Status:
COMPLETED
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
Lead Sponsor:
LifeNet Health
Conditions:
Cervical Radiculopathy
Myelopathy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 cer...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00344890
Start Date
September 1 2006
End Date
December 1 2012
Last Update
April 7 2015
Active Locations (1)
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1
VCU Medical Center
Richmond, Virginia, United States, 23298-0631