NCT07222787: ILIF

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

ENROLLING BY INVITATION NA Last updated 16 April 2026

What this trial tests

NA trial testing Supplemental Posterior Fusion with Study Device in Radiculopathy Lumbar in 250 participants. Enrolling by invitation.

Timeline

1 December 2025

Primary endpoint
1 July 2028

1 July 2029

Quick facts

Lead sponsor	Providence Medical Technology, Inc.
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	250
Start date	1 December 2025
Primary completion	1 July 2028
Estimated completion	1 July 2029
Sites	7 locations across United States

Drugs / interventions tested

• Supplemental Posterior Fusion with Study Device
• Supplemental Posterior Fusion with Standard Technique

Conditions studied

• Radiculopathy Lumbar — all drugs for Radiculopathy Lumbar →
• Degenerative Lumbar Disc Disease — all drugs for Degenerative Lumbar Disc Disease →

Sponsor

Providence Medical Technology, Inc.

Who can join

Adults 18 to 80, any sex, with Radiculopathy Lumbar or Degenerative Lumbar Disc Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.