Fibrofix Meniscus

• Research type

  Research Study

• Full title

  A Prospective Open-Label Study to Evaluate the Safety of the Meniscal Repair Scaffold, FibroFix™ Meniscus, in the Treatment of Meniscal Defects

• IRAS ID

  159674

• Contact name

  Dr Nick Skaer

• Contact email

  n.skaer@orthox.co.uk

• Sponsor organisation

  Orthox Limited

• Clinicaltrials.gov Identifier

  NCT02205645

• Duration of Study in the UK

  7 years, 0 months, 0 days

• Research summary

  This is the first human study of the FibroFix™ Meniscus scaffold, the primary aim of which is to assess safety in adults with significant medial meniscal defects either created by partial meniscectomy or patients with medial meniscal defects following previous meniscectomy. The study will include some non-invasive outcome measures such as pain relief, range of motion, functional outcome scores, assessment of subsequent degenerative change in the knee by plain radiography and evidence of integration and implant stability evaluated by MRI.

• REC name

  South West - Frenchay Research Ethics Committee

• REC reference

  14/SW/1120

• Date of REC Opinion

  12 Jan 2015

• REC opinion

  Further Information Favourable Opinion