Ankle Osteoarthritis Clinical Trial
Official title:
BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial
NCT number | NCT04883892 |
Other study ID # | BMAC |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 15, 2021 |
Est. completion date | July 2027 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | July 2027 |
Est. primary completion date | June 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Rizzoli | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Italy,
Buda R, Vannini F, Castagnini F, Cavallo M, Ruffilli A, Ramponi L, Pagliazzi G, Giannini S. Regenerative treatment in osteochondral lesions of the talus: autologous chondrocyte implantation versus one-step bone marrow derived cells transplantation. Int Orthop. 2015 May;39(5):893-900. doi: 10.1007/s00264-015-2685-y. Epub 2015 Feb 8. — View Citation
Giannini S, Buda R, Cavallo M, Ruffilli A, Cenacchi A, Cavallo C, Vannini F. Cartilage repair evolution in post-traumatic osteochondral lesions of the talus: from open field autologous chondrocyte to bone-marrow-derived cells transplantation. Injury. 2010 Nov;41(11):1196-203. doi: 10.1016/j.injury.2010.09.028. Epub 2010 Oct 8. — View Citation
Kennedy JG, Murawski CD. The Treatment of Osteochondral Lesions of the Talus with Autologous Osteochondral Transplantation and Bone Marrow Aspirate Concentrate: Surgical Technique. Cartilage. 2011 Oct;2(4):327-36. doi: 10.1177/1947603511400726. — View Citation
Luciani D, Cadossi M, Tesei F, Chiarello E, Giannini S. Viscosupplementation for grade II osteoarthritis of the ankle: a prospective study at 18 months' follow-up. Chir Organi Mov. 2008 Dec;92(3):155-60. doi: 10.1007/s12306-008-0066-z. Epub 2008 Dec 6. — View Citation
Shapiro SA, Kazmerchak SE, Heckman MG, Zubair AC, O'Connor MI. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med. 2017 Jan;45(1):82-90. doi: 10.1177/0363546516662455. Epub 2016 Sep 30. — View Citation
Vannini F, Cavallo M, Ramponi L, Castagnini F, Massimi S, Giannini S, Buda RE. Return to Sports After Bone Marrow-Derived Cell Transplantation for Osteochondral Lesions of the Talus. Cartilage. 2017 Jan;8(1):80-87. doi: 10.1177/1947603516642574. Epub 2016 Apr 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | VAS function (Visual Analog Score - function) | 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. | Baseline, 1, 3, 6, 12, 24 months | |
Other | VAS pain (Visual Analog Score - pain) | 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. | Baseline, 1, 3, 6, 12, 24 months | |
Other | EuroQol Visual Analogue Scale (EQ-VAS) | 0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health" | Baseline, 1, 3, 6, 12, 24 months | |
Other | EQ-5D (EuroQoL) Current Health Assessment | Score for the assessment of the quality of life of the patient. | Baseline, 1, 3, 6, 12, 24 months | |
Other | Patient Acceptable Symptom State (PASS) | 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). | Baseline, 1, 3, 6, 12, 24 months | |
Other | Evaluation of the osteoarthrosis progression of the ankle joint after treatment through radiological exams | RX and MRI will be performed at 12 and 24 month after treatment | 12, 24 months | |
Primary | 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 | 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 |
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