Providence Medical Technology has enrolled the first subjects in its prospective, randomised controlled trial (RCT) assessing the CORUS-LX system to treat degenerative lumbosacral disease.
The multi-centre trial will include patients indicated for two-level interbody fusion with supplemental percutaneous pedicle screw fixation and posterior fusion.
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They will be randomised to receive posterior fusion using either the CORUS-LX system or the standard posterior fusion method of the surgeon.
Dr Kade Huntsman of Huntsman Spinal Clinic in Utah, US, was the first to treat an enrolled subject with the study device, using a circumferential fusion approach.
This method integrates lumbar interbody fusion with percutaneous pedicle screws and the CORUS-LX system for fusion bed preparation and additional posterior stabilisation.
Drs Mohsin Fidai and Vivek Mohan joined Dr Huntsman as early-enrolling investigators in the study, which will follow subjects through 2027.
The study aims to replicate the rigorous clinical validation process seen in Providence’s prior FUSE study.
The study showed that incorporating CORUS PCSS with anterior cervical fusion yielded superior composite fusion rates compared to anterior fusion alone.
Providence Medical Technology’s chief product officer Scott Lynch said: “The FUSE study was a turning point for cervical spine surgery because it clearly demonstrated that tissue-sparing, supplemental posterior fixation improves patient outcomes for three-level patients.
“We believe this new trial will demonstrate that the CORUS-LX system provides similar biological and mechanical advantages for the lumbar spine.”
The company designed the RCT as a statistical superiority trial, comparing a treatment arm consisting of CORUS-LX plus interbody fusion and pedicle screws against interbody fusion and pedicle screws alone.
The primary endpoint of the trial is to show superior 12-month composite fusion rates while patient-reported outcomes and return-to-work data will be collected through 24 months.
Additionally, the clinical trial incorporates surgical navigation systems from Globus Medical and Medtronic to enable high-precision placement of posterior implants using a tissue-sparing approach.
The CORUS-LX system addresses limitations in both decortication and bone graft delivery that can occur with percutaneous screw fixation alone.
