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Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD (FUSE)

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ClinicalTrials.gov Identifier: NCT04229017
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Providence Medical Technology, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Procedure: Anterior Cervical Discectomy and Fusion Device: Posterior Cervical Stabilization System (PCSS) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, controlled multi-center trial
Masking: Single (Participant)
Masking Description: Patients will be randomly assigned to either the treatment or control arms at 1:1 ratio.
Primary Purpose: Treatment
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
Actual Study Start Date : March 18, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: Anterior Cervical Discectomy and Fusion
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 Name: ACDF
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).
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control) [ Time Frame: 24 months ]

    An individual subject is considered a success if all of the following safety criteria are met:

    1. Fusion success - as defined by evidence of bridging trabecular bone across endplates and < 2° total angular motion
    2. Improvement in Neck Disability Index (NDI)
    3. Improvement in Neurological function
    4. Absence of secondary surgical interventions (SSI)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-80 years (Skeletally Mature)
  2. Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 3 contiguous levels
  3. NDI Score of ≥15/50
  4. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
  5. Reported to be medically cleared for surgery
  6. 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.
  7. Written informed consent provided by subject

Exclusion Criteria:

  1. Body Mass Index (BMI) greater than 40 kg/m2
  2. Active systemic infection or infection at the operative site
  3. History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C
  4. Previous trauma to the C3 to C7 levels resulting in significant bony or disco- ligamentous cervical spine injury that may prevent device placements
  5. A prior spine surgery or pseudoarthrosis at the operative levels
  6. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention
  7. Symptomatic DDD or significant cervical spondylosis at more than three levels
  8. Diagnosis of spondylolisthesis, grade >2
  9. Overt (Segmental) instability measured as a movement on dynamic flex/ext x-rays >3.5 mm
  10. Congenital bony and/or spinal cord abnormalities that affect spinal stability
  11. Diagnosis of Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis
  12. Osteoporosis, defined as either the SCORE or MORES ≥ 6 and a DEXA bone density measured T-score of ≤ -2.5
  13. 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
  14. Has an uncontrolled seizure disorder
  15. Use of epidural steroids within 14 days prior to surgery
  16. A concomitant condition requiring daily, high-dose oral and/or inhaled steroids
  17. Known allergy to titanium (Ti).
  18. Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgical decompression
  19. Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders).
  20. Is pregnant or nursing at time of screening, or with plans to become pregnant within the next three years.
  21. A current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) that required treatment.
  22. Long term use (>6 months) of opioids (max. daily amount=120 mg morphine equivalents).
  23. 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.
  24. Any other condition or anatomy (e.g. fused facet) that makes posterior fusion treatment infeasible
  25. Use of any other investigational drug or medical device within the last 30 days prior to surgery.
  26. A pending personal litigation relating to spinal injury (worker's compensation is not exclusionary).
  27. Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229017


Contacts
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Contact: Erik Summerside, Ph.D. 920-227-5878 clinicalaffairs@providencemt.com
Contact: Victoria Sumners 678-357-2876 clinicalaffairs@providencemt.com

Locations
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United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Margaret Lambert       margaret.lambert@commonspirit.org   
United States, California
Scripps Recruiting
Encinitas, California, United States, 92024
Contact: Joy Biggers       biggers.joy@scrippshealth.org   
OrthoNorCal Recruiting
Los Gatos, California, United States, 95032
Contact: Janet Lamm       janet_lamm@elcaminohealth.org   
United States, Colorado
Spine Colorado Recruiting
Durango, Colorado, United States, 81301
Contact: Mariah Fuller-Pazell       mfullerpazell@spinecolorado.com   
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Martyna Stankute       Martyna_Stankute@rush.edu   
United States, Kentucky
The Orthopaedic Institute Recruiting
Paducah, Kentucky, United States, 42001
Contact: Becky Vinson    270-442-9461 ext 2142    rvinson@orthopaedicinstitute.com   
United States, Louisiana
LSU Health Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Brianne Voros       bvoros@lsuhsc.edu   
Spine Institute of Louisiana Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Marcus Stone, Ph.D.    318-629-5555    clinicalresearch@louisianaspine.org   
United States, Maryland
LifeBridge Health - Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Ashwin Mahajan, MD    410-601-9135    amahajan@lifebridgehealth.org   
United States, Michigan
Beaumont Health Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Vidya Nair       vidya.nair@beaumont.org   
United States, New Jersey
Inspira Health Network Recruiting
Vineland, New Jersey, United States, 08361
Contact: Cathy Vasquez    856-641-7921    vasquezc@ihn.org   
United States, North Carolina
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Jessica Ferrall    919-962-8852    jferrall@neurology.unc.edu   
Pinehurst Surgical Clinic Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Patricia Gause, LPN    910-334-1099    pwillingham@pinehurstsurgical.com   
Atlantic Neurosurgical & Spine Specialists Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Bridgette Smith       bridgette@atlanticneurosurgery.com;   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sara Thalheimer       Sara.Thalheimer@jefferson.edu   
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Rene Plascencia       rene.plascencia@bcm.edu   
Sponsors and Collaborators
Providence Medical Technology, Inc.
Investigators
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Study Director: Victoria Sumners Providence Medical Technology, Inc.
More Information
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Responsible Party: Providence Medical Technology, Inc.
ClinicalTrials.gov Identifier: NCT04229017    
Other Study ID Numbers: PMT0003
First Posted: January 14, 2020    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Providence Medical Technology, Inc.:
cervical spine
myelopathy
radiculopathy
 cervical spine fusion
circumferential cervical fusion
degenerative disease
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases