Status:
TERMINATED
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
Lead Sponsor:
Exactech
Conditions:
Stenosis
Spondylolisthesis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Autograft (bone taken from one part of the body and placed in another site on the same individual) has long been considered the gold standard for lumbar spine fusion procedures. Unfortunately, there a...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00254852
Start Date
October 1 2005
End Date
August 1 2011
Last Update
November 21 2013
Active Locations (6)
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1
Memorial Orthopaedic Surgical Group
Long Beach, California, United States, 90806
2
University of California, San Diego
San Diego, California, United States, 92103
3
Slocum Dickson Medical Group
New Hartford, New York, United States, 13413
4
State University of New York, Upstate Medical University
Syracuse, New York, United States, 13202