Minuteman G5 Device for Lumbar Spine Conditions
This study is evaluating the Minuteman G5 MIS Fusion Plate, a device made of titanium alloy, for people with degenerative (wearing down) conditions of the lower back (lumbar spine). These conditions can cause chronic low back pain, leg pain, and neurogenic claudication (leg pain or weakness when walking). The study aims to see how well the Minuteman G5 device works and if it is safe. Researchers will measure your pain levels, how well you can do daily activities (using the Oswestry Disability Index), and your overall quality of life (using PROMIS 29 2.0). The study plans to enroll up to 150 participants, and its current status is unclear.
- Study design
- This is a single-arm study, meaning all participants will receive the Minuteman G5 device. Up to 150 participants will be enrolled across multiple centers.
- What's involved
- You would have visits at 1, 3, 6, and 12 months after the device is implanted. These visits will include gait and balance testing, and questionnaires about your pain and quality of life.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 12-month visit, participants will be asked to complete annual visits for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
At a glance
Conditions
Where it's being run
6 sites across 6 statesStudy leadership
- Tom Hedman, PhD · STUDY_CHAIR · Spinal Simplicity
Who to contact
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What this trial measures
- Pain (Overall, Back and Leg) using NRS/numeric rating scaleBaseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
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.
- Oswestry Disability Index (ODI)Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
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.
- PROMIS 29 2.0Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.
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.
- Assessment of Motion using BioMech Lab testing equipmentBaseline and 1-, 3- and 12-months post implantation.
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.
- Zurich Classification Questionnaire (ZCQ)Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.
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.