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

Istituto Ortopedico Rizzoli18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ankle Osteoarthritis

Interventions

BMACPROCEDURE

patients will be injected with BMAC into the ankle joint, after treatment patients will be followed up to 24 months. In particular patients will be assessed after treatment at 1, 3, 6, 12 and 24 months. During the injection, samples of BMAC will be collected for the characterization of the phenotype markers and clonogenic capability

HAPROCEDURE

patients will be treated with two injection of HA, one every 15 days, into the ankle joint. After treatment these patients will be followed up to 24 months. At 12 months patients can decide to cross.over in the BMAC arm treatment. After cross-over patients will be assessed for further 12 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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;

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

Outcomes

Primary Outcomes

AOS (Ankle Osteoarthritis Scale)

Evaluation of the change from baseline of the OAS score, assessing the trend of pain and function up to 24 months from the treatment

Time frame: Baseline, 1, 3, 6, 12, 24 months

Secondary Outcomes

AOFAS (The American Orthopedic Foot and Ankle Score)

Score 0-100 made by 3 categories: Pain (0-40), Function (0-50) and Alignment (0-10). The best clinical and function condition is represented by a score of 100. 0 is the worst possible condition.

Time frame: Baseline, 1, 3, 6, 12, 24 months

Data from ClinicalTrials.gov

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