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

Part of paid clinical trials in Newnan, Georgia.

Sponsor
Spinal Simplicity LLC
Study ID
NCT06355791
Status
Recruiting
Apply to this trial

Conditions

  • Degenerative Conditions of the Lumbar Spine
  • Lumbar Spinal Stenosis
  • Spondylolisthesis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Minuteman G5 Device — DEVICE
    The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy

Study Details

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.

Key Dates

Start date
May 29, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Surgical Group
    patient treated with Minuteman G5 interspinous fusion device 510k cleared for degenerative conditions of the lumbar spine

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. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Vista Clinical ResearchNewnanGeorgia30265
Debra Helton
Sandeep Vaid, MD (PRINCIPAL_INVESTIGATOR)
Comprehensive Pain & Spine SpecialistsIndianapolisIndiana46250
Esther Owusu
Andrew Trobridge, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Manuel Clark
Usman Latif, MD, MBA (PRINCIPAL_INVESTIGATOR)
Dawood Sayed, MD (SUB_INVESTIGATOR)
Nura Precision Pain ManagementEdinaMinnesota55435
Ken Farmer
R. Scott Stayner, MD (PRINCIPAL_INVESTIGATOR)
Pacific Sports & SpineEugeneOregon97404
Katie Fabian
Gregory Moore, MD (PRINCIPAL_INVESTIGATOR)
Spine & Nerve Center of the VirginiasCharlestonWest Virginia25301
Amy Young, RN-RC
Timothy Deer, MD (PRINCIPAL_INVESTIGATOR)
Christopher Kim, MD (SUB_INVESTIGATOR)

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Vista Clinical Research· Newnan, GAComprehensive Pain & Spine Specialists· Indianapolis, INUniversity of Kansas Medical Center· Kansas City, KSNura Precision Pain Management· Edina, MNPacific Sports & Spine· Eugene, ORSpine & Nerve Center of the Virginias· Charleston, WV

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