Trial Information

Summary: CerviCore™ Intervertebral Disc Clinical Study

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):
  • 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).

  Participating sites are located in:

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Trial listings updated: June 1, 2008 at 5:45:39 AM