TerminatedNo phase
Evaluation of the Single Injection of BMAC vs HA in the Treatment of the Ankle Osteoarthritis
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 18 people enrolled
- Started
- 15 Dec 2021
- Ended
- 11 Aug 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- BMAC
- HA
- Record updated
- 17 August 2025
- Why it stopped
- Issues related to the adaptation of BMAC kits to the MDR
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Patients unable to give consent
- Patients who have undergone intra-articular infiltration of another substance in the preceding 6 months
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- BMAC injectionTreatment being tested
Single injection of Bone Marrow Aspirate Concentrate (BMAC) into the ankle joint
Treatment: BMAC
- HA injectionsExisting treatment, for comparison
two injections of Hyaluronic Acid (HA) into the ankle joint - one injection every 15 days. After 12 months patients are allowed to cross-over in the BMAC arm.
Treatment: HA
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial
- Record updated
- 17 August 2025