AutoCart Study

  • Research type

    Research Study

  • Full title

    AutoCart – All Autologous Cartilage Regeneration for the Treatment of Cartilage Defects in the Knee: A Prospective Case Series

  • IRAS ID

    294769

  • Contact name

    Bilal M Barkatali

  • Contact email

    Bilal.Barkatali2@nca.nhs.uk

  • Sponsor organisation

    Northern Care Alliance NHS Foundation Trust

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    The AutoCart study is designed to collect objective and subjective data on the outcomes and efficacy of the AutoCart cartilage repair technique. This is a technique which allows the cartilage defect in the knee to be repaired in a single operation using autologous chondral cells and biological techniques. This technique is already available and has been performed at Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust (NCAFT).

    Lay Summary of Results

    The aim of the study was to assess the outcomes and complications a novel cartilage regeneration procedure in the knee. Primary outcome was the validated KOOS score and secondary outcome assessment of cartilage quality via MRI scanning.

    Background

    Articular cartilage damage of the knee joint in patients younger than 55 is a predisposition for the development of arthrosis1. If clinical symptoms are present, there is a clear consensus within professional associations2 that the patient must be treated surgically, in order to preserve the joint and enable a return to a pain-free activity3. For this purpose, various surgical techniques can be applied such as microfracturing, osteochondral transplantation (OCT) or autologous cartilage transplantation (ACT)2.

    According to the latest guidelines by the working group "Tissue Regeneration" of the German Society of Orthopedic Surgery2, cartilage damages of over 2,5 cm in diameter can no longer be treated with simple microfracturing or OCT2 because implantation of autologous chondrocytes shows superior clinical outcomes4,5.

    Unfortunately all subjects recruited to the study received their surgery outside the window of the study duration. As such no subjects were successfully recruited or followed up according to trial protocols

    Has the registry been updated to include summary results?: No
    If yes - please enter the URL to summary results:
    If no – why not?: As no subjects were enrolled, there are no results to share
    Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: No
    If yes, describe or provide URLs to disseminated materials:
    If pending, date when dissemination is expected:
    If no, explain why you didn't follow it: No patients enrolled into study
    Have participants been informed of the results of the study?: No
    If yes, describe and/or provide URLs to materials shared and how they were shared:
    If pending, date when feedback is expected:
    If no, explain why they haven't: No patients enrolled into study
    Have you enabled sharing of study data with others?: No
    If yes, describe or provide URLs to how it has been shared:
    If no, explain why sharing hasn't been enabled: No patients enrolled into study
    Have you enabled sharing of tissue samples and associated data with others?: No
    If yes, describe or provide a URL:
    If no, explain why: No patients enrolled into study

  • REC name

    London - Surrey Borders Research Ethics Committee

  • REC reference

    21/LO/0859

  • Date of REC Opinion

    23 Dec 2021

  • REC opinion

    Further Information Favourable Opinion