Degenerative Disc DiseaseFUSENCT04229017
Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD
A study testing Anterior Cervical Discectomy and Fusion and Posterior Cervical Stabilization System (PCSS) in people with Degenerative Disc Disease, run by Providence Medical Technology, Inc. at 17 sites in United States.
Trial summary
This study will evaluate the safety and effectiveness of a device called "Posterior Cervical Stabilization System or PCSS" when used along with posterior cervical fusion (PCF) in combination with anterior cervical discectomy and fusion (ACDF) in the treatment of multi-level cervical degenerative disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Anterior Cervical Discectomy and Fusion and Posterior Cervical Stabilization System (PCSS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 17 sitesUnited States
- Study dates
- 18 Mar 2020to Dec 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years (Skeletally Mature)
- Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 3 contiguous levels
- NDI Score of ≥15/50
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
- 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
- Body Mass Index (BMI) greater than 40 kg/m2
- 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 placements
- 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
Show all 27Show fewer
- Symptomatic DDD or significant cervical spondylosis at more than three levels
- Diagnosis of spondylolisthesis, grade >2
- Overt (Segmental) instability measured as a movement on dynamic flex/ext 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 osteoporosis
- 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
- 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 within the next three years.
- 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.
- A 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
17 sites in 1 country.
17 sites in 1 country
United States17 sites
LifeBridge Health - Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, 70808
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Rush University Medical Center
Chicago, Illinois, 60612
Spine Colorado
Durango, Colorado, 81301
Scripps
Encinitas, California, 92024
Baylor College of Medicine
Houston, Texas, 77030
OrthoNorCal
Los Gatos, California, 95032
LSU Health
New Orleans, Louisiana, 70112
The Orthopaedic Institute
Paducah, Kentucky, 42001
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
Beaumont Health
Royal Oak, Michigan, 48073
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Inspira Health Network
Vineland, New Jersey, 08361
Atlantic Neurosurgical & Spine Specialists
Wilmington, North Carolina, 28401
About this study
Official title: Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an Adjunct to Posterior Cervical Fusion, When Used in Combination With ACDF in Treatment of Multi-level Cervical Degenerative Disease
This study will evaluate the safety and effectiveness of a device called "Posterior Cervical Stabilization System or PCSS" when used along with posterior cervical fusion (PCF) in combination with anterior cervical discectomy and fusion (ACDF) in the treatment of multi-level cervical degenerative disease.
Read the detailed description
Degenerative disc disease (DDD) is a condition in which people experience pain because of compression on the spinal cord or nerve roots caused by degenerating cervical discs. Discs sit between the bones of the spine to provide cushioning, shock absorption, mobility, and load-bearing. When the discs break down, the space between the bones gets smaller and squeezes on the spinal cord or nerve roots causing radiating pain down the neck, shoulders, or arms.
A surgical approach to address cervical (neck) DDD is to fuse the bones together to prevent further compression. This can be done with or without removing the disc material itself. The most common way to perform a cervical spinal (neck) fusion to address DDD is to come in from the front of the neck, decompress the spine to relieve pain, and fuse the bones together to prevent further pain in a procedure called Anterior Cervical Discectomy and Fusion (ACDF). Another option is to come in from the back of the neck in a procedure called Posterior Cervical Fusion (PCF). Sometimes these procedures are combined to provide further decompression and stability in the bones of the neck to promote fusion leading to quicker pain relief and return to function.
- Conditions
- Degenerative Disc Disease
- Being tested
- Anterior Cervical Discectomy and Fusion, Posterior Cervical Stabilization System (PCSS)
- Keywords
- cervical spine, myelopathy, radiculopathy, cervical spine fusion, circumferential cervical fusion, degenerative disease
- 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.
Anterior Cervical Discectomy and FusionProcedure or surgery
Also called ACDF
Anterior Cervical Decompression and Fusion (ACDF) is a standard of care procedure that is performed using standard instruments and completed with an allograft interbody implant and anterior plate.
