CerviCore™ Intervertebral Disc Clinical Study

Introduction

This study is exclusively provided by the Neurosurgeons of Tri-State Neurosurgical Associates-UPMC
 

The study is a multi-center, prospective, randomized controlled clinical trial that will compare the safety and effectiveness of the CerviCore™ Intervertebral Disc to anterior cervical discectomy and fusion (ACDF) with a rigid plate in the treatment of radicular symptoms associated with loss of disc height, disc/osteophyte complex, or herniated disc at a single cervical spine level.

The trade name of the investigational device is: CerviCore™ Intervertebral Disc.

Study objectives
The objective of this clinical investigation is to compare the safety and effectiveness of the CerviCore™ to ACDF surgery in the treatment of cervical radicular symptoms (upper extremity pain and/or neurological deficit) associated with loss of disc height, disc/osteophyte complex, or herniated disc at a single level between C3 and C7.

Study overview
Up to twenty-five (25) study centers will participate.

Approximately four hundred (400) patients will enroll in the study.

Patients will be randomized to receive either the CerviCore™ Intervertebral Disc or the control treatment (ACDF).

Study patients will be followed at 6 weeks, 3 months, 6 months, 12 months 24 months and annually thereafter, as feasible, through post-operative year 5.

Study sponsor
Stryker Spine, Allendale, NJ

Status
Recruiting

Inclusion criteria (key criteria):

1.       Skeletally mature and between 18 and 65 years of age, inclusively

2.       Clinically confirmed radicular symptoms in the distribution of a single degenerated disc from C3/4 to C6/7 in either or both of the upper extremities defined by the following complaint(s):
a. Pain unresponsive to non-operative treatment, AND/OR
b. Neurological deficit

3.       Radicular symptoms are consistent with radiographic evidence of single level nerve root compression (from C3/4 to C6/7) associated with at least one of the following:
a. significant loss of disc height as judged by the Investigator on MRI and/or CT as compared to the normal and clinically asymptomatic adjacent levels,
b. posterior osteophytes or disc/osteophyte complex or posterior soft disc herniation

Exclusion criteria (key criteria):

1.       Axial neck pain or referred shoulder pain alone (without radicular symptoms)

2.       Radicular symptoms in the distribution of more than one cervical nerve root/disc

3.       Previous cervical surgery including: any discectomy, any anterior cervical fusion, or any posterior cervical fusion or instrumentation. (This is not intended to exclude a patient with a prior laminectomy/laminotomy at a level that is not the target or adjacent level)

4.       History of metabolic bone disease

5.       Post-menopausal woman with a DEXA scan hip t-score of < -2.5

6.       Taking any of the following medications:
a. Chronic oral or IV corticosteroid therapy (this is not intended to exclude inhalation medications for asthma),
b. Medications known to potentially interfere with bone/soft tissue healing (e.g. methotrexate),
c. Medications which increase bone-mineral density (e.g. Fosamax®, Didronel®)

7.       Diabetes mellitus requiring daily insulin management

8.       Has any of the following:
a. progressive neuromuscular disease;
b. rheumatoid arthritis;
c. active malignancy within the last 15 years (unless the malignancy was treated with curative intent and there have been no clinical signs or symptoms for at least 5 years);
d. active hepatitis;
e. AIDS, ARC, or is HIV positive;
f. cervical myelopathy at any cervical level (This is not intended to exclude cervical myelopathy at the level to be treated due to a soft disc herniation within the past 12 months that can be decompressed by an anterior discectomy);
g. syringomyelia at any spinal level;
h. any condition that would interfere with patient self-assessment of pain, function or quality of life

9.       Pregnant or is considering pregnancy within the next 3 years (excluded due to x-ray requirements)

 Phone: 1-888-234-4357 for more information and how to be evaluated for this study

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