This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.
Medical Center Haaglanden
The Hague, Netherlands
Neck Disability Index
The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.
Time frame: 24 months post-op
Fusion Status
Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.
Time frame: 3 mo., 6mo., 12 mo., 24 months
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