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Active, not recruiting Not applicable

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

NCT04229017 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2020-03-18
Last updated
2025-10-30

Condition(s) studied

Degenerative Disc Disease

Investigational drug(s) / intervention(s)

Anterior Cervical Discectomy and FusionPosterior Cervical Stabilization System (PCSS)

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Superiority in Fusion Success in CCF (treatment) compared to ACDF (control) — 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

Trial sites (17)

FacilityCityRegionStatus
Barrow Neurological Institute Phoenix Arizona
Scripps Encinitas California
OrthoNorCal Los Gatos California
Spine Colorado Durango Colorado
Rush University Medical Center Chicago Illinois
The Orthopaedic Institute Paducah Kentucky
Bone and Joint Clinic of Baton Rouge Baton Rouge Louisiana
LSU Health New Orleans Louisiana
Spine Institute of Louisiana Shreveport Louisiana
LifeBridge Health - Sinai Hospital of Baltimore Baltimore Maryland
Beaumont Health Royal Oak Michigan
Inspira Health Network Vineland New Jersey
The University of North Carolina at Chapel Hill Chapel Hill North Carolina
Pinehurst Surgical Clinic Pinehurst North Carolina
Atlantic Neurosurgical & Spine Specialists Wilmington North Carolina
Thomas Jefferson University Philadelphia Pennsylvania
Baylor College of Medicine Houston Texas
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04229017 on ClinicalTrials.gov ↗ ← All trials in the USA