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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.
Up to 150 subjects will be enrolled and treated at up to 20 study sites. Qualified subjects will be enrolled and treated with the Minuteman G5 Device. Subjects will be seen at 1-, 3-, 6- and 12-months following study treatment.
Key outcome assessments will include gait and balance testing performed using BioMech Lab sensor technology to capture and deliver three-dimensional patient motion data to a mobile device that instantly analyzes, distills, and quantifies the information. Patient reported outcome measures will also be collected to evaluate pain, quality of life and satisfaction. During the primary assessment at 12-months post-treatment subject will be offered a computerized topography (CT) scan to evaluate spinal fusion.
After completion of the Month 12 visit all subjects will be asked to complete annual visits through 5 years, which include collection of PROMs, safety review, and can be completed in person or remote.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Group | Other | patient treated with Minuteman G5 interspinous fusion device 510k cleared for degenerative conditions of the lumbar spine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minuteman G5 Device | Device | The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain (Overall, Back and Leg) using NRS/numeric rating scale | Overall pain, as well as back pain when standing/walking and leg pain when standing will be assessed using a numeric rating scale (NRS). The NRS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable. | Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years. |
| Oswestry Disability Index (ODI) | ODI is a self-reported questionnaire widely used to track changes in a patient's condition over time and evaluate the effectiveness of treatments for low back pain. The ODI consists of 10 sections, each addressing a specific aspect of daily functioning. A higher score indicates greater disability. The final score/index ranges from 0-100 scale. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. | Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years. |
| PROMIS 29 2.0 | PROMIS-29 c2.0 is a set of standardized questions that measures 29 items across 7 domains of physical and mental health. PROMIS-29 profile assesses pain intensity using a single 0-10 numeric rating scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable. And seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. Each domain is scored on T-Score Scale ranging between 22.9- 81.6 with a mean of 50 and a standard deviation of 10. | Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years. |
| Assessment of Motion using BioMech Lab testing equipment | A Primary Objective of this study is to collect real-world functional outcomes assessment of motion following treatment with the market-released Spinal Simplicity Minuteman G5 Device using BioMech Lab equipment to record gait and balance. The BioMech Lab motion analytics system will assess gait and balance via sensors placed before physical testing. |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Fusion Assessment based on review of Lumbar Computerized Tomography (CT) Scan | The secondary objective is to assess spinal fusion at 12 months post-operative using a Fusion Assessment Scale provided by Spinal Simplicity based on review of Lumbar CT Scan. | Collected at 12 months post implantation. |
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Inclusion Criteria
A subject must MEET ALL of the following inclusion criteria:
Exclusion Criteria
A subject must NOT MEET ANY of the following exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Echo Cundiff | Contact | 913-451-4414 | ecundiff@spinalsimplicity.com | |
| Adam Rogers | Contact | 913-451-4414 | arogers@spinalsimplicity.com |
| Name | Affiliation | Role |
|---|---|---|
| Tom Hedman, PhD | Spinal Simplicity | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vista Clinical Research | Recruiting | Newnan | Georgia | 30265 | United States |
Patients will be deidentified with unique study ID. Any study will be anonymized.
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| Baseline and 1-, 3- and 12-months post implantation. |
| Zurich Classification Questionnaire (ZCQ) | The ZCQ Symptom Severity, Physical Function and Subject Satisfaction allows subjects to rate their symptoms, function or satisfaction on a scale based on their experience over the past week. Symptom Severity domain evaluates the intensity of symptoms such as pain and numbness. It comprises seven items, each rated on a scale from 1 to 5. Overall symptom score ranges from 7-49; with higher scores indicating more severe symptoms. Physical Function domain assesses the impact of symptoms on daily activities. It includes five items, scored on a 1 to 4 scale. Overall symptom score ranges from 5-20; where higher scores denote greater functional impairment. Subject Satisfaction domain measures patient satisfaction with treatment outcomes. It consists of six items, each rated from 1 to 4, with higher scores reflecting greater dissatisfaction. Overall Satisfaction ranges from 6-24: where higher scores denote greater dissatisfaction. | Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years. |
| Comprehensive Pain & Spine Specialists | Recruiting | Indianapolis | Indiana | 46250 | United States |
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| University of Kansas Medical Center | Not yet recruiting | Kansas City | Kansas | 66160 | United States |
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| Nura Precision Pain Management | Recruiting | Edina | Minnesota | 55435 | United States |
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| Pacific Sports & Spine | Recruiting | Eugene | Oregon | 97404 | United States |
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| Spine & Nerve Center of the Virginias | Recruiting | Charleston | West Virginia | 25301 | United States |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
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