Cervical Radiculopathy Clinical Trial
Official title:
A Safety and Efficacy Comparison of Preservon Treated Allograft Bone Dowels Versus Traditional Freeze-Dried Allograft Bone Dowels for Fusion of Degenerated Cervical Intervertebral Discs in the Treatment of Cervical Radiculopathy or Myelopathy
The purpose of this study is to compare the safety and efficacy of Preservon(TM) treated
allograft bone dowels to traditional freeze-dried allograft bone dowels (control) for fusion
of degenerated cervical intervertebral discs in the treatment of cervical radiculopathy or
myelopathy.
Patient follow-up will be conducted at 6 weeks, 3 months, and 6 months. At 3 months after
surgery, the implanted bone dowels will be assessed for subsidence; at 6 months after
surgery, the implanted bone dowels will be assessed for fusion. Patients will complete
questionnaires and x-rays taken at each visit.
The degree of subsidence and rate of fusion will be assessed based on the evaluation of the
x-rays taken. The x-ray evaluation will be conducted by a neurosurgeon who is blinded to the
type of treatment that each patient has received.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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