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

Ankle Osteoarthritis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04883892
Study type Interventional
Source Istituto Ortopedico Rizzoli
Contact Francesca Vannini, MD
Phone 051-6366878
Email francesca.vannini@ior.it
Status Recruiting
Phase N/A
Start date December 15, 2021
Completion date July 2027
View Details
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