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

Istituto Ortopedico Rizzoli

Status and phase: Terminated; Phase 4

Conditions: Bone Marrow Edema

Treatments: Procedure: core decompression; Biological: autologous bone marrow concentrate; Biological: bone substitute i-FactorTM

Study type: Interventional

Funder types: Other

Identifiers

NCT03112122

BME-TARGET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

core decompression technique

Active Comparator group

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).

Treatment:

Procedure: core decompression

bone substitution (i-FactorTM)

Experimental group

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.

Treatment:

Biological: bone substitute i-FactorTM

injections of autologous Bone Marrow Concentrate (BMC)

Experimental group

Description:

injections of autologous BMC.

Treatment:

Biological: autologous bone marrow concentrate