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

Primary Purpose

Degenerative Disc Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anterior Cervical Discectomy and Fusion
Posterior Cervical Stabilization System (PCSS)
Sponsored by
Providence Medical Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring cervical spine, myelopathy, radiculopathy, cervical spine fusion, circumferential cervical fusion, degenerative disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barrow Neurological Institute
  • Scripps
  • OrthoNorCal
  • Spine Colorado
  • Rush University Medical Center
  • The Orthopaedic Institute
  • Bone and Joint Clinic of Baton Rouge
  • LSU Health
  • Spine Institute of Louisiana
  • LifeBridge Health - Sinai Hospital of Baltimore
  • Beaumont Health
  • Inspira Health Network
  • The University of North Carolina at Chapel Hill
  • Pinehurst Surgical Clinic
  • Atlantic Neurosurgical & Spine Specialists
  • Thomas Jefferson University
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Anterior Cervical Discectomy and Fusion (ACDF)

Circumferential Cervical Fusion (CCF)

Arm Description

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) is a combination of ACDF and Posterior Cervical Fusion (PCF) procedures. The PCF is completed with Posterior Cervical Stabilization System (PCSS).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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: 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)

Full Information

First Posted
December 23, 2019
Last Updated
May 4, 2023
Sponsor
Providence Medical Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04229017
Brief Title
Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD
Acronym
FUSE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 18, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Medical Technology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
cervical spine, myelopathy, radiculopathy, cervical spine fusion, circumferential cervical fusion, degenerative disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, controlled multi-center trial
Masking
Participant
Masking Description
Patients will be randomly assigned to either the treatment or control arms at 1:1 ratio.
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anterior Cervical Discectomy and Fusion (ACDF)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Circumferential Cervical Fusion (CCF)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Anterior Cervical Discectomy and Fusion
Other Intervention Name(s)
ACDF
Intervention Description
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
Device
Intervention Name(s)
Posterior Cervical Stabilization System (PCSS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Superiority in Fusion Success in CCF (treatment) compared to ACDF (control)
Description
An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across endplates and < 2° total angular motion
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Non-inferiority Composite Safety Success in CCF (treatment) compared to ACDF (control)
Description
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)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 A concomitant condition requiring daily, high-dose oral and/or inhaled steroids Known allergy to titanium (Ti). Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgical decompression Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders). Is pregnant or nursing at time of screening, or with plans to become pregnant within the next three years. A current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) that required treatment. Long term use (>6 months) of opioids (max. daily amount=120 mg morphine equivalents). 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. Any other condition or anatomy (e.g. fused facet) that makes posterior fusion treatment infeasible Use of any other investigational drug or medical device within the last 30 days prior to surgery. A pending personal litigation relating to spinal injury (worker's compensation is not exclusionary). Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Jenkins
Organizational Affiliation
Providence Medical Technology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Scripps
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
OrthoNorCal
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Spine Colorado
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The Orthopaedic Institute
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Bone and Joint Clinic of Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
LSU Health
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
LifeBridge Health - Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Beaumont Health
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Inspira Health Network
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08361
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Pinehurst Surgical Clinic
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Atlantic Neurosurgical & Spine Specialists
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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