TOPS System Post Marketing Evaluation

• Research type

  Research Study

• Full title

  Single-Arm Post-Marketing Evaluation for improvement in function and pain for lumbar spinal stenosis and spondylolisthesis with the TOPS System

• IRAS ID

  152788

• Contact name

  Masood Shafafy

• Contact email

  masood.shafafy@nuh.nhs.uk

• Sponsor organisation

  Premia Spine Ltd

• ISRCTN Number

  ISRCTN47205504

• Clinicaltrials.gov Identifier

  N/A, N/A

• Research summary

  The Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System. Ten patients who are scheduled to undergo spinal surgery as part of their medical treatment and comply with the study inclusion / exclusion criteria will be recruited. Patients will undergo standard surgical decompression prior to device implantation.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  14/WM/1041

• Date of REC Opinion

  29 Aug 2014

• REC opinion

  Further Information Favourable Opinion