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Clinical Trial Title
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
Location and Contact Information
University of California, San Diego
Location and Contact Information
Memorial Orthopaedic Surgical Group
Location and Contact Information
State University of New York, Upstate Medical University
Location and Contact Information
Slocum Dickson Medical Group
Location and Contact Information
NeuroSpine Solutions, P.C.
Location and Contact Information
Madigan Army Medical Center
Status Active, not recruiting
Sponsors
Exactech
Purpose
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to
autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one
level is defined as two adjacent vertebrae), L2 and below.
The primary endpoint will be the assessment of fusion by evaluation of x-rays taken
following surgery at each visit. The x-ray evaluation will be conducted by a radiologist
who is blinded to the type of treatment each patient has received.
Subjects will be seen at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperative
(post-op). Questionnaires and x-rays will be completed at each visit and a computed
tomography (CT) scan will be taken at the 12 month visit.
Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Eligibility
Genders Eligible for Study: Both
Ages eligible for study: 21 Years to N/A
Inclusion Criteria:
- Patient is indicated for primary lumbar fusion of 1 or 2 segments, L2 to S1
- Patient is willing to be blindly randomized to treatment or control and remain
blinded for 2 years of follow-up
- Patient is at least twenty-one (21) years of age
- Patient is expected to survive at least 2 years beyond surgery
- Patient is willing to participate by complying with pre- and postoperative visit
requirements, including: completion of questionnaires, functional performance tests,
and radiographs/CT scan
- Patient is willing and able to review and sign a study Informed Consent form
Exclusion Criteria:
- Patient has a mental or physical condition that would invalidate evaluation results
- Patient is pregnant
- Patient is a prisoner
- Patient has a systemic infection or infection at the proposed surgical site
- Patient has osteopenia, osteoporosis, or osteomalacia to a degree that spinal
instrumentation would be contraindicated
- Patient has a disease of bone metabolism
- Patient is undergoing chemotherapy or radiation treatment
- Patient is currently involved in a study of another product for a similar purpose
- Patient requires post-op management with nonsteroidal anti-inflammatory drugs
(NSAIDs)
More Information
Study ID numbers:
CR04-004
ClinicalTrials Identifier - NCT00254852
For additional information, visit ClinicalTrials.gov.
Information obtained from ClinicalTrials.gov on 11/23/2009
This directory includes clinical trials that involve researchers at UCSD Medical
Center. The information was obtained from ClinicalTrials.gov, a database of the
U.S. National Institutes of Health.
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