Ankle Osteoarthritis
Conditions
Keywords
bone marrow aspirate concentrate, hyaluronic acid, BMAC, HA, ankle, ankle injection, ankle OA
Brief summary
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
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.
Interventions
PROCEDUREBMAC
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
PROCEDUREHA
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.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AOS (Ankle Osteoarthritis Scale) | Baseline, 1, 3, 6, 12, 24 months | Evaluation of the change from baseline of the OAS score, assessing the trend of pain and function up to 24 months from the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AOFAS (The American Orthopedic Foot and Ankle Score) | Baseline, 1, 3, 6, 12, 24 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| EuroQol Visual Analogue Scale (EQ-VAS) | Baseline, 1, 3, 6, 12, 24 months | 0 - 100 scale where 100 is the best possible healthand 0 is the worst possible health |
| EQ-5D (EuroQoL) Current Health Assessment | Baseline, 1, 3, 6, 12, 24 months | Score for the assessment of the quality of life of the patient. |
| VAS function (Visual Analog Score - function) | Baseline, 1, 3, 6, 12, 24 months | the scale is to expect the patient to select the number that best describes their functional disability status, in a range of length from 0 to 10 cm. The higher the value indicated the higher the degree of disability. |
| Evaluation of the osteoarthrosis progression of the ankle joint after treatment through radiological exams | 12, 24 months | RX and MRI will be performed at 12 and 24 month after treatment |
| Patient Acceptable Symptom State (PASS) | Baseline, 1, 3, 6, 12, 24 months | tool for assessing patient satisfaction in consideration of their current degree of pain, function and daily activity. The patient will evaluate his degree of satisfaction by answering a dichotomous closed question (yes / no). |
| VAS pain (Visual Analog Score - pain) | Baseline, 1, 3, 6, 12, 24 months | the scale is to expect the patient to select the number that best describes their pain status, in a range of length from 0 to 10 cm. The higher the value indicated the higher the degree of disability. |
Countries
Italy
Outcome results
None listed