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

Sponsor

Providence Medical Technology, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04229017

Collaborator

(none)

330

Enrollment

Locations

Arms

44.5

Anticipated Duration (Months)

19.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease	Procedure: Anterior Cervical Discectomy and Fusion Device: Posterior Cervical Stabilization System (PCSS)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

330 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, randomized, controlled multi-center trialprospective, randomized, controlled multi-center trial

Masking:

Single (Participant)

Masking Description:

Patients will be randomly assigned to either the treatment or control arms at 1:1 ratio.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 18, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: 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. Other Names: ACDF
Experimental: 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).	Device: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: 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.

Other Names:

ACDF

Experimental: 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).

Device: 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.

Outcome Measures

Primary Outcome Measures

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

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: 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barrow Neurological Institute	Phoenix	Arizona	United States	85013
2	Scripps	Encinitas	California	United States	92024
3	OrthoNorCal	Los Gatos	California	United States	95032
4	Spine Colorado	Durango	Colorado	United States	81301
5	Rush University Medical Center	Chicago	Illinois	United States	60612
6	The Orthopaedic Institute	Paducah	Kentucky	United States	42001
7	Bone and Joint Clinic of Baton Rouge	Baton Rouge	Louisiana	United States	70808
8	LSU Health	New Orleans	Louisiana	United States	70112
9	Spine Institute of Louisiana	Shreveport	Louisiana	United States	71101
10	LifeBridge Health - Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21215
11	Beaumont Health	Royal Oak	Michigan	United States	48073
12	Inspira Health Network	Vineland	New Jersey	United States	08361
13	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
14	Pinehurst Surgical Clinic	Pinehurst	North Carolina	United States	28374
15	Atlantic Neurosurgical & Spine Specialists	Wilmington	North Carolina	United States	28401
16	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
17	Baylor College of Medicine	Houston	Texas	United States	77030