Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices (FUSION)

Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)

This study is a multi-center, observational, prospective and retrospective data collection study

Study Overview

• Status: Recruiting
• Conditions: Fusion of Spine; Sacroiliac; Fusion
• Intervention / Treatment: Other: Cat Scan, if applicable

Detailed Description

The purpose of this study is to evaluate fusion outcomes and patient-reported outcomes for Spinal Simplicity's lumbar and/or sacroiliac fusion implants: the Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device. This will involve identifying patients previously implanted with any of these devices and conducting both retrospective and prospective data collection/analysis.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Echo Cundiff; Phone Number: 9134514414; Email: ecundiff@spinalsimplicity.com
• Study Contact Backup: Name: Adam Rogers; Phone Number: 9134514414; Email: arogers@spinalsimplicity.com

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Recruiting
      • Crimson Pain Management
      • Principal Investigator: Daniel Kloster, MD
      • Contact: Morteza Rabii, NP
    • Overland Park, Kansas, United States, 66210
      • Recruiting
      • Nuroscience Research Center
      • Contact: Amy Reinert
      • Principal Investigator: Mayank Gupta, MD
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Recruiting
      • Nura Precision Pain Management
      • Contact: Ken Farmer
      • Principal Investigator: R. Scott Stayner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be 18 years of age or older at the time of enrollment
2. Be willing and able to provide informed consent and comply with study visit requirements
3. Subjects who received a Spinal Simplicity fusion implant(s) (Minuteman G5, Liberty, and/or Patriot) between April 1, 2022 and March 31, 2025

Exclusion Criteria:

1. Unable to provide consent and complete prospective data collection
2. Women who are pregnant, or may become pregnant, during the course of the study
3. Contraindication to CT scanning, in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Previously implanted with lumbar and/or sacroiliac fusion device(s); This study will involve patients previously commercially implanted with Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device. Subjects will undergo a CT scan, if applicable and PROs.	Other: Cat Scan, if applicable; CT imaging is being used to assess fusion in participants with previously implanted devices that were not explanted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate radiographic outcomes	The primary endpoints include the rate of fusion, and the rate of complications or reoperations. Fusion Scale:1) Radiographically evaluate the rate of fusion, as determined by a panel of independent radiologists per the below fusion assessment metrics: Lumbar fusion grading scale (Minuteman G5): 1- Definitely fused 2- Probably fused 3- Probably not fused 4- Definitely not fused; Sacroiliac fusion assessment (Liberty, Patriot): Device(s) will be evaluated for (i) the presence of bridging bone from ilium to sacrum; and (ii) any evidence of migration or loosening Additionally, if Minuteman G5 subjects have an interbody fusion device, interbody fusion will be assessed using the Bridwell scale: 1- Definite fusion 2- Probable fusion 3- Intermediate fusion/possible motion 4- Pseudoarthrosis/no bony connection	Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS/ Numeric Rating Scale	1. Pain (Overall, Back and Leg) using NRS/numeric rating scale 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.	Enrollment
ODI/ Oswestry Disability Index	Oswestry Disability Index (ODI) 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. The final score/index ranges from 0-100 scale. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed bound.	Enrollment
PGIC/ Patient Global Impression of Change	The Patient Global Impression of Change (PGIC) PGIC is a standardized tool designed to assess a patient's self-reported perception of improvement or worsening in their health status over time. The PGIC consists of 1 question, using a 1 to 7 scale: 1-Very Much Improved to 7-Very much Worse.	Enrollment
Subject Satisfaction Survey	Subject Satisfaction Survey Subject Satisfaction Survey is made up of 8 questions designed to assess a patient's self-reported satisfaction or dissatisfaction on a Likert scale. The Likert scale consists of 8 questions individually scored on a 1 to 5 scale: With lower scores indicating higher satisfaction and higher scores indicating greater dissatisfaction.	Enrollment

Collaborators and Investigators

• Sponsor: Spinal Simplicity LLC
• Investigators: Study Chair: Tom Hedman, PhD, Spinal Simplicity LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: September 24, 2025
• First Posted (Actual): October 2, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SSMMSI-2025-CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be published at the sponsor's discretion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No