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Sponsored by: |
LifeNet Health |
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Information provided by: | LifeNet Health |
ClinicalTrials.gov Identifier: | NCT00344890 |
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.
Condition | Intervention |
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Cervical Radiculopathy Myelopathy |
Procedure: Anterior Cervical Discectomy and Fusion |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Preservon: Experimental |
Procedure: Anterior Cervical Discectomy and Fusion
1,2,3,or 4 level surgery
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Control: Active Comparator |
Procedure: Anterior Cervical Discectomy and Fusion
1,2,3,or 4 level surgery
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bruce E. Mathern, M.D. | 804-828-9165 | bmathern@mcvh-vcu.edu |
Contact: Robert S. Graham, M.D. | 804-828-9165 | rgraham@mcvh-vcu.edu |
United States, Virginia | |
VCU Medical Center | Recruiting |
Richmond, Virginia, United States, 23298-0631 | |
Contact: Bruce E Mathern, MD 804-828-9165 bmathern@mcvh-vcu.edu |
Principal Investigator: | Bruce E. Mathern, M.D. | VCU Medical Center |
Responsible Party: | LifeNet Health ( Dr. Mark Moore ) |
Study ID Numbers: | CR06-001, WIRB Protocol #20061453 |
Study First Received: | June 23, 2006 |
Last Updated: | January 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00344890 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cervical fusion Anterior Cervical Discectomy and Fusion ACDF |
Neuromuscular Diseases Spinal Cord Diseases Peripheral Nervous System Diseases Radiculopathy Central Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Peripheral Nervous System Diseases |
Nervous System Diseases Radiculopathy Central Nervous System Diseases |