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

NCT ID: NCT03112122

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-11
• Study Completion Date: 2017-12-31

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.

Conditions

Bone Marrow Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

core decompression

Intervention Type: PROCEDURE

subchondral anterograde drilling

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.

Group Type: EXPERIMENTAL

bone substitute i-FactorTM

Intervention Type: BIOLOGICAL

subchondral injections of i-FactorTM

injections of autologous Bone Marrow Concentrate (BMC)

injections of autologous BMC.

Group Type: EXPERIMENTAL

autologous bone marrow concentrate

Intervention Type: BIOLOGICAL

injection of autologous bone marrow concentrate

Interventions

autologous bone marrow concentrate

injection of autologous bone marrow concentrate

Intervention Type: BIOLOGICAL

bone substitute i-FactorTM

subchondral injections of i-FactorTM

Intervention Type: BIOLOGICAL

core decompression

subchondral anterograde drilling

Intervention Type: PROCEDURE

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Federica Balboni

Sub-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rizzoli Orthopaedic Institute

Bologna, , Italy

Countries

Italy

Other Identifiers

BME-TARGET

Identifier Type: -

Identifier Source: org_study_id