CERVICORE™ INTERVERTEBRAL DISC

CerviCore™ Intervertebral Disc Clinical Study

Status: This trial has been completed.

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 for 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

Inclusion criteria (key criteria):

  • Skeletally mature and between 18 and 65 years of age, inclusively
  • 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
  • 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):

  • Axial neck pain or referred shoulder pain alone (without radicular symptoms)
  • Radicular symptoms in the distribution of more than one cervical nerve root/disc
  • 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)
  • History of metabolic bone disease
  • Post-menopausal woman with a DEXA scan hip t-score of < -2.5
  • 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®)
  • Diabetes mellitus requiring daily insulin management
  • 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
  • Pregnant or is considering pregnancy within the next 3 years (excluded due to x-ray requirements)

Caution: Investigational device limited by United State law to investigational use. If you think you might be a candidate for this clinical trial, contact us for more information or fill out and submit our online forms.


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