Clinical trial NCT04883892: Evaluation of the Single Injection of BMAC vs HA in the Treatment of the Ankle Osteoarthritis
Official title: BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankle Osteoarthritis
Keywords: bone marrow aspirate concentrate
hyaluronic acid
BMAC
HA
ankle
ankle injection
ankle OA
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: AOS (Ankle Osteoarthritis Scale)
timeFrame: Baseline, 1, 3, 6, 12, 24 months
Secondary outcomes:
measure: AOFAS (The American Orthopedic Foot and Ankle Score)
timeFrame: Baseline, 1, 3, 6, 12, 24 months
Other outcomes:
measure: VAS function (Visual Analog Score - function)
timeFrame: Baseline, 1, 3, 6, 12, 24 months
measure: VAS pain (Visual Analog Score - pain)
timeFrame: Baseline, 1, 3, 6, 12, 24 months
measure: EuroQol Visual Analogue Scale (EQ-VAS)
timeFrame: Baseline, 1, 3, 6, 12, 24 months
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: Baseline, 1, 3, 6, 12, 24 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Baseline, 1, 3, 6, 12, 24 months
measure: Evaluation of the osteoarthrosis progression of the ankle joint after treatment through radiological exams
timeFrame: 12, 24 months
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
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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.
citation: 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.
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.
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.