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

Istituto Ortopedico Rizzoli

Status

Active, not recruiting

Conditions

Cartilage Disease

Cartilage Damage

Treatments

Procedure: All Autologous Cartilage Regeneration

Study type

Interventional

Funder types

Other

Identifiers

NCT04785092

AACR

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Singular symptomatic chondral lesion classified as ICRS III or IV at the femoral condyle with less than 3 mm bone damage under the subchondral plate;
Lesion between 1 and 8 cm2;
BMI ≤ 34;
Ability and will to actively participate in a strict rehabilitation protocol and follow-up.

Exclusion criteria

Previous cartilage operation on the injured knee
Additional grade III or IV lesion on the same knee
Previous arthroscopic treatments that affect the AACR technique
Ligamentous/patellofemoral instability/malposition, varus or valgus malposition ≤3° which cannot be treated/corrected simultaneously
Previous tendon repair, ligament reconstruction or realignment within the last 6 months
Any known human immunodeficiency virus, hepatitis, syphilis, malignancy or uncontrolled diabetes
Uncooperative patients who disregard or cannot follow instructions, including those who abuse drugs and/or alcohol
Participation in a clinical drug or medical device trial that clinically interferes with the present observational study
Inability to follow procedures (i.e. dementia)
Inability to give consent
No understanding of German language
Pregnant or lactating women