- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00344890
Safety Study of Preservon-Treated Bone Implants for Cervical Fusion in the Treatment of Cervical Radiculopathy or Myelopathy
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298-0631
- VCU Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
|
1,2,3,or 4 level surgery
|
Experimental: Preservon
|
1,2,3,or 4 level surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Degree of subsidence
Time Frame: 3 months post-op
|
3 months post-op
|
Rate of fusion
Time Frame: 6 months post-op
|
6 months post-op
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bruce E. Mathern, M.D., VCU Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR06-001
- WIRB Protocol #20061453
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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