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

NCT ID: NCT04229017

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-18
• Study Completion Date: 2025-12-31

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.

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Anterior Cervical Discectomy and Fusion

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Posterior Cervical Stabilization System (PCSS)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Other Intervention Names

ACDF

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Medical Technology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matt Jenkins

Role: STUDY_DIRECTOR

Providence Medical Technology, Inc.

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Scripps

Encinitas, California, United States

OrthoNorCal

Los Gatos, California, United States

Spine Colorado

Durango, Colorado, United States

Rush University Medical Center

Chicago, Illinois, United States

The Orthopaedic Institute

Paducah, Kentucky, United States

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, United States

LSU Health

New Orleans, Louisiana, United States

Spine Institute of Louisiana

Shreveport, Louisiana, United States

LifeBridge Health - Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Beaumont Health

Royal Oak, Michigan, United States

Inspira Health Network

Vineland, New Jersey, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Pinehurst Surgical Clinic

Pinehurst, North Carolina, United States

Atlantic Neurosurgical & Spine Specialists

Wilmington, North Carolina, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

PMT0003

Identifier Type: -

Identifier Source: org_study_id