An interventional study of Posterior Lateral Fusion (PLF) and Anterior Lumbar Interbody Fusion (ALIF) in Stenosis, Spondylolisthesis and Degenerative Disc Disease, sponsored by Exactech. Terminated at 6 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2013-11-21.
Sponsored by Exactech · Not applicable, Interventional, and Treatment
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.
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's enrollment of 94 is above the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.
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This treatment arm includes autograft harvested from local bone and / or the iliac crest, supplemented with a demineralized bone matrix (DBM) autograft extender, Optecure.
Procedure: Posterior Lateral Fusion (PLF) · Procedure: Anterior Lumbar Interbody Fusion (ALIF) · Procedure: Transforaminal lumbar interbody fusion (TLIF) · Procedure: Posterior lumbar interbody fusion (PLIF) · Procedure: Extreme lateral interbody fusion (XLIF)
This treatment arm includes autograft harvested from local bone and / or the iliac crest.
Procedure: Posterior Lateral Fusion (PLF) · Procedure: Anterior Lumbar Interbody Fusion (ALIF) · Procedure: Transforaminal lumbar interbody fusion (TLIF) · Procedure: Posterior lumbar interbody fusion (PLIF) · Procedure: Extreme lateral interbody fusion (XLIF)
Posterior lateral fusion (PLF) of the lumbar spine
Also known as: PLF
Anterior lumbar interbody fusion (ALIF)
Also known as: ALIF
Transforaminal lumbar interbody fusion (TLIF)
Also known as: TLIF
Posterior lumbar interbody fusion (PLIF)
Also known as: PLIF
Extreme lateral interbody fusion (XLIF)
Also known as: XLIF
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
Oswestry Disability Index (ODI) completed at each visit
Time frame: 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
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
This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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