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

Phase 4

Terminated

• Conditions: Bone Marrow Edema

• Registration Number: NCT03112122
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2016-03-11
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-13
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome (KOOS) Score	[Timepoint: Screening, 1 , 3 6, 12, 24 months]	improvement in KOOS score from baseline to follow up
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

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy