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CORUS™ System for 2-level Cervical Degenerative Disease

This study is looking at a new way to treat degenerative disc disease (DDD) in the neck, which happens when the discs between your neck bones wear down. It compares two surgical approaches for two affected levels in your neck. One group will receive the standard Anterior Cervical Discectomy and Fusion (ACDF) procedure. The other group will receive a combination of ACDF and Posterior Cervical Fusion (PCF), using the CORUS™ Posterior Cervical Stabilization System 3D. The main goal is to see if the combined ACDF and PCF treatment leads to better bone fusion after 12 months compared to ACDF alone. You may be eligible if you are at least 18 years old and have been diagnosed with DDD at two specific levels in your neck causing pain or other symptoms. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 225 participants. It compares two different surgical treatments for degenerative disc disease.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months after surgery to assess fusion success.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07721493

Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Providence Medical Technology, Inc.
~225 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Circumferential Cervical Fusion (CCF)Anterior Cervical Discectomy and Fusion

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Superiority in Fusion Success in Treatment Arm (CCF) Compared to Control Arm (ACDF)
Measured over 12 months

Conditions

Degenerative Disc Disease(DDD)

Explore related trials

Intervertebral Disc Degenerative DisorderMyeloradiculopathyRadiculopathySpinal Cord Disorder

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Matt Jenkins · STUDY_DIRECTOR · Providence Medical Technology, Inc.

Who to contact

Matt Jenkins
[email protected]
805-450-4965
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

At least 18 years of age (Skeletally Mature)
Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 2 contiguous levels as determined by the following:
NDI Score of ≥ 15/50
Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
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 and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol;
Written informed consent provided by subject.

Exclusion

Has, in the Investigator's opinion, any disease or condition that would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity)
Active systemic infection or infection at the operative site
History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C
Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury that may prevent device placement
A prior spine surgery or pseudoarthrosis at the operative levels
Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention
Symptomatic DDD or significant cervical spondylosis at more than two levels
Diagnosis of Spondylolisthesis, grade \>2
Overt (Segmental) instability measured as a movement on dynamic flex/extend x-rays \> 3.5 mm
Congenital bony and/or spinal cord abnormalities that affect spinal stability
Diagnosis of Paget's disease, osteomalacia, or any other metabolic bone disease other than osteopenia
Osteoporosis, defined as either the SCORE or MORES ≥ 6 and a DEXA bone density measured T-score of ≤ -2.5
Active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and without clinical signs or symptoms of the malignancy for at least five years
Has an uncontrolled seizure disorder
Use of epidural steroids within 14 days prior to surgery
A concomitant condition requiring daily, high-dose oral and/or inhaled steroids. High dose steroid use is defined as:
Known allergy to titanium (Ti)
Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgical decompression
Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders)
Is pregnant or nursing at time of screening, or with plans to become pregnant throughout the duration of the study.
A current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) that required treatment
Long term use (\>6 months) of opioids (max. daily amount=120 mg morphine equivalents)
A mental illness or belongs to a vulnerable population, as determined by the Investigator (e.g., prisoner or developmentally disabled), that would compromise ability to provide informed consent or compliance with follow-up requirements
Any other condition or anatomy (e.g. fused facet) that makes posterior fusion treatment infeasible
Use of any other investigational drug or medical device within the last 30 days prior to surgery
Pending personal litigation relating to spinal injury (worker's compensation is not exclusionary)
Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.

What this trial measures

  • Superiority in Fusion Success in Treatment Arm (CCF) Compared to Control Arm (ACDF)12 months

    Superiority in the rate of fusion success in the treatment arm (CCF) as compared to the control arm (ACDF) at the 12-month visit. An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across endplates at all levels treated with no re-intervention.