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

NCT06355791 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-03

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

Minuteman G5 Device

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

Sponsors & Collaborators

  • Spinal Simplicity LLC

    lead INDUSTRY

Principal Investigators

  • Tom Hedman, PhD · Spinal Simplicity

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2026-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06355791 on ClinicalTrials.gov