- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04229017
Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD (FUSE)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Erik Summerside, Ph.D.
- Phone Number: 920-227-5878
- Email: clinicalaffairs@providencemt.com
Study Contact Backup
- Name: Stacey Underwood
- Phone Number: 520-262-3704
- Email: clinicalaffairs@providencemt.com
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85013
- Barrow Neurological Institute
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California
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Encinitas, California, United States, 92024
- Scripps
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Los Gatos, California, United States, 95032
- OrthoNorcal
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Colorado
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Durango, Colorado, United States, 81301
- Spine Colorado
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Kentucky
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Paducah, Kentucky, United States, 42001
- The Orthopaedic Institute
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Bone and Joint Clinic of Baton Rouge
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New Orleans, Louisiana, United States, 70112
- LSU Health
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Shreveport, Louisiana, United States, 71101
- Spine Institute of Louisiana
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Maryland
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Baltimore, Maryland, United States, 21215
- LifeBridge Health - Sinai Hospital of Baltimore
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Michigan
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Royal Oak, Michigan, United States, 48073
- Beaumont Health
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New Jersey
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Vineland, New Jersey, United States, 08361
- Inspira Health Network
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- The University of North Carolina at Chapel Hill
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Pinehurst, North Carolina, United States, 28374
- Pinehurst Surgical Clinic
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Wilmington, North Carolina, United States, 28401
- Atlantic Neurosurgical & Spine Specialists
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Anterior Cervical Discectomy and Fusion (ACDF)
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.
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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.
Other Names:
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Experimental: Circumferential Cervical Fusion (CCF)
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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)
Time Frame: 12 months
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An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across endplates and < 2° total angular motion
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)
Time Frame: 24 months
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An individual subject is considered a success if all of the following safety criteria are met:
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24 months
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Collaborators and Investigators
Investigators
- Study Director: Matt Jenkins, Providence Medical Technology, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMT0003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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