CompletedNot Applicable

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

Italy20 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in knee functionality assessed by KOOS

Timeframe: (before treatment, 6, 12 and 24 months postoperative

Trial details

NCT IDNCT04785092

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-21