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

Not Applicable

• Conditions: Degenerative Conditions of the Lumbar Spine; Lumbar Spinal Stenosis; Spondylolisthesis
• Interventions: Device: Minuteman G5

• Registration Number: NCT06355791
• Lead Sponsor: Spinal Simplicity LLC

Brief 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.

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 Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-09
• Study Start: 2024-05-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-10
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical Group	Minuteman G5	patient treated with interspinous fusion device for degenerative conditions of the lumbar spine

Primary Outcome Measures

Name	Time	Method
Pain (Overall, Back and Leg) using NRS/numeric rating scale	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)	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.
PROMIS 29 2.0	Baseline and 1-, 3-, 6- and 12-months post implantation; annually out to five years.	PROMIS-29 is a set of standardized questions that measures 29 items across 7 domains of physical and mental health. Higher scores indicate better outcomes in each specific domain.
Assessment of Motion using BioMech Lab testing equipment	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)	Baseline and 1-, 3- 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. Higher scores on both scales indicate greater disability and symptom intensity.

Secondary Outcome Measures

Name	Time	Method
Spinal Fusion Assessment based on review of Lumbar Computerized Tomography (CT) Scan	Collected at 12 months post implantation.	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.

Trial Locations

Locations (5)

Comprehensive Pain & Spine Specialists; 🇺🇸 Indianapolis, Indiana, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Pacific Sports & Spine; 🇺🇸 Eugene, Oregon, United States

Spine & Nerve Center of the Virginias; 🇺🇸 Charleston, West Virginia, United States