Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes

NCT07222787 | Recruiting FDA Device

• 1 other identifier: PMT0004
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 8

Brief Summary

The goal of this clinical trial is to assess the safety and effectiveness of the study device, CORUS-LX, as an adjunct to lumbar interbody fusion, when used in combination with pedicle screw and rod constructs for the treatment of lumbosacral degenerative disease in patients requiring 2 level (L4-S1) lumbar fusion, for the treatment of symptomatic degenerative lumbosacral disc disease. The main questions it aims to answer are: Is there fusion success at the treated posterior anatomy of each level? Is there an absence of major adverse device related events? Is there an absence of injections (steroid, facet joint, nerve block) or subsequent revision surgery at index levels for symptoms related to back or leg pain? Researchers will compare a control arm to the treatment arm to see if research results vary from standard minimally invasive supplemental posterior fusion. Eligible participants will undergo one of the below interventions:

• Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with supplemental posterior fusion performed using the study device, including pedicle screw and rod fixation.
• Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard minimally invasive supplemental posterior fusion including pedicle screw and rod fixation. Participants will also be asked to read, understand, and sign the informed consent, attend a Screening/Baseline visit, undergo surgery for their designated intervention, and participate in 5 additional study visits where they will complete surveys for patient reported outcomes and SOC procedures. These visits will occur at the below intervals (based upon surgery day as day 0):
• 6 weeks
• 3 months
• 6 months
• 12 months
• 24 months

Conditions

Radiculopathy Lumbar; Degenerative Lumbar Disc Disease

Outcome Measures

Primary Outcomes (3)

• Proportion of participants with fusion success at the treated posterior anatomy of each level.

  An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across the posterior anatomy identified at both index levels determined using thin-slice CT and assessed by a third-party core imaging laboratory.

  12 months post procedure

• Proportion of participants with freedom from serious adverse event with definite relationship to treatment devices (interbody or posterior devices).

  The seriousness and relationship of each adverse event will be adjudicated by a clinical events committee. A subject will be considered a primary endpoint failure if an adverse event is determined by the committee to be serious and to have a relationship to any of the devices used in the procedure including both interbody and posterior devices.

  12 months post procedure

• Proportion of Participants with freedom from injections (steroid, facet joint, nerve block) or subsequent revision surgery at index levels for symptoms related to back or leg pain.

  A subject will be considered a primary endpoint failure if they require injections or subsequent revision surgery to treat new or recurrent symptoms of back or leg pain after their index surgery.

  12 months post procedure

Secondary Outcomes (4)

• Proportion of participants with the presence of Interbody bridging bone.

  12 month visit

• Differences in average segmental range of motion of the treated levels

  12 month visit

• Differences in average change in disc height of the treated levels

  12 month visit

• Proportion of participants with freedom from injections (steroid, facet joint, nerve block) or subsequent revision surgery at treated levels for symptoms related to back or leg pain.

  through 24 month visit

Study Arms (2)

Standard Supplemental Posterior Fusion Technique

ACTIVE COMPARATOR

Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard supplemental posterior fusion including pedicle screw and rod fixation.

Device: Supplemental Posterior Fusion with Standard Technique

Supplemental Posterior Fusion with Study Device

EXPERIMENTAL

Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with supplemental posterior fusion performed using the study device, including pedicle screw and rod fixation.

Device: Supplemental Posterior Fusion with Study Device

Interventions

Supplemental Posterior Fusion with Study Device DEVICE

Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with supplemental posterior fusion performed using the Study Device, including pedicle screw and rod fixation.

Supplemental Posterior Fusion with Study Device

Supplemental Posterior Fusion with Standard Technique DEVICE

Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard minimally invasive supplemental posterior fusion including pedicle screw and rod fixation.

Standard Supplemental Posterior Fusion Technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years (Skeletally Mature)
• Indicated for lumbar interbody fusion for treatment of degenerative lumbosacral disease at two contiguous disc levels between L4-S1 as determined by the following:
• a) Diagnosis of radiculopathy of the lumbar spine, with pain, including at least one of the following: i) Leg and/or buttock pain, weakness, numbness, or paresthesia ii) Low back pain iii) Neurogenic claudication b) Radiographically determined pathology (CT, MRI, X-rays) at the levels to be treated correlating to primary symptoms including at least one of the following: i) Decreased disc height in comparison to a normal adjacent disc. ii) Degenerative instability ≤ grade 1 spondylolisthesis (\<25% slip). iii) Recurrent disc herniation. iv) Central and/or foraminal stenosis.
• Oswestry Disability Index Score of \> 40/100 (Severe Disability).
• Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
• At least six weeks from symptom onset; or
• Have the presence of progressive symptoms or signs of nerve root/ spinal cord compression despite continued non-operative conservative treatment.
• Reported to be medically cleared for surgery.
• Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms
• Willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
• Written informed consent provided by subject.

You may not qualify if:

• Any disease or condition that, in the investigator's opinion, would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity).
• Any anatomy or condition that makes posterior fusion treatment infeasible (e.g. fused facets).
• Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders).
• Active systemic infection or infection at the operative site.
• Anticipated treatment for active systemic infection, including HIV or Hepatitis C.
• Previous trauma to any of the L3 to S1 levels resulting in significant bony or disco-ligamentous lumbar spine injury that may prevent device placements.
• Prior instrumented surgery or pseudoarthrosis at the operative or adjacent levels.
• Indicated for or history of laminectomy at any of the index or adjacent levels
• Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgery
• Leg, buttocks, or back pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention.
• Symptomatic disc degeneration requiring surgical intervention at more or less than two levels.
• Diagnosis of spondylolisthesis, grade \>1.
• Diagnosis of lytic spondylolisthesis
• Diagnosis of iatrogenic, traumatic, or dysplastic spondylolisthesis
• Congenital bony and/or spinal cord abnormalities affecting spinal stability.

Sponsors & Collaborators

• Providence Medical Technology, Inc.: lead

Study Sites (8)

Barrow Brain & Spine

Scottsdale, Arizona, 85251, United States

RECRUITING

HonorHealth Neurology

Scottsdale, Arizona, 85251, United States

RECRUITING

California Spine

Los Angeles, California, 90033, United States

RECRUITING

Orthopaedic Spine Institute

Hinsdale, Illinois, 60521, United States

RECRUITING

Olympia Neurological Institute

Austin, Texas, 78745, United States

NOT YET RECRUITING

Spine Physician Institute

Dallas, Texas, 75234, United States

RECRUITING

American Neurospine Institute

Frisco, Texas, 75033, United States

NOT YET RECRUITING

Huntsman Spine

Salt Lake City, Utah, 84124, United States

RECRUITING

Related Links

• Services US Department of Health and Human. Guidance document for the preparation of IDEs for spinal systems. Washington (DC): Food and Drug Administration Center for Devices and Radiological Health. 2000.

Study Officials

• Erik M Summerside, PhD

  Providence Medical Technology

  STUDY DIRECTOR

Central Study Contacts

Erik M Summerside, PhD

CONTACT

(415) 923-9376; ILIF@providencemt.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to their assignment through the day of surgery, however will be informed of what treatment they received once the surgery is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 30, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (8)