Become a Site for our Lumbar Fusion Clinical Study

Providence is inviting spine surgeons to participate in a prospective, randomized clinical study focused on the CORUS-LX System, which was recently cleared by the FDA for tissue-sparing posterior lumbar fusion and supplemental fixation to lumbar interbody fusion.

This study aims to evaluate the efficacy of the CORUS-LX System in comparison to traditional posterior fusion techniques for the treatment of degenerative lumbosacral disease.

CORUS Spinal System-LX with CAVUX FFS-LX in lateral lumbar spine.

Study Background

Current Treatment Landscape:

Open posterolateral fusion, combined with interbody discectomy and fusion, has been a reliable method for achieving arthrodesis in degenerative lumbosacral disease, one that allows good access and preparation of the fusion bed. However, the challenges with this approach include damage to surrounding soft tissues and bleeding.

Percutaneous pedicle screws are a popular option for adding supplemental fixation and stabilizaton to a lumbar interbody fusion. However, their percutaneous approach limits the extent of fusion bed preparation.

CORUS-LX

The CORUS-LX System & Device provides a tissue-sparing solution for preparing fusion beds around the facet space and stabilizing the facet joint in addition to percutaneous pedicle screw and rod fixation. Unlike percutaneous pedicle screws, CORUS-LX allows for robust decortication, bone graft delivery, and serves as a dedicated posterolateral fusion device.

CORUS-LX is compatible with surgical navigation.

A close up of CAVUX FFS_LX in the lumbar spine.

Study Details

Primary Endpoint:

The study’s primary endpoint is to demonstrate statistical superiority in arthrodesis rates across the posterior anatomy in the treatment arm compared to the control arm.

Additional Data Collection

Arthrodesis rates at the interbody spaces.
Device-related adverse events and failures.
Subsequent surgical revisions.
Patient-reported outcomes and return-to-work measures (assessed up to 24 months post-surgery).

Inclusion Criteria

Patients with degenerative lumbosacral disease, diagnosed at L4-S1 (2 levels).
Indicated for lumbar interbody fusion supplemented with pedicle screw and rod fixation.

Exclusion Criteria

Prior instrumentation at the index or adjacent levels.
Fused facet or facet hypertrophy that prevents device implantation.
Osteoporosis diagnosis.

Why Join This Study?

Advancing Patient Care:

As a clinical investigator, you’ll be part of a rigorous, randomized controlled trial designed to potentially enhance long-term, sustained stability for patients undergoing lumbar fusion.

This is a high-volume procedure with significant clinical impact, and your involvement could help define the future of lumbar fusion techniques. This is a unique opportunity to directly contribute to advancing surgical techniques that could significantly reduce complications and improve outcomes for patients with degenerative lumbosacral disease.

Collaboration with Industry Leaders:

This study is an opportunity to collaborate with other clinical thought leaders in the field of spine surgery, gaining valuable insights into the potential of a tissue-sparing lumbar fusion system.

Innovative Technology + Surgical Navigation:

The CORUS-LX system offers a novel approach to lumbar fusion with the potential for improved patient outcomes. The study utilizes the latest navigation technology for the placement of posterior instrumentation, enhancing precision and surgical outcomes.

State-of-the-Art Data Collection:

Investigators and clinical administrators will have access to a custom app developed by Providence Medical Technology to streamline the study administration and data collection process, enhancing efficiency and reducing the administrative burden on your practice.

Past Success:

Providence has a proven track record of successful RCTs. Our recently completed FUSE Study (NCT04229017) involved over 200 subjects at 18 sites, making it the largest prospective randomized study to evaluate 3-level cervical fusion.

Next Steps:

If you are interested in learning more about the study or becoming a clinical investigator, please enter your information to start the dialogue. We’ll follow up with additional details on study protocols, timelines, and enrollment procedures.

Learn More about Becoming a Clinical Investigator

A. Schedule a Time with our Principal Scientist, Erik Summerside, PhD

View Calendar

B. Please have someone contact me

Not Ready to Connect?
We invite you to learn more about the technology under evaluation via a brief online course.

Access Course: Introduction to Navigated Lumbar Fusion with CORUS-LX

INDICATIONS FOR USE, CORUS™-LX LevelOne:

A. CORUS SPINAL SYSTEM-LX:
The CORUS Spinal System-LX is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.

B. CORUS-LX IMPLANT:
CORUS-LX Implant is an integrated construct comprised of a CAVUX Cage-LX and an ALLY Bone Screw-LX. CORUS-LX Implant is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct.

CORUS-LX Implant is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s).
CORUS-LX Implant is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

C. DiViNE DIRECT VISUALIZATION SYSTEM-LX:
DiViNE Direct Visualization System-LX is a set of instruments indicated to make the interior of a joint visible and/or to perform surgery within a joint.

As with all medical devices, there are risks and considerations to device use. Please refer to the device labeling for a full discussion of potential risks, contraindications, warnings, precautions, and instructions for use. Rx only.
View Product Safety Information

MKT-PMT-740 Rev 1