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

Last updated: October 1, 2025
Sponsor: Spinal Simplicity LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spondylolisthesis

Ankylosing Spondylitis

Spinal Stenosis

Treatment

Minuteman G5 Device

Minuteman G5

Clinical Study ID

NCT06355791
PDPROJ-4-TP-001-23
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

A subject must MEET ALL of the following inclusion criteria:

  1. Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeledindication

  2. Be willing and capable of giving written consent to participate in this clinicalstudy based on voluntary agreement after a thorough explanation of the subject'sparticipation has been provided

  3. Be willing and capable of subjective evaluation, read and understand writtenquestionnaires, and read, understand the written informed consent

  4. Be 18 years of age or older at the time of enrollment

  5. Have been diagnosed with degenerative conditions of the lumbar spine resulting inchronic low back pain with lower extremity symptoms and concurrent neurogenicclaudication

  6. Received at least 3 months of non-operative or conservative treatment withoutsignificant benefit in the opinion of the Investigator

  7. Be willing and able to comply with study-related requirements, procedures and visits

  8. Be on a stable pain medication regimen, as determined by the Investigator, for atleast 30 days prior to enrolling in this study.

  9. Must disclose any unresolved major issues of secondary gain (e.g., social,financial, legal), as determined by the Investigator. Including being involved in aninjury claim under current litigation or has a pending or approved worker'scompensation claim. Subjects will not be excluded due to secondary gain, but itshould be disclosed at Enrollment.

Exclusion Criteria

Exclusion

A subject must NOT MEET ANY of the following exclusion criteria:

  1. Had previous spinal surgery at the level of intervention (e.g. lumbar fusion,discectomy, Laminectomy) MILD procedure is not considered an exclusion.

  2. Patient physically unable to perform the Gait and/or Balance tests.

  3. Current systemic infection or local infection increasing the risk of surgery

  4. History of medications decreasing bone quality or soft tissue healing in the opinionof the Investigator

  5. Grade II-V spondylolisthesis

  6. Significant scoliosis with Cobb angle >10 degrees

  7. Unremitting back pain in a spinal flexion position

  8. Active systemic disease that may affect the welfare of the subject in the opinion ofthe Investigator

  9. Be concurrently participating in another clinical drug and/or device study that mayalter or confound the results of the assessment (investigational device,investigational drug, new indication for a device or drug, or additional testingbeyond standard of care procedures) as determined by the investigator.

  10. Vertebral osteoporosis or history of vertebral fracture

  11. Be pregnant/ lactating or plan to become pregnant from study enrollment through 3months post-operatively. (determined by urine testing unless female subject issurgical sterile or post-menopausal). If female, sexually active and childbearingage, subject must be willing to use a reliable form of birth control through the 3-month visit.

  12. Malformation or dysplasia of spinous process

  13. Severe osteoporosis with T score <-2.5 SD

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Minuteman G5 Device
Phase:
Study Start date:
May 29, 2024
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • Vista Clinical Research

    Newnan 4212684, Georgia 4197000 30265
    United States

    Active - Recruiting

  • Comprehensive Pain & Spine Specialists

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Comprehensive Pain & Spine Specialists

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Active - Recruiting

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Nura Precision Pain Management

    Edina 5025264, Minnesota 5037779 55435
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Pacific Sports & Spine

    Eugene, Oregon 97404
    United States

    Site Not Available

  • Pacific Sports & Spine

    Eugene 5725846, Oregon 5744337 97404
    United States

    Active - Recruiting

  • Spine & Nerve Center of the Virginias

    Charleston, West Virginia 25301
    United States

    Site Not Available

  • Spine & Nerve Center of the Virginias

    Charleston 4801859, West Virginia 4826850 25301
    United States

    Active - Recruiting

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