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

NCT07222787 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

DEVICE

Supplemental Posterior Fusion with Study 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.

DEVICE

Supplemental Posterior Fusion with Standard Technique

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

Sponsors & Collaborators

  • Providence Medical Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Erik M Summerside, PhD · Providence Medical Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-07-01
Completion
2029-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07222787 on ClinicalTrials.gov