Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD (FUSE)
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|ClinicalTrials.gov Identifier: NCT04229017|
Recruitment Status : Recruiting
First Posted : January 14, 2020
Last Update Posted : April 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease||Procedure: Anterior Cervical Discectomy and Fusion Device: Posterior Cervical Stabilization System (PCSS)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective, randomized, controlled multi-center trial|
|Masking Description:||Patients will be randomly assigned to either the treatment or control arms at 1:1 ratio.|
|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|
|Actual Study Start Date :||March 18, 2020|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||December 2023|
Active Comparator: Anterior Cervical Discectomy and Fusion (ACDF)
ACDF is a a standard of care procedure that is performed using standard instruments and completed with an allograft interbody implant and anterior plate. The plate is intended to stabilize the treated levels until fusion occurs.
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.
Other Name: ACDF
Experimental: Circumferential Cervical Fusion (CCF)
Circumferential Cervical Fusion (CCF) is a combination of ACDF and Posterior Cervical Fusion (PCF) procedures. The PCF is completed with Posterior Cervical Stabilization System (PCSS).
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.
- Superiority in Fusion Success in CCF (treatment) compared to ACDF (control) [ Time Frame: 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
- Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control) [ Time Frame: 24 months ]
An individual subject is considered a success if all of the following safety criteria are met:
- Fusion success - as defined by evidence of bridging trabecular bone across endplates and < 2° total angular motion
- Improvement in Neck Disability Index (NDI)
- Improvement in Neurological function
- Absence of secondary surgical interventions (SSI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229017
|Contact: Erik Summerside, Ph.D.||firstname.lastname@example.org|
|Contact: Victoria Sumnersemail@example.com|
|Study Director:||Victoria Sumners||Providence Medical Technology, Inc.|