CerviCore™ Intervertebral Disc Clinical Study
(Sponsored clinical trial)

Introduction
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 annually thereafter, as feasible, through post-operative year 5.

Study sponsor
Stryker Spine, Summit, 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):
1. Pain unresponsive to non-operative treatment, AND/OR
2. 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:
1. 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,
2. 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:
   1. Chronic oral or IV corticosteroid therapy (this is not intended to exclude inhalation medications for asthma),
   2. Medications known to potentially interfere with bone/soft tissue healing (e.g. methotrexate),
   3. Medications which increase bone-mineral density (e.g. Fosamax^®, Didronel^®).
7. Diabetes mellitus requiring daily insulin management.
8. Has any of the following:
1. progressive neuromuscular disease;
2. rheumatoid arthritis;
3. 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);
4. active hepatitis;
5. AIDS, ARC, or is HIV positive;
6. 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);
7. syringomyelia at any spinal level;
8. 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).

Participating sites are located in:

San Diego, CA
Roseville, CA
San Francisco, CA
Overland Park, KS
Boston, MA
Springfield, MA
Southlake, TX
Lubbock, TX
Florence, SC
New York, NY
Southfield, MI
Oklahoma City, OK
Aventura, FL
Ft. Myers, FL
Palm Beach Gardens, FL
Clearwater, FL
Chicago, IL
Richmond, VA
Willow Grove, PA
Pittsburgh, PA
Seattle, WA
Indianapolis, IN
Scarborough, ME
St. Louis, MO

Call Center 1-888-830-PAIN (7246), or 800-334-3792.