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

Launched by ISTITUTO ORTOPEDICO RIZZOLI · May 7, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatments for ankle osteoarthritis, which is a condition that causes pain and stiffness in the ankle due to the wear and tear of cartilage. The study specifically compares the effectiveness of BMAC (Bone Marrow Aspirate Concentrate) and HA (Hyaluronic Acid) injections over a period of 24 months. Patients will be assessed on various factors to see how well each treatment helps with their symptoms. If someone is in the control group receiving HA and feels they want to try BMAC after 12 months, they will have the option to switch.

To participate in this trial, individuals must be between the ages of 65 and 75 and have signs of ankle osteoarthritis affecting one ankle. They should not have had any recent surgeries or specific medical issues that could complicate the treatment. Throughout the study, participants can expect regular check-ins to monitor their progress and receive support in managing their condition. This trial is currently recruiting, and it aims to find better ways to treat ankle osteoarthritis and improve patients' quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with degenerative ankle cartilage disease;
• • 2. Unilateral involvement on the ankle;
• • 3. Signs and symptoms of degenerative pathology of the ankle cartilage;
• • 4. Radiographic or MRI signs of degenerative pathology of the ankle cartilage (OA Van Dijk grade 1-3);
• • 5. No clinically significant electrocardiographic changes (recently performed ECG).
• • 6. Ability and consent of patients to actively participate in clinical follow-up;
• Exclusion Criteria:
• • 1. Patients unable to give consent;
• • 2. Patients who have undergone intra-articular infiltration of another substance in the preceding 6 months;
• • 3. Patients who have undergone ankle surgery in the preceding 12 months;
• • 4. Patients with malignant neoplasms;
• • 5. Patients with rheumatic diseases;
• • 6. Patients with uncompensated diabetes;
• • 9. Patients with uncompensated thyroid metabolic disorders; 10. Patients who abuse alcoholic beverages, drugs or medications; 11. Body Mass Index \> 35;