Clinical trial NCT04229017: Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Keywords: cervical spine
myelopathy
radiculopathy
cervical spine fusion
circumferential cervical fusion
degenerative disease
Lead sponsor: Providence Medical Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-14
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, controlled multi-center trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)
timeFrame: 12 months
Secondary outcomes:
measure: Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Encinitas
country: United States
facility: Scripps
state: California
city: Los Gatos
country: United States
facility: OrthoNorCal
state: California
city: Durango
country: United States
facility: Spine Colorado
state: Colorado
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Paducah
country: United States
facility: The Orthopaedic Institute
state: Kentucky
city: Baton Rouge
country: United States
facility: Bone and Joint Clinic of Baton Rouge
state: Louisiana
city: New Orleans
country: United States
facility: LSU Health
state: Louisiana
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: LifeBridge Health - Sinai Hospital of Baltimore
state: Maryland
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
city: Vineland
country: United States
facility: Inspira Health Network
state: New Jersey
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Surgical Clinic
state: North Carolina
city: Wilmington
country: United States
facility: Atlantic Neurosurgical & Spine Specialists
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Providence Medical Technology, Inc.
name: Matt Jenkins
role: STUDY_DIRECTOR
References: