RWE Spine Study

• Research type

  Research Study

• Full title

  A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices (RWE Spine Study)

• IRAS ID

  320974

• Contact name

  Kyriakos Giannoulis

• Contact email

  kyriakos.giannoulis@uhs.nhs.uk

• Sponsor organisation

  Orthofix S.r.l

• Clinicaltrials.gov Identifier

  NCT05082090

• Duration of Study in the UK

  10 years, 0 months, 30 days

• Research summary

  RWE Spine Study is a retrospective and prospective multi-center, open label observational study to collect device performance data in the real world use context of Orthofix spine devices for the treatment of patients with spine injuries and/or disorders.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  23/EE/0049

• Date of REC Opinion

  3 Mar 2023

• REC opinion

  Unfavourable Opinion