Evaluation of the SOLUS Anterior Lumbar Interbody Fusion System (ALIF)
Research type
Research Study
Full title
Evaluation of the Alphatec SOLUS Anterior Lumbar Interbody Fusion System: a prospective, non-randomized trial with a two year clinical follow-up
IRAS ID
134022
Contact name
Nasir A Quraishi
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Research summary
For patients with diagnosed degenerative disease (DDD, in the lower back or lumbar region of the spine, spinal fusion is recommended, especially in cases where conservative therapy (such as physical therapy) has been ineffective. Spinal fusion is the joining of two or more vertebrae of the spine done in order to eliminate pain caused by DDD (amongst other pathologies). One approach for spinal fusion is the Anterior Lumbar Interbody Fusion (ALIF) technique whereby the affected disc is removed from a front (anterior) incision and replaced with a surgical device to maintain the curvature of the spine, and distances between discs.
For the purposes of this trial, we will be evaluating the use of the Solus device, created by Alphatec Spine and comparing this to devices from other manufacturers used in ALIF procedures. We will be recruiting 40 consenting adults who have been diagnosed with DDD and will undergo and ALIF procedure to trial the Solus device here at the Queen’s Medical Centre. Once patients have had this procedure, we will monitor their progress through medical imaging and questionnaires at various post-operative intervals.
The structure of this study follows the same standard practice of care for any patient requiring an ALIF procedure in our hospital, with the only difference being the device used. Compared to other devices, Solus is very easy to insert, and requires a smaller incision, thereby reducing the operating time for ALIF. It is made from polyetheretherketone (PEEK), a thermoplastic which also makes it compatible with imaging techniques such as X-ray, unlike other devices made from titanium. Results from this study will determine if Solus will be the standard device used for ALIF procedures.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
13/EM/0436
Date of REC Opinion
16 Dec 2013
REC opinion
Favourable Opinion