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 that 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
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