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Providence Medical Technology enrolled the first patients in its prospective, randomized controlled trial (RCT) evaluating the CORUS-LX System for the treatment of degenerative lumbosacral disease. This multi-center RCT will enroll subjects indicated for two-level interbody fusion with supplemental percutaneous pedicle screw fixation and posterior fusion. Subjects will be randomized to receive posterior fusion either with the CORUS-LX System or with the surgeon’s standard posterior fusion technique.
A key component of the study involves using the CORUS-LX System with modern surgical workflows, specifically the surgical navigation systems from Medtronic and Globus Medical. By combining CORUS-LX with these leading navigation systems, surgeons can achieve high-precision placement of posterior implants through a tissue-sparing corridor.
CORUS-LX is an integrated construct comprising a stabilizer and two screws that is FDA-cleared for tissue-sparing posterior lumbar fusion and supplemental fixation. The system allows for extensive decortication and bone graft retention, serving as a dedicated fusion device that also provides significant stabilization.
This study is designed to replicate the rigorous clinical validation established by Providence’s FUSE study, which was the largest prospective RCT to evaluate three-level cervical fusion. Evidence from FUSE demonstrated that adding CORUS PCSS to an anterior cervical fusion delivers clinically superior composite fusion rates to anterior fusion alone. This new trial seeks to provide similar high-level insights for the lumbar spine.
The trial aims to establish a new benchmark for two-level lumbar treatment options by comparing a treatment arm (CORUS-LX + Interbody Fusion + Pedicle Screws) against the current gold standard (Interbody Fusion + Pedicle Screws alone). The hypothesis is that the CORUS-LX construct will be a superior option for patients requiring L4-S1 lumbar fusion. The primary endpoint is to demonstrate superior 12-month composite fusion rates, with additional data collection on patient-reported outcomes and return-to-work measures through 24 months.
“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 3-level patients,” said Scott Lynch, Chief Product Officer of Providence Medical Technology. “We believe this new trial will demonstrate that the CORUS-LX System provides similar biological and mechanical advantages for the lumbar spine.”
Providence Medical Technology enrolled the first patients in its prospective, randomized controlled trial (RCT) evaluating the CORUS-LX System for the treatment of degenerative lumbosacral disease. This multi-center RCT will enroll subjects indicated for two-level interbody fusion with supplemental percutaneous pedicle screw fixation and...
Providence Medical Technology enrolled the first patients in its prospective, randomized controlled trial (RCT) evaluating the CORUS-LX System for the treatment of degenerative lumbosacral disease. This multi-center RCT will enroll subjects indicated for two-level interbody fusion with supplemental percutaneous pedicle screw fixation and posterior fusion. Subjects will be randomized to receive posterior fusion either with the CORUS-LX System or with the surgeon’s standard posterior fusion technique.
A key component of the study involves using the CORUS-LX System with modern surgical workflows, specifically the surgical navigation systems from Medtronic and Globus Medical. By combining CORUS-LX with these leading navigation systems, surgeons can achieve high-precision placement of posterior implants through a tissue-sparing corridor.
CORUS-LX is an integrated construct comprising a stabilizer and two screws that is FDA-cleared for tissue-sparing posterior lumbar fusion and supplemental fixation. The system allows for extensive decortication and bone graft retention, serving as a dedicated fusion device that also provides significant stabilization.
This study is designed to replicate the rigorous clinical validation established by Providence’s FUSE study, which was the largest prospective RCT to evaluate three-level cervical fusion. Evidence from FUSE demonstrated that adding CORUS PCSS to an anterior cervical fusion delivers clinically superior composite fusion rates to anterior fusion alone. This new trial seeks to provide similar high-level insights for the lumbar spine.
The trial aims to establish a new benchmark for two-level lumbar treatment options by comparing a treatment arm (CORUS-LX + Interbody Fusion + Pedicle Screws) against the current gold standard (Interbody Fusion + Pedicle Screws alone). The hypothesis is that the CORUS-LX construct will be a superior option for patients requiring L4-S1 lumbar fusion. The primary endpoint is to demonstrate superior 12-month composite fusion rates, with additional data collection on patient-reported outcomes and return-to-work measures through 24 months.
“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 3-level patients,” said Scott Lynch, Chief Product Officer of Providence Medical Technology. “We believe this new trial will demonstrate that the CORUS-LX System provides similar biological and mechanical advantages for the lumbar spine.”
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
