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

This study has been completed.
Information provided by (Responsible Party):
LifeNet Health Identifier:
First received: June 23, 2006
Last updated: April 3, 2015
Last verified: April 2015

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
Cervical Radiculopathy Myelopathy Procedure: Anterior Cervical Discectomy and Fusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by LifeNet Health:

Primary Outcome Measures:
  • Degree of subsidence [ Time Frame: 3 months post-op ]
  • Rate of fusion [ Time Frame: 6 months post-op ]

Enrollment: 106
Study Start Date: September 2006
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preservon Procedure: Anterior Cervical Discectomy and Fusion
1,2,3,or 4 level surgery
Active Comparator: Control Procedure: Anterior Cervical Discectomy and Fusion
1,2,3,or 4 level surgery


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00344890

United States, Virginia
VCU Medical Center
Richmond, Virginia, United States, 23298-0631
Sponsors and Collaborators
LifeNet Health
Principal Investigator: Bruce E. Mathern, M.D. VCU Medical Center
  More Information

Responsible Party: LifeNet Health Identifier: NCT00344890     History of Changes
Other Study ID Numbers: CR06-001
WIRB Protocol #20061453
Study First Received: June 23, 2006
Last Updated: April 3, 2015

Keywords provided by LifeNet Health:
Cervical fusion
Anterior Cervical Discectomy and Fusion

Additional relevant MeSH terms:
Spinal Cord Diseases
Bone Marrow Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Central Nervous System Diseases
Hematologic Diseases processed this record on September 20, 2017