Degenerative Disc Disease Clinical Trial
Official title:
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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