A STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF TOPS SYSTEM.

• Research type

  Research Study

• Full title

  A STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE PREMIA SPINE TOPS (TOTAL POSTERIOR SPINE SYSTEM) SYSTEM.

• IRAS ID

  139864

• Contact name

  RON SACHER

• Contact email

  RONSACHER@PREMIASPINE.COM

• Sponsor organisation

  PREMIA SPINE

• Clinicaltrials.gov Identifier

  NCT01933607

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  The purpose of this prospective clinical study is to establish the safety and effectiveness of the TOPS(TM) system,(Total Posterior Spinal System). TOPS is a motion preservation device that can be implanted following decompression (removal of bone and soft tissue), in the treatment of lower back and sciatic pain caused by slipped disk (DEGENERATIVE SPONDYLOLISTHESIS) and / or narrowing of the spinal canal (SPINAL STENOSIS) at one vertebral level between L3 and L5, without any adjacent segment that requires treatment. Up to 10 (Ten) patients will be enrolled to the study. All study devices are CE approved.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  14/WM/1135

• Date of REC Opinion

  23 Oct 2014

• REC opinion

  Further Information Favourable Opinion