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

NCT04785092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

  • Cartilage Damage
  • Cartilage Disease

Interventions

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.

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2025-01-21
Completion
2025-01-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04785092 on ClinicalTrials.gov