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

Bone Marrow Edema Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03112122
• Other study ID #: BME-TARGET
• Status: Terminated
• Phase: Phase 4
• Start date: March 11, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2018
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Bone Marrow Edema
• Edema

Intervention

Biological:
• autologous bone marrow concentrate
injection of autologous bone marrow concentrate
• bone substitute i-FactorTM
subchondral injections of i-FactorTM

Procedure:
• core decompression
subchondral anterograde drilling

Locations

Country	Name	City	State
Italy	Rizzoli Orthopaedic Institute	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

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