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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial

Conditions
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Ankle Osteoarthritis

Intervention / Treatment
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* Procedure: BMAC
* Procedure: HA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: RCT, single-blind, allocation 1:1. After 12 months patients in the control group are allowed to cross-over in the treatment group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMAC injection<br>Single injection of Bone Marrow Aspirate Concentrate (BMAC) into the ankle joint | Procedure: BMAC<br>* 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<br>* Other names: Bone Marrow Aspirate Concentrate injection;|
| Active Comparator: HA injections<br>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. | Procedure: HA<br>* 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.<br>* Other names: Hyaluronic Acid injections;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 1, 3, 6, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1, 3, 6, 12, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone marrow aspirate concentrate, hyaluronic acid, BMAC, HA, ankle, ankle injection, ankle OA