The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.
Study Type
OBSERVATIONAL
Enrollment
177
* Posterolateral Fusion (PLF) * Posterior Lumbar Interbody Fusion (PLIF) * Transforaminal Lumbar Interbody Fusion (TLIF)
University of California San Francisco
San Francisco, California, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Kansas University Medical Center
Kansas City, Kansas, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Missouri
Columbia, Missouri, United States
Washington University
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University / Rothman Institute
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
...and 4 more locations
Change in Oswestry Disability Index Score v2.1a
Time frame: between pre-operative and 730 days (24 months)
Change in Numeric Pain Rating Scale (Pain NRS) for low back pain
Time frame: between pre-operative and 730 days (24 months)
Change in EQ-5D-3L health utility index
Time frame: between pre-operative and 730 days
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