Posterior Cervical Stabilization System (PCSS)Device
Posterior Cervical Stabilization System (PCSS) is non-segmental instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. PCSS achieves bilateral facet fixation by spanning the interspace at each level with points of fixation at each end of the construct.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Active comparator | ACDF is a a standard of care procedure that is performed using standard instruments and completed with an allograft interbody implant and anterior plate. The plate is intended to stabilize the treated levels until fusion occurs. Receives: Procedure: Anterior Cervical Discectomy and Fusion |
| Circumferential Cervical Fusion (CCF) | Experimental | Circumferential Cervical Fusion (CCF) is a combination of ACDF and Posterior Cervical Fusion (PCF) procedures. The PCF is completed with Posterior Cervical Stabilization System (PCSS). Receives: Device: Posterior Cervical Stabilization System (PCSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)
An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across endplates and < 2° total angular motion
Measured: 12 months
Secondary outcomes (1)
Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)
An individual subject is considered a success if all of the following safety criteria are met:
- Fusion success - as defined by evidence of bridging trabecular bone across endplates and < 2° total angular motion
- Improvement in Neck Disability Index (NDI)
- Improvement in Neurological function
- Absence of secondary surgical interventions (SSI)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start18 Mar 2020
- Primary completion22 Jul 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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 multi-center trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 236 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
- NCT04229017
- Sponsor's protocol ID
- PMT0003
- Acronym
- FUSE
- Status last verified
- Nov 2024
- First submitted
- 23 Dec 2019
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an Adjunct to Posterior Cervical Fusion, When Used in Combination With ACDF in Treatment of Multi-level Cervical Degenerative Disease
- ClinicalTrials.gov ID
- NCT04229017
- Acronym / sponsor ID
- FUSE / PMT0003
- Conditions
- Degenerative Disc Disease
- Keywords
- cervical spine, myelopathy, radiculopathy, cervical spine fusion, circumferential cervical fusion, degenerative disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Providence Medical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Jan 2020 (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.
This study will evaluate the safety and effectiveness of a device called "Posterior Cervical Stabilization System or PCSS" when used along with posterior cervical fusion (PCF) in combination with anterior cervical discectomy and fusion (ACDF) in the treatment of multi-level cervical degenerative disease.
Detailed description
Degenerative disc disease (DDD) is a condition in which people experience pain because of compression on the spinal cord or nerve roots caused by degenerating cervical discs. Discs sit between the bones of the spine to provide cushioning, shock absorption, mobility, and load-bearing. When the discs break down, the space between the bones gets smaller and squeezes on the spinal cord or nerve roots causing radiating pain down the neck, shoulders, or arms.
A surgical approach to address cervical (neck) DDD is to fuse the bones together to prevent further compression. This can be done with or without removing the disc material itself. The most common way to perform a cervical spinal (neck) fusion to address DDD is to come in from the front of the neck, decompress the spine to relieve pain, and fuse the bones together to prevent further pain in a procedure called Anterior Cervical Discectomy and Fusion (ACDF). Another option is to come in from the back of the neck in a procedure called Posterior Cervical Fusion (PCF). Sometimes these procedures are combined to provide further decompression and stability in the bones of the neck to promote fusion leading to quicker pain relief and return to function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled multi-center trial
| Arm | Type | Receives |
|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Active comparator | Procedure: Anterior Cervical Discectomy and FusionACDF is a a standard of care procedure that is performed using standard instruments and completed with an allograft interbody implant and anterior plate. The plate is intended to stabilize the treated levels until fusion occurs. |
| Circumferential Cervical Fusion (CCF) | Experimental | Device: Posterior Cervical Stabilization System (PCSS)Circumferential Cervical Fusion (CCF) is a combination of ACDF and Posterior Cervical Fusion (PCF) procedures. The PCF is completed with Posterior Cervical Stabilization System (PCSS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years (Skeletally Mature)
- Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 3 contiguous levels
- NDI Score of ≥15/50
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
- Reported to be medically cleared for surgery
Key exclusion criteria (27 listed)
- Body Mass Index (BMI) greater than 40 kg/m2
- 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 placements
- 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 |
|---|---|---|
| Anterior Cervical Discectomy and FusionAlso: ACDFAnterior Cervical Decompression and Fusion (ACDF) is a standard of care procedure that is performed using standard instruments and completed with an allograft interbody implant and anterior plate. | Procedure or surgery | Anterior Cervical Discectomy and Fusion (ACDF) |
| Posterior Cervical Stabilization System (PCSS)Posterior Cervical Stabilization System (PCSS) is non-segmental instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. PCSS achieves bilateral facet fixation by spanning the interspace at each level with points of fixation at each end of the construct. | Device | Circumferential Cervical Fusion (CCF) |
Primary outcome
Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)
Time frame: 12 months
An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across endplates and < 2° total angular motion
1 secondary outcome
Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)
Time frame: 24 months
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 30 Oct 2025.
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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. This study is not recruiting at the moment.
Matt Jenkins study director
Providence Medical Technology, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Cervical Discectomy and Fusion and Posterior Cervical Stabilization System (PCSS) in people with Degenerative Disc Disease, run by Providence Medical Technology, Inc. at 17 sites 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 7 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority in Fusion Success in CCF (treatment) compared to ACDF (control) (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 30 Oct 2025.