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

Not Applicable

Active, not recruiting

• Conditions: Degenerative Disc Disease
• Interventions: Procedure: Anterior Cervical Discectomy and Fusion; Device: Posterior Cervical Stabilization System (PCSS)

• Registration Number: NCT04229017
• Lead Sponsor: Providence Medical Technology, Inc.

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.

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-14
• Study Start: 2020-03-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 236

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterior Cervical Discectomy and Fusion (ACDF)	Anterior Cervical Discectomy and Fusion	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)	Posterior Cervical Stabilization System (PCSS)	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).

Primary Outcome Measures

Name	Time	Method
Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)	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

Secondary Outcome Measures

Name	Time	Method
Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)	24 months	An individual subject is considered a success if all of the following safety criteria are met: 1. Fusion success - as defined by evidence of bridging trabecular bone across endplates and \< 2° total angular motion; 2. Improvement in Neck Disability Index (NDI); 3. Improvement in Neurological function; 4. Absence of secondary surgical interventions (SSI)

Trial Locations

Locations (17)

LifeBridge Health - Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Scripps; 🇺🇸 Encinitas, California, United States

OrthoNorCal; 🇺🇸 Los Gatos, California, United States

Beaumont Health; 🇺🇸 Royal Oak, Michigan, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

The Orthopaedic Institute; 🇺🇸 Paducah, Kentucky, United States

Spine Colorado; 🇺🇸 Durango, Colorado, United States

Bone and Joint Clinic of Baton Rouge; 🇺🇸 Baton Rouge, Louisiana, United States

Spine Institute of Louisiana; 🇺🇸 Shreveport, Louisiana, United States

Inspira Health Network; 🇺🇸 Vineland, New Jersey, United States

Atlantic Neurosurgical & Spine Specialists; 🇺🇸 Wilmington, North Carolina, United States

Pinehurst Surgical Clinic; 🇺🇸 Pinehurst, North Carolina, United States

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

LSU Health; 🇺🇸 New Orleans, Louisiana, United States

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States