Degenerative Conditions of the Lumbar SpineSTABILITYNCT06355791
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
A study testing Minuteman G5 Device in people with Degenerative Conditions of the Lumbar Spine and Lumbar Spinal Stenosis, run by Spinal Simplicity LLC at 7 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis, Spondylolisthesis
- What is being tested?
- Minuteman G5 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 May 2024to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject must MEET ALL of the following inclusion criteria:
- 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
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- 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 approved worker's compensation claim. Subjects will not be excluded due to secondary gain, but it should be disclosed at Enrollment.
Who cannot join
- 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
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- 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 additional testing beyond 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 3 months post-operatively. (determined by urine testing unless female subject is surgical sterile or post-menopausal). If female, sexually active and childbearing age, 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Spine & Nerve Center of the Virginias
Charleston, West Virginia, 25301
Amy Young, RN-RC
Timothy Deer, MD
- Recruiting
Nura Precision Pain Management
Edina, Minnesota, 55435
Ken Farmer
R. Scott Stayner, MD
- Recruiting
Pacific Sports & Spine
Eugene, Oregon, 97404
Katie Fabian
Gregory Moore, MD
- Recruiting
Comprehensive Pain & Spine Specialists
Indianapolis, Indiana, 46250
Esther Owusu
Andrew Trobridge, MD
- Not yet recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Manuel Clark
Usman Latif, MD, MBA
- Recruiting
Vista Clinical Research
Newnan, Georgia, 30265
Debra Helton
Sandeep Vaid, MD
- Recruiting
Paradigm Health System
Slidell, Louisiana, 70458
Chris RC, 985-882-4500, cminnerly@paradigmhealth.net
Neilson Tran, MD
About this study
Official title: The Stability Study: Open-Label, Multi-Center, Post-Market Study of Functional Motion Outcomes In Subjects Treated With the Spinal Simplicity Minuteman G5 Fusion Plate
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.
Read the detailed description
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.
- Being tested
- Minuteman G5 Device
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minuteman G5 DeviceDevice
The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy
| Study group | Role | What they receive |
|---|---|---|
| Surgical Group | Other | patient treated with Minuteman G5 interspinous fusion device 510k cleared for degenerative conditions of the lumbar spine Receives: Device: Minuteman G5 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.
Secondary outcomes (1)
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.
Measured: Collected at 12 months post implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start29 May 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Conditions of the Lumbar SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spinal Simplicity LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Hedman, PhD, Study chair, Spinal Simplicity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355791
- Sponsor's protocol ID
- PDPROJ-4-TP-001-23
- Acronym
- STABILITY
- Status last verified
- Nov 2026
- First submitted
- 26 Mar 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Patients will be deidentified with unique study ID. Any study will be anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Stability Study: Open-Label, Multi-Center, Post-Market Study of Functional Motion Outcomes In Subjects Treated With the Spinal Simplicity Minuteman G5 Fusion Plate
- ClinicalTrials.gov ID
- NCT06355791
- Acronym / sponsor ID
- STABILITY / PDPROJ-4-TP-001-23
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Spinal Simplicity LLCIndustry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Group | Other | Device: Minuteman G5 Devicepatient treated with Minuteman G5 interspinous fusion device 510k cleared for degenerative conditions of the lumbar spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minuteman G5 DeviceThe Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy | Device | Surgical Group |
Primary outcome
Pain (Overall, Back and Leg) using NRS/numeric rating scale
Time frame: Baseline 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)
Time frame: 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 2.0
Time frame: Baseline 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 equipment
Time frame: Baseline 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)
Time frame: 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.
1 secondary outcome
Spinal Fusion Assessment based on review of Lumbar Computerized Tomography (CT) Scan
Time frame: Collected at 12 months post implantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Patients will be deidentified with unique study ID. Any study will be anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tom Hedman, PhD study chair
Spinal Simplicity
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minuteman G5 Device in people with Degenerative Conditions of the Lumbar Spine and Lumbar Spinal Stenosis, run by Spinal Simplicity LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Echo Cundiff (913-451-4414, ecundiff@spinalsimplicity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (Overall, Back and Leg) using NRS/numeric rating scale (time frame: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.