Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cervical Radiculopathy, Myelopathy

Intervention / Treatment
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* Procedure: Anterior Cervical Discectomy and Fusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preservon<br> | Procedure: Anterior Cervical Discectomy and Fusion<br>* 1,2,3,or 4 level surgery<br>|
| Active Comparator: Control<br> | Procedure: Anterior Cervical Discectomy and Fusion<br>* 1,2,3,or 4 level surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of subsidence |  | 3 months post-op | 
| Rate of fusion |  | 6 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACDF, Cervical fusion, Anterior Cervical Discectomy and Fusion