TerminatedNot Applicable

Evaluation of the Single Injection of BMAC vs HA in the Treatment of the Ankle Osteoarthritis

Stopped: Issues related to the adaptation of BMAC kits to the MDR

Italy18 participantsStarted 2021-12-15

Plain-language summary

The aim of the study is to compare the efficacy of the infiltrative therapy of BMAC vs HA up to 24 months in the treatment of the ankle osteoarthritis. The efficacy will be assessed through clinical, objective and subjective evaluations. After 12 months patients in the control group can decide to cross-over in the treatment group.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patients with degenerative ankle cartilage disease;
✓. Unilateral involvement on the ankle;
✓. Signs and symptoms of degenerative pathology of the ankle cartilage;
✓. Radiographic or MRI signs of degenerative pathology of the ankle cartilage (OA Van Dijk grade 1-3);
✓. No clinically significant electrocardiographic changes (recently performed ECG).
✓. Ability and consent of patients to actively participate in clinical follow-up;

Exclusion criteria

✕. Patients unable to give consent;
✕. Patients who have undergone intra-articular infiltration of another substance in the preceding 6 months;
✕. Patients who have undergone ankle surgery in the preceding 12 months;
✕. Patients with malignant neoplasms;
✕. Patients with rheumatic diseases;
✕. Patients with uncompensated diabetes;

What they're measuring

AOS (Ankle Osteoarthritis Scale)

Timeframe: Baseline, 1, 3, 6, 12, 24 months

Trial details

NCT IDNCT04883892

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-15

View on ClinicalTrials.gov More Ankle Osteoarthritis trials