Phase
Condition
Spondylolisthesis
Ankylosing Spondylitis
Spinal Stenosis
Treatment
Minuteman G5 Device
Minuteman G5
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
A subject must MEET ALL of the following inclusion criteria:
Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeledindication
Be willing and capable of giving written consent to participate in this clinicalstudy based on voluntary agreement after a thorough explanation of the subject'sparticipation has been provided
Be willing and capable of subjective evaluation, read and understand writtenquestionnaires, and read, understand the written informed consent
Be 18 years of age or older at the time of enrollment
Have been diagnosed with degenerative conditions of the lumbar spine resulting inchronic low back pain with lower extremity symptoms and concurrent neurogenicclaudication
Received at least 3 months of non-operative or conservative treatment withoutsignificant benefit in the opinion of the Investigator
Be willing and able to comply with study-related requirements, procedures and visits
Be on a stable pain medication regimen, as determined by the Investigator, for atleast 30 days prior to enrolling in this study.
Must disclose any unresolved major issues of secondary gain (e.g., social,financial, legal), as determined by the Investigator. Including being involved in aninjury claim under current litigation or has a pending or approved worker'scompensation claim. Subjects will not be excluded due to secondary gain, but itshould be disclosed at Enrollment.
Exclusion Criteria
Exclusion
A subject must NOT MEET ANY of the following exclusion criteria:
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 opinionof the Investigator
Grade II-V spondylolisthesis
Significant scoliosis with Cobb angle >10 degrees
Unremitting back pain in a spinal flexion position
Active systemic disease that may affect the welfare of the subject in the opinion ofthe Investigator
Be concurrently participating in another clinical drug and/or device study that mayalter or confound the results of the assessment (investigational device,investigational drug, new indication for a device or drug, or additional testingbeyond standard of care procedures) as determined by the investigator.
Vertebral osteoporosis or history of vertebral fracture
Be pregnant/ lactating or plan to become pregnant from study enrollment through 3months post-operatively. (determined by urine testing unless female subject issurgical sterile or post-menopausal). If female, sexually active and childbearingage, subject must be willing to use a reliable form of birth control through the 3-month visit.
Malformation or dysplasia of spinous process
Severe osteoporosis with T score <-2.5 SD
Study Design
Study Description
Connect with a study center
Vista Clinical Research
Newnan 4212684, Georgia 4197000 30265
United StatesActive - Recruiting
Comprehensive Pain & Spine Specialists
Indianapolis, Indiana 46250
United StatesSite Not Available
Comprehensive Pain & Spine Specialists
Indianapolis 4259418, Indiana 4921868 46250
United StatesActive - Recruiting
Kansas University Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Nura Precision Pain Management
Edina 5025264, Minnesota 5037779 55435
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Pacific Sports & Spine
Eugene, Oregon 97404
United StatesSite Not Available
Pacific Sports & Spine
Eugene 5725846, Oregon 5744337 97404
United StatesActive - Recruiting
Spine & Nerve Center of the Virginias
Charleston, West Virginia 25301
United StatesSite Not Available
Spine & Nerve Center of the Virginias
Charleston 4801859, West Virginia 4826850 25301
United StatesActive - Recruiting
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