RecruitingNot Applicable

Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device

United States150 participantsStarted 2024-05-29

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. Received at least 3 months of non-operative or conservative treatment without significant benefit in the opinion of the Investigator

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain (Overall, Back and Leg) using NRS/numeric rating scale

Timeframe: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

Oswestry Disability Index (ODI)

Timeframe: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

PROMIS 29 2.0

Timeframe: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

Assessment of Motion using BioMech Lab testing equipment

Timeframe: Baseline and 1-, 3- and 12-months post implantation.

Zurich Classification Questionnaire (ZCQ)

Timeframe: Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.

Trial details

NCT IDNCT06355791

SponsorSpinal Simplicity LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Echo Cundiff

913-451-4414 ecundiff@spinalsimplicity.com

View on ClinicalTrials.gov More Degenerative Conditions of the Lumbar Spine trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. Received at least 3 months of non-operative or conservative treatment without significant benefit in the opinion of the Investigator

What they're measuring

Pain (Overall, Back and Leg) using NRS/numeric rating scale

Timeframe: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

Oswestry Disability Index (ODI)

Timeframe: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

PROMIS 29 2.0

Timeframe: Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.

Assessment of Motion using BioMech Lab testing equipment

Timeframe: Baseline and 1-, 3- and 12-months post implantation.

Zurich Classification Questionnaire (ZCQ)

Timeframe: Baseline and 1-, 3- 6- and 12-months post implantation; annually out to five years.

Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria