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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Active Comparator | 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. |
|
| Circumferential Cervical Fusion (CCF) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Cervical Discectomy and Fusion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority in Fusion Success in CCF (treatment) compared to ACDF (control) | An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across endplates and < 2° total angular motion | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control) | An individual subject is considered a success if all of the following safety criteria are met:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matt Jenkins | Providence Medical Technology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Scripps |
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prospective, randomized, controlled multi-center trial
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Patients will be randomly assigned to either the treatment or control arms at 1:1 ratio.
|
| Posterior Cervical Stabilization System (PCSS) | Device | 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. |
|
| 24 months |
| Encinitas |
| California |
| 92024 |
| United States |
| OrthoNorCal | Los Gatos | California | 95032 | United States |
| Spine Colorado | Durango | Colorado | 81301 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| The Orthopaedic Institute | Paducah | Kentucky | 42001 | United States |
| Bone and Joint Clinic of Baton Rouge | Baton Rouge | Louisiana | 70808 | United States |
| LSU Health | New Orleans | Louisiana | 70112 | United States |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | United States |
| LifeBridge Health - Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Beaumont Health | Royal Oak | Michigan | 48073 | United States |
| Inspira Health Network | Vineland | New Jersey | 08361 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Pinehurst Surgical Clinic | Pinehurst | North Carolina | 28374 | United States |
| Atlantic Neurosurgical & Spine Specialists | Wilmington | North Carolina | 28401 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2026 | May 28, 2026 | 23 |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013118 | Spinal Cord Diseases |
| D011843 | Radiculopathy |
| D007714 | Klippel-Feil Syndrome |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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