The purpose of this study is to compare the physical capability outcomes of patients who undergo single-level ProDisc-L disc replacement with those of patients who undergo stand-alone, single-level anterior lumbar interbody fusion (ALIF). This study will be the first multi-center clinical study to use clearly measurable outcomes from physical tests to compare the results of lumbar disc arthroplasty with disc fusion.
Physical capability testing will be conducted once before surgery and at 6 months and 1 year after surgery. Physical capability testing assesses the ability to perform a number of common tasks: the distance a subject can walk comfortably in 6 minutes; the amount of weight a subject can lift, push, pull, and carry; and the ability to squat and work bending forward in the kneeling and standing positions. The results of this testing will be evaluated to determine whether the subject's physical capability meets the physical requirements of their job, based on their responses to a pre-study questionnaire. Each physical capability testing session will require from 1 to 1 ½ hours of the subject's time. Physical capability testing will be provided without charge.
Study Type
OBSERVATIONAL
Enrollment
45
University of Colorado Denver
Denver, Colorado, United States
Christiana Spine Center
Newark, Delaware, United States
Capital Regional Medical Center
Tallahassee, Florida, United States
Orthopaedic Surgery Associates of Marquette, PC
Marquette, Michigan, United States
Change in physical capability outcomes (6 minute walk; squats; light board game task standing bent forward /kneeling; floor-to-waist lift; horizontal lift; static push/pull force)
Time frame: pre-op, at 6mo., and at 12mo.
Oswestry Disability Index
Time frame: pre-op, at 6mo., and at 12mo
EQ-5D Health Questionnaire
Time frame: pre-op, at 6mo., and at 12mo.
Visual Analog Scale (VAS) scores for pain severity and frequency
Time frame: pre-op, at 6mo., and at 12mo.
SF-36 scores for the 8 Domains
Time frame: pre-op, at 6mo., and at 12mo.
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Texas Back Institute
Plano, Texas, United States
Gundersen Lutheran Health System
La Crosse, Wisconsin, United States