Status:
TERMINATED
Evaluation of the Single Injection of BMAC vs HA in the Treatment of the Ankle Osteoarthritis
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Ankle Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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, ...
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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
- 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;
- 9\. Patients with uncompensated thyroid metabolic disorders; 10. Patients who abuse alcoholic beverages, drugs or medications; 11. Body Mass Index \> 35;
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04883892
Start Date
December 15 2021
End Date
August 11 2025
Last Update
August 17 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40124