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

NCT04229017 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PMT0003
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 17

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.

Conditions

Degenerative Disc Disease

Keywords

cervical spine; myelopathy; radiculopathy; cervical spine fusion; circumferential cervical fusion; degenerative disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)

  24 months

Study Arms (2)

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.

Procedure: Anterior Cervical Discectomy and Fusion

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).

Device: Posterior Cervical Stabilization System (PCSS)

Interventions

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.

Also known as: ACDF

Anterior Cervical Discectomy and Fusion (ACDF)

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.

Circumferential Cervical Fusion (CCF)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years (Skeletally Mature)
• Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 3 contiguous levels
• NDI Score of ≥15/50
• Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
• Reported to be medically cleared for surgery
• 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.
• Written informed consent provided by subject

You may not qualify if:

• Body Mass Index (BMI) greater than 40 kg/m2
• Active systemic infection or infection at the operative site
• History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C
• Previous trauma to the C3 to C7 levels resulting in significant bony or disco- ligamentous cervical spine injury that may prevent device placements
• A prior spine surgery or pseudoarthrosis at the operative levels
• Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention
• Symptomatic DDD or significant cervical spondylosis at more than three levels
• Diagnosis of spondylolisthesis, grade \>2
• Overt (Segmental) instability measured as a movement on dynamic flex/ext x-rays \>3.5 mm
• Congenital bony and/or spinal cord abnormalities that affect spinal stability
• Diagnosis of Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis
• Osteoporosis, defined as either the SCORE or MORES ≥ 6 and a DEXA bone density measured T-score of ≤ -2.5
• 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
• Has an uncontrolled seizure disorder
• Use of epidural steroids within 14 days prior to surgery

Sponsors & Collaborators

• Providence Medical Technology, Inc.: lead

Study Sites (17)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Scripps

Encinitas, California, 92024, United States

Location

OrthoNorCal

Los Gatos, California, 95032, United States

Location

Spine Colorado

Durango, Colorado, 81301, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

The Orthopaedic Institute

Paducah, Kentucky, 42001, United States

Location

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, 70808, United States

Location

LSU Health

New Orleans, Louisiana, 70112, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

LifeBridge Health - Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

Inspira Health Network

Vineland, New Jersey, 08361, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Atlantic Neurosurgical & Spine Specialists

Wilmington, North Carolina, 28401, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Cord Diseases; Radiculopathy; Klippel-Feil Syndrome

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Dysostoses; Bone Diseases, Developmental; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Officials

• Matt Jenkins

  Providence Medical Technology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomly assigned to either the treatment or control arms at 1:1 ratio.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, randomized, controlled multi-center trial

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 14, 2020
• Study Start: March 18, 2020
• Primary Completion: July 22, 2024
• Study Completion: December 1, 2025
• Last Updated: October 30, 2025

Record last verified: 2024-11

Locations

US (17)