NCT04883892

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankle Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	BMAC	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
PROCEDURE	HA	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.

Timeline

• Start date: 2021-12-15
• Primary completion: 2022-06-15
• Completion: 2025-08-11
• First posted: 2021-05-12
• Last updated: 2025-08-17

Locations

1 site across 1 country: Italy