Safety study of dCELL® Meniscus Version 01

• Research type

  Research Study

• Full title

  An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus

• IRAS ID

  151489

• Contact name

  David Houlihan-Burne

• Contact email

  mrhburne@3riversclinic.co.uk

• Sponsor organisation

  TRx Orthopaedics Ltd.

• Research summary

  This is a prospective, non-randomized, single arm, open-label clinical investigation to assess the safety and performance of implanting the dCELL® Meniscus device to treat patients with chronic knee pain following failed previous meniscus repair or partial meniscectomy.
  The device is a porcine (pig based) derived meniscus tissue graft, called the dCELL® Meniscus.
  The study will involve 8 centers in Europe including 3 in the UK. Globally 60 patients will be implanted with the dCell® Meniscus device. Patients will be enrolled who suffer from chronic knee pain despite having previous meniscus repairs and/or partial removal of a portion of their meniscus. Patients are aged between 18 and 50 years with osteoarthritis scale less than 3 on Kellgren Lawrence scale and a stable, well aligned knee with ligament laxity of Grade II or less and VAS Pain score 40 or higher. Total duration of the study is 30 months, 6 months enrollment and a follow-up phase of 24 months.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  14/LO/0775

• Date of REC Opinion

  22 Jul 2014

• REC opinion

  Further Information Favourable Opinion