Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-03 @ 10:23 PM
Study NCT ID:
NCT04785092
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2021-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Study Overview
Official Title:
All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects: Pilot Study
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The cartilage articular defects of the knee are extremely disabling lesions and represent one of the predisposition causes to the development of articular arthrosis.
When clinical symptoms are present, exist the indication to treat the patient surgically, to this end, several surgical techniques could be performed, as the microfractures, osteochondral transplantation (OCT) or chondrocytes autologous transplantation (ACT).
The aim of this pilot study is to evaluate the clinical performance of a modified version of the ACT technique, the All Autologous Cartilage Repair technique (AACR). A one-step technique in which the healthy cartilage harvested is fragmented directly in situ and then mixed with the autologous platelet concentrate and directly injected in the cartilage defect.. This lead to a less invasive surgery and cost-effective procedure.
The performance will be evaluated through the evaluation of clinical results and complications after surgery other than the evaluation of the quality of the cartilage tissue repaired.
When clinical symptoms are present, exist the indication to treat the patient surgically, to this end, several surgical techniques could be performed, as the microfractures, osteochondral transplantation (OCT) or chondrocytes autologous transplantation (ACT).
The aim of this pilot study is to evaluate the clinical performance of a modified version of the ACT technique, the All Autologous Cartilage Repair technique (AACR). A one-step technique in which the healthy cartilage harvested is fragmented directly in situ and then mixed with the autologous platelet concentrate and directly injected in the cartilage defect.. This lead to a less invasive surgery and cost-effective procedure.
The performance will be evaluated through the evaluation of clinical results and complications after surgery other than the evaluation of the quality of the cartilage tissue repaired.
Detailed Description:
The aim of the Pilot Study is to describe the clinical performance of the AACR technique in the treatment of the cartilage defects in terms of complications after surgery, quality of the repaired cartilage tissue and clinical results with regard to pain and function of the treated knee.
The quality of the repaired cartilage tissue will be evaluate through MRI and clinical outcomes by the Patient Reported Outcome Measures (PROMs).
All patients will undergo to a blood sample (used to product the patient's own platelet concentrate) and an arthroscopic procedure to debride degenerated cartilage tissue and to the harvesting of the surrounding healthy cartilage. The fragmented healthy cartilage will mixed with the platelet concentrate (PC) and injected directly into the cartilage defect to fill it. The platelet concentrate stimulates the healing of the cartilage most actively.
Before and after surgical treatment all patient will undergo to a follow-up visits after 6, 12 and 24 months. MRI will be performed at pre-surgery visit and at the 12 and 24 follow-up visits.
The quality of the repaired cartilage tissue will be evaluate through MRI and clinical outcomes by the Patient Reported Outcome Measures (PROMs).
All patients will undergo to a blood sample (used to product the patient's own platelet concentrate) and an arthroscopic procedure to debride degenerated cartilage tissue and to the harvesting of the surrounding healthy cartilage. The fragmented healthy cartilage will mixed with the platelet concentrate (PC) and injected directly into the cartilage defect to fill it. The platelet concentrate stimulates the healing of the cartilage most actively.
Before and after surgical treatment all patient will undergo to a follow-up visits after 6, 12 and 24 months. MRI will be performed at pre-surgery visit and at the 12 and 24 follow-up visits.
Study Oversight
Has Oversight DMC:
False
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?: