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

Running, not enrolling · Not applicable

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT04229017

Run by

Providence Medical Technology, Inc.

People needed

236

Starts

2020-03-18

Expected to finish

2025-12-01

Last updated by the study team

2025-10-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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