24 months] | 
| Tegner Activity Level Scale | improvement in activity level scale from baseline to follow up | [Timepoint: Screening, 1 , 3 6, 12, 24 months] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Marrow Edema, Mesenchymal Stem Cells