Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Trea… (NCT04229017) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD
United States236 participantsStarted 2020-03-18
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
What they're measuring
1
Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)