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

  • STATUS
    Recruiting
  • End date
    Jul 27, 2027
  • participants needed
    120
  • sponsor
    Istituto Ortopedico Rizzoli
Updated on 27 August 2021

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.

Description

All the patients who meet the inclusion criteria and giving written informed consent will be randomized. We planned to enrol 120 patients.

Following the randomization, every patient will be treated with a single injection of Bone Marrow Aspirate Concentrate (BMAC) or two injections of Hyaluronic Acid (HA) in the affected ankle.

After the treatment patients will be followed up to 24 months whit clinical and radiological assessment.

After 12 months patients in the control group can decide to cross-over in the treatment group with BMAC. These patients will be followed up further 12 months.

Details
Condition Ankle Osteoarthritis
Treatment HA, BMAC
Clinical Study IdentifierNCT04883892
SponsorIstituto Ortopedico Rizzoli
Last Modified on27 August 2021

Eligibility

Yes No Not Sure

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
Patients with uncompensated thyroid metabolic disorders; 10. Patients who abuse alcoholic beverages, drugs or medications; 11. Body Mass Index > 35
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