EVOLVE
Research type
Research Study
Full title
Expandable Pedicle Screws versus Fenestrated Pedicle Screws Augmented with Polymethylmethacrylate (PMMA): Complications and Clinical Outcomes in Patients with Osteoporosis or Poor Bone Quality
IRAS ID
154357
Contact name
Robert Lee
Contact email
Sponsor organisation
Alphatec Spine
Clinicaltrials.gov Identifier
Research summary
The two types of screws that will be used in this study (OsseoScrew and any commercially available fenestrated screw augmented with PMMA) routinely used as part of standard of care in spinal fusion surgery which is a routine operation for patients who have spinal instability or deformity due to poor bone quality and require surgical intervention, a spinal fusion with instrumentation surgery to stabilise the spine especially in indivduals who are osteopenic. The study focuses on patients who, as part of their standard of care, are to undergo a spinal fusion. This is a post-market surveillance clinical study comparing two CE-marked spinal devices (both screws are routinely used as part of standard of care for spinal fusion surgeries). This study will assess the surgical outcomes and complications rates of two different types of screws, a OsseoScrew is a expandable screw system and a commercially available fenestrated screw augmented with Polymethylmetacrylate (PMMA), PMMA is a substance that remodel lost bone to ensure stability. Both types of screws are used routinely to stabilise the spine. The study will include up to 150 adults that will be recruited at 10 sites in Europe with osteoporosis or bone quality that will undergo a spinal fusion surgery and the patients will be followed-up for 24 months post spinal fusion surgery. As part of this study patients will undergo routine clinical and radiological evaluations along with patient satisfaction questionnaires. The data and radiological images captured during the study is routine and also part of standard of care.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/0191
Date of REC Opinion
4 Aug 2014
REC opinion
Further Information Favourable Opinion