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NCT07222787 · ClinicalTrials.gov registry record · NA
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
A NA study, sponsored by Providence Medical Technology.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
NCT07222787: Recruiting NA study, sponsored by Providence Medical Technology.
NCT07222787 is a NA study that is actively recruiting participants, run by Providence Medical Technology. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07222787, a NA study, is actively recruiting participants, sponsored by Providence Medical Technology.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
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
Primary Outcome
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.
Interventions
- DEVICE Supplemental Posterior Fusion with Study Device
- DEVICE Supplemental Posterior Fusion with Standard Technique
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2029-07-01 |
| Phase | NA |
What NCT07222787 shows while recruiting
NCT07222787 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Supplemental Posterior Fusion with Study Device is the first listed.
NCT07222787 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07222787 about?
NCT07222787 is a clinical study titled "Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes". 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...
What is the current status of trial NCT07222787?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2025-12-01. Estimated completion is 2029-07-01.
What interventions are being tested in trial NCT07222787?
The interventions under investigation include: Supplemental Posterior Fusion with Study Device (DEVICE), Supplemental Posterior Fusion with Standard Technique (DEVICE).
Who is sponsoring clinical trial NCT07222787?
This trial is sponsored by Providence Medical Technology, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07222787's enrollment target sits among peer trials
250 410th of 2000 higher than 1,567 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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