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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00344890
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
LifeNet Health

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 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 or disease Intervention/treatment Phase
Cervical Radiculopathy Myelopathy Procedure: Anterior Cervical Discectomy and Fusion Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: LifeNet Health Identifier: NCT00344890     History of Changes
Other Study ID Numbers: CR06-001
WIRB Protocol #20061453
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 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