Comparing BMAC and HA injections for ankle osteoarthritis treatment
BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial
This study is testing whether a single injection of bone marrow concentrate works better than two injections of hyaluronic acid for treating ankle osteoarthritis over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT04883892 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a single injection of Bone Marrow Aspirate Concentrate (BMAC) compared to two injections of Hyaluronic Acid (HA) in treating ankle osteoarthritis over a period of 24 months. Patients who meet the inclusion criteria will be randomized to receive either treatment, and their progress will be monitored through clinical and radiological assessments. After 12 months, patients in the HA group will have the option to switch to BMAC treatment. The study plans to enroll 120 participants to gather comprehensive data on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals with unilateral degenerative ankle cartilage disease and specific radiographic signs of osteoarthritis.
Not a fit: Patients with recent ankle surgery, significant comorbidities, or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from ankle osteoarthritis.
How similar studies have performed: Previous studies have shown promising results with similar approaches using BMAC for joint conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Vannini, MD
- Email: francesca.vannini@ior.it
- Phone: 051-6366878
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.