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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by LifeNet Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
LifeNet Health
ClinicalTrials.gov Identifier:
NCT00344890
First received: June 23, 2006
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
  • Rate of fusion [ Time Frame: 6 months post-op ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2006
Estimated Primary Completion Date: December 2012 (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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344890

Contacts
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

Locations
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   
Sponsors and Collaborators
LifeNet Health
Investigators
Principal Investigator: Bruce E. Mathern, M.D. VCU Medical Center
  More Information

No publications provided

Responsible Party: LifeNet Health
ClinicalTrials.gov Identifier: NCT00344890     History of Changes
Other Study ID Numbers: CR06-001, WIRB Protocol #20061453
Study First Received: June 23, 2006
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Radiculopathy
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 28, 2014