NCT04229017

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Providence Medical Technology, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-03-18
• Primary completion: 2024-07-22
• Completion: 2025-12-01
• First posted: 2020-01-14
• Last updated: 2025-10-30

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study