About this trial

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.

Eligibility criteria

Qualifiers

Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeled indication

Be willing and capable of giving written consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided

Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand the written informed consent

Be 18 years of age or older at the time of enrollment

Disqualifiers

Had previous spinal surgery at the level of intervention (e.g. lumbar fusion, discectomy, Laminectomy) MILD procedure is not considered an exclusion.

Patient physically unable to perform the Gait and/or Balance tests.

Current systemic infection or local infection increasing the risk of surgery

History of medications decreasing bone quality or soft tissue healing in the opinion of the Investigator

Trial design

Treatments tested in this trial

  • Minuteman G5 Device

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

6
Georgia
Vista Clinical Research30265, Newnan United States
Indiana
Comprehensive Pain & Spine Specialists46250, Indianapolis United States
Kansas
University of Kansas Medical Center66160, Kansas City United States
Minnesota
Nura Precision Pain Management55435, Edina United States

Sponsors and collaborators

Spinal Simplicity LLC

Lead sponsor