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New treatment option for Degenerative Conditions of the Lumbar Spine
Official title Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
ClinicalTrials.gov ID: NCT06355791
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A subject must MEET ALL of the following
- 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...
- 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
You likely can't join if
- 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 opinion of the Investigator
- Grade II-V spondylolisthesis
See the full eligibility criteria
- A subject must MEET ALL of the following
- 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
- Have been diagnosed with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication
- Received at least 3 months of non-operative or conservative treatment without significant 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 at least 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 an injury claim under current litigation or has a pending or...
- 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 opinion of 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 of the Investigator
- Be concurrently participating in another clinical drug and/or device study that may alter or confound the results of the assessment (investigational device, investigational drug, new indication for a device or drug, or...
- Vertebral osteoporosis or history of vertebral fracture
- Be pregnant/ lactating or plan to become pregnant from study enrollment through 3 months post-operatively. (determined by urine testing unless female subject is surgical sterile or post-menopausal). If female, sexually...
- Malformation or dysplasia of spinous process
- Severe osteoporosis with T score \<-2.5 SD
The study team makes the final eligibility decision.
Where it's taking place
- Newnan, Georgia, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Edina, Minnesota, United States
- Eugene, Oregon, United States
- Charleston, West Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newnan, Georgia, United States; Indianapolis, Indiana, United States; Kansas City, Kansas, United States; Edina, Minnesota, United States; Eugene, Oregon, United States; Charleston, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.