Patients diagnosed with single-level degenerative disc disease (DDD) of the lumbar spine undergo a posterior decompression followed by a fusion complete with a spinous process plate, graft, and a biologic.
Interlaminar lumbar instrumented fusion (ILIF™) is a compound surgical solution to spinal stenosis, combining direct neural decompression with an allograft interspinous spacer (ExtenSure® H2) to maintain the segmental distraction, and a spinous process fixation plate (Affix™) to maintain stability for eventual segmental fusion. Because this compound solution requires only a midline incision rather than the far lateral exposure necessary in posterolateral fusion with pedicle screws, it is less invasive to the patient, and therefore should result in less postoperative pain and disability, broadening the applicability of the procedure to even those advanced in age or with existing comorbidities. Subjects will be followed for 24 months following surgery to determine the changes in ODI scores from preoperative to baseline assessments. This data will be compared to published data on similar procedures.
Study Type
OBSERVATIONAL
Enrollment
77
Interlaminar lumbar instrumented fusion (ILIF™) is a compound surgical solution to spinal stenosis, combining direct neural decompression with an allograft interspinous spacer (ExtenSure® H2) to maintain the segmental distraction, and a spinous process fixation plate (Affix™) to maintain stability for eventual segmental fusion.
Desert Institute for Spine Care, Surgical Specialty Hospital of Arizona
Phoenix, Arizona, United States
The Spine Institute, St. John's Health Center
Santa Monica, California, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
The change in Oswestry Disability Index scores at 24 months compared to baseline.
Time frame: preoperative to 24 months follow-up
The change in subject self-reported pain ratings (VAS scores) at 24 months compared to baseline
Time frame: pre-op to 24 months follow-up
The change in Zurich Claudication Questionnaire scores at 24 months compared to baseline
Time frame: pre-op to 24 months follow-up
The rate of surgical and/or postoperative complications attributable to ILIF™ requiring secondary surgical intervention
Time frame: pre-op to 24 months follow-up
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