Can a Two-Pronged surgical approach beat standard surgery for neck pain?

NCT ID NCT07721493

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether adding a posterior cervical fusion (using the CORUS PCSS 3D device) to the standard anterior cervical discectomy and fusion (ACDF) improves bone fusion success for people with two-level degenerative disc disease in the neck. About 225 adults with neck or arm pain, numbness, or weakness will be randomly assigned to receive either the combined procedure or ACDF alone. The main goal is to see if the combined approach leads to a higher rate of successful fusion at 12 months after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Circumferential Cervical Fusion (CCF) using CORUS PCSS 3D device and allograft bone matrix, compared to Anterior Cervical Discectomy and Fusion (ACDF) alone
What this could lead to
If successful, this combined surgical approach could offer a more durable fusion solution for patients with two-level cervical degenerative disc disease, potentially reducing the need for repeat surgeries.
What could go wrong
This is a surgical trial comparing two procedures; the added posterior fusion may increase operative time and risk without guaranteeing better outcomes. Results are limited to a specific device and patient population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. diagnosis of radiculopathy, myelopathy or myeloradiculopathy of the cervical spine, with pain, including at least one of the following: i. Neck and/or arm pain, ii. Decreased muscle strength, and iii. Abnormal sensation including hyperesthesia or hypoesthesia; and/or Abnormal reflexes. 2. radiographically determined pathology at the levels to be treated correlating to primary symptoms including at least one of the following: i. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc, ii. Degenerative spondylosis on MRI, and iii. Disc herniation on MRI. * NDI Score of ≥ 15/50 * Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for: 1. at least six weeks from radiculopathy or myeloradiculopathy symptom onset; or 2. have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment. * 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 Criteria: * 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: 1. daily, chronic use of oral steroids of 5 mg/day or greater. 2. use of short-term (less than 10 days) oral steroids at a daily dose greater than 40 mg within one month of the study procedure. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • The Orthopaedic Institute

    Paducah, Kentucky, 42001, United States

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