Discover™ Artificial Cervical Disc FDA Clinical Trial

Dr. Harold Hess was chosen to be one of 25 investigators in the U.S. for the Depuy Spine (a Johnson & Johnson company) Discover™ artificial cervical disc FDA clinical trial.

Contact us for More Information on the Artificial Cervical Disc

Purpose

Since the early 1950’s, surgeons believed that anterior cervical discectomy and fusion (ACDF) prevents progressive spondylotic spurring, and it works to stabilize the motion segment thereby leading to spur regression. ACDF enables indirect decompression by distraction of the disc space, and it minimizes the need for surgical manipulation of the spinal cord. However, ACDF is associated with adjacent level disease, and mobility is progressively decreased with each level that is fused. This multi-center, prospective, randomized controlled trial is designed to evaluate the safety and effectiveness of the DISCOVER™ Artificial Cervical Disc when compared to ACDF for the treatment of cervical Degenerative Disc Disease. This study will also explore potential advantages of the DISCOVER™ Artificial Cervical Disc over ACDF.

Requirements

The study period for each subject will be a minimum of 60 months. The anticipated enrollment for this study is 12 months. The resultant study follow-up to completion is 60 months. A sample size of 790 subjects at 30 investigative sites in North America combined in the 1-level and 2-level applications will be accrued. The next nearest site in the study is in Texas.

1. Five Year Follow-up
2. Multiple x-ray studies
3. Four Axial CT scans
4. Patient agrees to randomization. Study will be in a 2:1 ratio, stratified separately within 1- and 2-level applications, favoring the artificial disc.
5. Follow-up appointments at 2 and 6 weeks, 3, 6, 12, 24, 36, 48, and 60 months

Inclusion Criteria

1. Patient 21 to 70 years of age
2. Cervical disc disease in 1 or 2 adjacent vertebral levels between C3-C7 defined as:
1. upper extremity radicular pain
2. subjects with myelo-radiculopathy
3. Failed non-surgical treatment of at least 6 weeks, or subject has progressive symptoms of nerve root or spinal cord compression
4. Minimum neck disability index score of ≥30% (15/50)
5. Must understand and sign ethics committee / institutional review board approved informed consent form
6. Able to meet follow-up schedule requirements and post-operative management program
7. If required, bone mineral density T-score of ≥ –1.5 SD as confirmed by DEXA

Exclusion Criteria

1. Degeneration at more than two cervical levels
2. Prior surgery at target levels (prior fusions C1-T1)
3. Cervical instability
4. Requires medications that interfere with bone /soft tissue healing
5. Metabolic bone disease or endocrine disorder affecting osteogenesis
6. Pregnant or wishing to become pregnant within 5 years
7. Alcohol or drug abuse
8. Pre-existing neurological abnormalities other then deficits produced from the spinal lesion
9. Involved in litigations or seeking permanent disability status
10. Inmate, HIV, metastatic cancer, presence of infection, morbid obesity, significant psychological disease, or allergy to a metal alloy or polyethylene

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