CompletedPhase 4

Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid

Italy60 participantsStarted 2016-05-23

Plain-language summary

OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Male or female patients, aged between 18 and 75 years;
✓. Bilateral symptomatic knee osteoarthritis (Kellgren-Lawrence grade 1-4);
✓. Failure after two months of conservative treatment;
✓. Capacity and consent of patients to participate actively in the rehabilitation protocol, follow-up clinic and radiology protocol;
✓. Signature of informed consent.

Exclusion criteria

✕. Patients incapable of discernment;
✕. Patients with malignancy
✕. Patients with rheumatic diseases;
✕. Patients with diabetes;
✕. Patients with metabolic disorders of the thyroid;
✕. Patients belonging abuse of alcohol, drugs or medications;
✕. Patients with misalignment of the lower limbs than 10 °;
✕. Body Mass Index\> 40;

What they're measuring

International Knee Documentation Committee (IKDC)-Subjective score

Timeframe: Time Frame: 6 months

Trial details

NCT IDNCT03110679

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11

View on ClinicalTrials.gov More Osteoarthritis, Knee trials