250 Participants NeededMy employer runs this trial

CORUS-LX System for Degenerative Disc Disease

(ILIF Trial)

Recruiting at 10 trial locations
EM
MJ
Overseen ByMatt Jenkins
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new device for back surgeries in individuals with degenerative disc disease in the lower back. Researchers aim to determine if the device aids spinal fusion (joining two or more bones) while minimizing complications and reducing the need for additional treatments related to back pain. The trial compares the new device with the standard method used in these surgeries, specifically examining Supplemental Posterior Fusion with the study device versus the standard technique. Individuals experiencing persistent back or leg pain due to degenerative disc disease, who have not found relief with other treatments, might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future treatment options.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using high-dose oral steroids or long-term opioids, you may not be eligible to participate.

What prior data suggests that the CORUS-LX system is safe for treating degenerative disc disease?

Previous studies have shown that lumbar interbody fusion procedures, like the one used in this trial, are generally safe for patients with degenerative disc disease. Research indicates that these procedures, when using certain tools such as specially made spacers and devices that stabilize the spine, are effective and well-tolerated.

The CORUS-LX system, the device under study in this trial, is designed to enhance these standard procedures. Ongoing research confirms its safety and effectiveness, and initial findings suggest it does not increase the risk of major side effects.

Current evidence suggests this treatment is as safe as other similar spinal fusion techniques. Participants can feel reassured that past studies have demonstrated a history of safety for this treatment.12345

Why are researchers excited about this trial?

Researchers are excited about the CORUS-LX system for treating degenerative disc disease because it offers a potentially improved technique for spinal fusion. Unlike the standard method, which relies solely on traditional tools like pedicle screws and rods, the study device aims to enhance the fusion process through its unique design. This could lead to better stabilization of the spine and possibly faster recovery times for patients. By refining the way spinal segments are fused, this new approach might improve outcomes and reduce complications, making it a promising option for those suffering from this debilitating condition.

What evidence suggests that the CORUS-LX system is effective for degenerative disc disease?

Research has shown that lumbar interbody fusion, combined with posterior fusion, can effectively treat degenerative disc disease. Studies indicate that this surgery often successfully joins spine segments, reducing pain and improving mobility. In some cases, interbody fusion results match or surpass those of other treatments. In this trial, participants will receive either the standard supplemental posterior fusion technique or the supplemental posterior fusion with the study device, the CORUS-LX system. The CORUS-LX system aims to enhance results by potentially providing better support during healing. Early findings from other studies suggest that these fusion techniques can help manage pain and improve the quality of life for individuals with back problems.23567

Who Is on the Research Team?

MJ

Matt Jenkins

Principal Investigator

Providence Medical Technology

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with severe lower back and/or leg pain due to lumbar disc disease, confirmed by imaging. Participants must have tried other treatments for at least six weeks or have worsening symptoms, be cleared for surgery, able to follow study instructions, and willing to attend all follow-up visits.

Inclusion Criteria

I am between 18 and 80 years old.
I have been diagnosed with radiculopathy in my lower back and have symptoms like pain or numbness.
My back pain severely limits my daily activities.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants undergo two-level lumbar interbody fusion at L4-L5 & L5-S1 segments, with supplemental posterior fusion using either the study device or standard technique

Surgery day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months

24 months
5 visits (in-person)

Long-term follow-up

Participants are monitored for long-term outcomes and adverse events

24 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study compares two surgical methods for spinal fusion in the lower back: one uses the new CORUS-LX device along with standard hardware (screws and rods), while the other uses only standard minimally invasive techniques. Patients are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Supplemental Posterior Fusion with Study DeviceExperimental Treatment1 Intervention
Group II: Standard Supplemental Posterior Fusion TechniqueActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Providence Medical Technology, Inc.

Lead Sponsor

Trials
3
Recruited
240+

Citations

clinical-outcomes-of-lumbar-degenerative-disc-disease- ...

The patients in this clinical series had outcomes equal or superior to the outcomes in previous series. Posterior lumbar interbody fusion (PLIF), original- ly ...

Lumbar Disc Replacement Versus Interbody Fusion: Meta- ...

Both LDR and IBF procedures offer similar results in managing CLBP, considering OR time, EBL, LOS, complication rates, reoperations, and leg pain.

Supplemental Evidence and Data Request on The ...

We are looking for studies that report on The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine.

Post-market Safety and Effectiveness of the CORUS-LX ...

This randomized controlled trial was designed to compare outcomes in subjects treated with interbody fusion including supplemental posterior fusion for the ...

Outcome Comparison of Posterior Lumbar Fusion Versus ...

PLF and PLIF are two widely used techniques, yet their comparative effectiveness remains debated. Evaluating both approaches can inform optimal ...

Safety of Lumbar Interbody Fusion Procedures for ... - PMC

We identified 14 studies involving 921 participants with LDDD. Pooled result showed that open PLIF (OPLIF) leads to significantly higher overall adverse event ...

A Multicenter Study to Evaluate the Safety and Efficacy of ...

This safety and efficacy study suggests that the anterior I/F Cage is a safe surgical option in the treatment of single-level lumbar degenerative disc disease.