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

Istituto Ortopedico Rizzoli

Status: Terminated

Conditions: Ankle Osteoarthritis

Treatments: Procedure: HA; Procedure: BMAC

Study type: Interventional

Funder types: Other

Identifiers

NCT04883892

BMAC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

BMAC injection

Experimental group

Description:

Single injection of Bone Marrow Aspirate Concentrate (BMAC) into the ankle joint

Treatment:

Procedure: BMAC

HA injections

Active Comparator group

Description:

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:

Procedure: HA