View Clinical Trial (Medical Research Study)

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

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Conditions:		Cervical Radiculopathy - Myelopathy
Purpose:		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.
Study Summary:
Criteria:		Inclusion Criteria: - Patient is skeletally mature - Patient has confirmed radiculopathy or myelopathy - Pain unresponsive to non-operative treatment - Radicular pain in either or both upper extremities - Neurological deficit in distribution of nerve root from C3/4 to C6/7 - Patient's lateral cervical spine x-rays show inferior aspect of lowest vertebral body to be fused - Patient agrees to comply with protocol - Patient can provide voluntary informed consent and follow-up information Exclusion Criteria: - Patient has previous cervical spine surgery - Patient requires concurrent posterior surgery at level to be treated, or anterior and posterior surgery at any other cervical level - Patient has clinically compromised vertebral body structure - Patient has multi-level fixed/ankylosed cervical spine - Patient has signs of significant instability at level to be treated or adjacent level - Patient has history of metabolic bone disease - Patient is taking chronic oral/IV corticosteroid therapy OR medications that potentially interfere with bone/soft tissue healing - Patient has progressive neuromuscular disease, rheumatoid arthritis, active malignancy, OR any other condition that interferes with self-assessment of pain, function, or quality of life - Patient has OPLL at any level - Patient has active infection, local or systemic - Patient is pregnant or considering pregnancy (x-ray requirements) - Patient is participating in another investigational study - Patient belongs to vulnerable population
NCT ID:		NCT00344890
Primary Contact:		Principal Investigator Bruce E. Mathern, M.D. VCU Medical Center Bruce E. Mathern, M.D. Phone: 804-828-9165 Email: bmathern@mcvh-vcu.edu
Backup Contact:		Email: rgraham@mcvh-vcu.edu Robert S. Graham, M.D. Phone: 804-828-9165
Location Contact:		Richmond, Virginia 23298 United States Bruce E Mathern, MD Phone: 804-828-9165 Email: bmathern@mcvh-vcu.edu Site Status: Recruiting

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