TerminatedPhase 4

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

Stopped: difficulty in recruiting

Italy1 participantsStarted 2016-03-11

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patients between 18 and 75 years;
✓. Symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the WORMS MRI score);
✓. Failure after at least two months of a conservative treatment;
✓. Single BME areas involving a single compartment of the knee;
✓. Availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology;
✓. Signature of informed consent.

Exclusion criteria

✕. Patients incapable of discernment;
✕. History of allergy to calcium phosphates;
✕. Patients with malignancies;
✕. Patients with rheumatic diseases;
✕. Patients with diabetes;
✕. Patients suffering of metabolic disorders of the thyroid;
✕. Patients with history of abuse of alcohol, drugs or medication;
✕. Patients with advanced osteoarthritis (Kellgren-Lawrence grade\> 3);

What they're measuring

change of Visual Analogue Scale (VAS) score

Timeframe: [Timepoint: Screening, 1 , 3 6, 12, 24 months]

Trial details

NCT IDNCT03112122

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-31

View on ClinicalTrials.gov More Bone Marrow Edema trials