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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03112122

Acronym

BME-TARGET

Enrollment

Registered

2017-04-13

Start date

2016-03-11

Completion date

2017-12-31

Last updated

2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Edema

Keywords

Bone Marrow Edema, Mesenchymal Stem Cells

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.

Interventions

BIOLOGICALautologous bone marrow concentrate

injection of autologous bone marrow concentrate

BIOLOGICALbone substitute i-FactorTM

subchondral injections of i-FactorTM

PROCEDUREcore decompression

subchondral anterograde drilling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

randomized, controlled, three-arm, double-blind study

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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. -

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026