Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-27 @ 4:58 AM
Study NCT ID:
NCT04883892
Status:
TERMINATED
Last Update Posted:
2025-08-17
First Post:
2021-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Single Injection of BMAC vs HA in the Treatment of the Ankle Osteoarthritis
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Study Overview
Official Title:
BMAC vs HA in Infiltrative Therapy for Osteoarthritis of the Ankle: Randomized Controlled Clinical Trial
Status:
TERMINATED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Issues related to the adaptation of BMAC kits to the MDR
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: