Degenerative Disc Disease(DDD)SECONDNCT07721493
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
A study testing Circumferential Cervical Fusion (CCF) and Anterior Cervical Discectomy and Fusion in people with Degenerative Disc Disease(DDD), run by Providence Medical Technology, Inc. at 1 site in United States.
Trial summary
The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF) procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease(DDD)
- What is being tested?
- Circumferential Cervical Fusion (CCF) and Anterior Cervical Discectomy and Fusion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 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:
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- at least six weeks from radiculopathy or myeloradiculopathy symptom onset; or
- 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.
Who cannot join
- 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
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- 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:
- daily, chronic use of oral steroids of 5 mg/day or greater.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Assessment of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) to Determine Superiority to ANterior Cervical Discectomy and Fusion (ACDF) in the Treatment of 2-Level Cervical Degenerative Disease
The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF) procedures.
The primary outcome measure is the rate of fusion success in the investigational treatment arm (ACDF + PCF) compared with the control arm (ACDF alone) at the 12-month follow-up visit.
Researchers will compare the investigational treatment arm (ACDF + PCF) to the control arm (ACDF alone) to assess superiority in terms of fusion success rate.
Read the detailed description
Degenerative disc disease (DDD) of the neck occurs when the discs between the bones of the spine wear down over time. These discs normally act as cushions and help the neck move. When they break down, the space between the bones can narrow and put pressure on nearby nerves or the spinal cord. This can cause pain in the neck, shoulders, and arms.
One common surgical treatment is called Anterior Cervical Discectomy and Fusion (ACDF). In this procedure, the surgeon approaches the spine from the front of the neck, removes the damaged disc, relieves pressure on the nerves, and fuses the bones together. Another option is Posterior Cervical Fusion (PCF), which is done from the back of the neck. In some cases, both procedures are combined to provide more stability and support healing. The purpose of this study is to evaluate whether combining ACDF and PCF leads to better outcomes than ACDF alone in patients with two-level cervical degenerative disc disease.
Participants in this study will be assigned to one of two groups:
One group will receive ACDF alone (standard treatment) The other group will receive a combination of ACDF and PCF (investigational treatment) The main goal of the study is to compare how well the bones fuse together in each group at 12 months after surgery. The study will assess whether the combined approach (ACDF + PCF) results in a higher rate of successful fusion compared to ACDF alone.
- Conditions
- Degenerative Disc Disease(DDD)
- Being tested
- Circumferential Cervical Fusion (CCF), Anterior Cervical Discectomy and Fusion
- Keywords
- cervical spine, myelopathy, radiculopathy, cervical spine fusion, circumferential cervical fusion, degenerative disc disease, 2-Level Cervical Degenerative Disease, Anterior Cervical Discectomy and Fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Cord Diseases, Radiculopathy, Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumferential Cervical Fusion (CCF)Device
Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF) performed during the same surgical procedure, irrespective of order. The PCF procedure is performed using CORUS™ Spinal System-X to access and prepare the joint for fusion, followed by placement of PCSS 3D and delivery of an allograft demineralized bone matrix (DBM).
Anterior Cervical Discectomy and FusionProcedure or surgery
ACDF is performed using standard instruments and completed with a titanium interbody implant and anterior semi-constrained plate. The plate is intended to stabilize the treated levels until fusion occurs.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Active comparator | Anterior Cervical Discectomy and Fusion (ACDF), which is a standard of care procedure Receives: Procedure: Anterior Cervical Discectomy and Fusion |
| Circumferential Cervical Fusion (CCF) | Experimental | Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF) Receives: Device: Circumferential Cervical Fusion (CCF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority in Fusion Success in Treatment Arm (CCF) Compared to Control Arm (ACDF)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc Disease(DDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, multicenter study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Medical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matt Jenkins, Study director, Providence Medical Technology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721493
- Sponsor's protocol ID
- CLN-PMT-149
- Acronym
- SECOND
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) to Determine Superiority to ANterior Cervical Discectomy and Fusion (ACDF) in the Treatment of 2-Level Cervical Degenerative Disease
- ClinicalTrials.gov ID
- NCT07721493
- Acronym / sponsor ID
- SECOND / CLN-PMT-149
- Conditions
- Degenerative Disc Disease(DDD)
- Keywords
- cervical spine, myelopathy, radiculopathy, cervical spine fusion, circumferential cervical fusion, degenerative disc disease, 2-Level Cervical Degenerative Disease, Anterior Cervical Discectomy and Fusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Providence Medical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF) procedures.
The primary outcome measure is the rate of fusion success in the investigational treatment arm (ACDF + PCF) compared with the control arm (ACDF alone) at the 12-month follow-up visit.
Researchers will compare the investigational treatment arm (ACDF + PCF) to the control arm (ACDF alone) to assess superiority in terms of fusion success rate.
Detailed description
Degenerative disc disease (DDD) of the neck occurs when the discs between the bones of the spine wear down over time. These discs normally act as cushions and help the neck move. When they break down, the space between the bones can narrow and put pressure on nearby nerves or the spinal cord. This can cause pain in the neck, shoulders, and arms.
One common surgical treatment is called Anterior Cervical Discectomy and Fusion (ACDF). In this procedure, the surgeon approaches the spine from the front of the neck, removes the damaged disc, relieves pressure on the nerves, and fuses the bones together. Another option is Posterior Cervical Fusion (PCF), which is done from the back of the neck. In some cases, both procedures are combined to provide more stability and support healing. The purpose of this study is to evaluate whether combining ACDF and PCF leads to better outcomes than ACDF alone in patients with two-level cervical degenerative disc disease.
Participants in this study will be assigned to one of two groups:
One group will receive ACDF alone (standard treatment) The other group will receive a combination of ACDF and PCF (investigational treatment) The main goal of the study is to compare how well the bones fuse together in each group at 12 months after surgery. The study will assess whether the combined approach (ACDF + PCF) results in a higher rate of successful fusion compared to ACDF alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Active comparator | Procedure: Anterior Cervical Discectomy and FusionAnterior Cervical Discectomy and Fusion (ACDF), which is a standard of care procedure |
| Circumferential Cervical Fusion (CCF) | Experimental | Device: Circumferential Cervical Fusion (CCF)Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circumferential Cervical Fusion (CCF)Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF) performed during the same surgical procedure, irrespective of order. The PCF procedure is performed using CORUS™ Spinal System-X to access and prepare the joint for fusion, followed by placement of PCSS 3D and delivery of an allograft demineralized bone matrix (DBM). | Device | Circumferential Cervical Fusion (CCF) |
| Anterior Cervical Discectomy and FusionACDF is performed using standard instruments and completed with a titanium interbody implant and anterior semi-constrained plate. The plate is intended to stabilize the treated levels until fusion occurs. | Procedure or surgery | Anterior Cervical Discectomy and Fusion (ACDF) |
Primary outcome
Superiority in Fusion Success in Treatment Arm (CCF) Compared to Control Arm (ACDF)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matt Jenkins study director
Providence Medical Technology, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumferential Cervical Fusion (CCF) and Anterior Cervical Discectomy and Fusion in people with Degenerative Disc Disease(DDD), run by Providence Medical Technology, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matt Jenkins (805-450-4965, mjenkins@providencemt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority in Fusion Success in Treatment Arm (CCF) Compared to Control Arm (ACDF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.