PRO-14023

• Research type

  Research Study

• Full title

  A Clinical Study of the Safety and Performance of the Dymicron Triadyme Cervical Disc Replacement Prosthesis

• IRAS ID

  180943

• Contact name

  Kia Rezajooi

• Contact email

  Kia.Rezajooi@rnoh.nhs.uk

• Sponsor organisation

  Dymicron

• Duration of Study in the UK

  2 years, 6 months, 22 days

• Research summary

  The purpose of this study is to evaluate the safety and efficacy of Dymicron’s polycrystalline diamond compact Triadyme cervical disc replacement. The device is a CE marked device and will be used during the study for it's intended purposes.
  Patients who would be clinically required to undertake disk replacement will be recruited to take part in this study, and will be followed up to assess their progress over 24 months.
  During the study, patient reported outcome measures will be collected to see how individual patients are progressing and what if any improvement has been made to their pain (Visual Analog Scale - VAS) and their movement (Neck Disability Index - NDI). Radiological assessments will also be collected to look at the range of motion and its improvement.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  15/LO/1853

• Date of REC Opinion

  10 Feb 2016

• REC opinion

  Further Information Favourable Opinion