Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
A Single Blind, Multi-Center, Randomized, Prospective Clinical Study Comparing Optecure™ Autograft Extender to Autograft Only in Fusion of the Lumbar Spine
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(and used to aid in assessment of bridging bone, where appropriate).
Study Overview
Status
Conditions
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 are complications involved with autograft harvest such as donor site morbidity, increased operating time, and limited supply. Therefore, the use of allograft (bone taken from one body and placed into another individual) as a graft extender has become an acceptable practice, especially in fusions of more than one level where larger quantities of graft material are needed.
In this study, comparisons will be made between patients who are randomized to having fusion with an allograft material (Optecure, Exactech, Inc.) mixed with an autograft to those patients who are randomized to having fusion with autograft alone.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Long Beach, California, United States, 90806
- Memorial Orthopaedic Surgical Group
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San Diego, California, United States, 92103
- University of California, San Diego
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New York
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New Hartford, New York, United States, 13413
- Slocum Dickson Medical Group
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Syracuse, New York, United States, 13202
- State University of New York, Upstate Medical University
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Tennessee
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Bristol, Tennessee, United States, 37620
- NeuroSpine Solutions, P.C.
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Washington
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Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
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: O
This treatment arm includes autograft harvested from local bone and / or the iliac crest, supplemented with a demineralized bone matrix (DBM) autograft extender, Optecure.
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Posterior lateral fusion (PLF) of the lumbar spine
Other Names:
Anterior lumbar interbody fusion (ALIF)
Other Names:
Transforaminal lumbar interbody fusion (TLIF)
Other Names:
Posterior lumbar interbody fusion (PLIF)
Other Names:
Extreme lateral interbody fusion (XLIF)
Other Names:
|
|
Active Comparator: A
This treatment arm includes autograft harvested from local bone and / or the iliac crest.
|
Posterior lateral fusion (PLF) of the lumbar spine
Other Names:
Anterior lumbar interbody fusion (ALIF)
Other Names:
Transforaminal lumbar interbody fusion (TLIF)
Other Names:
Posterior lumbar interbody fusion (PLIF)
Other Names:
Extreme lateral interbody fusion (XLIF)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Radiographic evidence of fusion on x-rays taken at each post-op visit
Time Frame: Immediate post-op, 6-week, 3-month, 6-month, 1-year, 2-year
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Immediate post-op, 6-week, 3-month, 6-month, 1-year, 2-year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Oswestry Disability Index (ODI) completed at each visit
Time Frame: pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
|
pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
|
|
SF-12 patient health surveys completed at each visit
Time Frame: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
|
Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
|
|
Perceived pain noted on visual analog scales (VAS) at each visit
Time Frame: Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
|
Pre-operative, 6-week, 3-month, 6-month, 1-year, 2-year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amir Fayyazi, MD, VSAS Orthopedics
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR04-004
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