This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.
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Pain (Overall, Back and Leg) using NRS/numeric rating scale
Timeframe: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
Oswestry Disability Index (ODI)
Timeframe: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
PROMIS 29 2.0
Timeframe: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
Assessment of Motion using BioMech Lab testing equipment
Timeframe: Baseline and 1-, 3- and 12-months post implantation.
Zurich Classification Questionnaire (ZCQ)
Timeframe: Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.