The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
Evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
Study Type
OBSERVATIONAL
Enrollment
25
The Aspen device will be placed as posterior fixation to Posterolateral Fusion (PLF)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Community Orthopedic Medical Group
Mission Viejo, California, United States
Goodman Campbell Brian and Spine
Indianapolis, Indiana, United States
Buffalo Spine Surgery
Lockport, New York, United States
Absolute change in Oswestry Disability Index (ODI)
Time frame: baseline to 12 months post-operative
Title: Fusion success
Time frame: 12 Months post-operative
Change in Visual Analogue Scale (VAS) (pain)
Time frame: Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months
Neurological status
motor functions, reflexes, and sensory
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay)
Time frame: Surgical Visit
Pain medication usage
Time frame: Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in EQ-5D-3L
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in Zurich Claudication Questionnaire
Time frame: Baseline, 12 months & 24 months
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Pacific Spine Specialists
Tualatin, Oregon, United States