NCT04785092

All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects

All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects: Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cartilage Damage
• Cartilage Disease

Interventions

Type	Name	Description
PROCEDURE	All Autologous Cartilage Regeneration	All patients will undergo firstly to a blood sampling and then to the arthroscopic debridement of the damage cartilage and subsequently will be harvested the surrounding healthy cartilage The harvested and healthy cartilage will shredded directly in situ with a shaver. This cartilage will then mixed with the patient's own Platelet Concentrate and may be injected directly into the cartilage defect. The Platelet Concentrate stimulates the healing of the cartilage most effectively. At the same time, the Platelet Concentrate will also used to produce autologous fibrin glue, which can be used to fix the applied cartilage chip / Platelet Concentrate product quickly and safely in the damaged cartilage.

Timeline

• Start date: 2021-03-01
• Primary completion: 2025-01-21
• Completion: 2025-01-21
• First posted: 2021-03-05
• Last updated: 2025-03-06

Locations

1 site across 1 country: Italy