Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices

NCT07204288 | Recruiting FDA Device

• 1 other identifier: SSMMSI-2025-CIP
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Fusion of Spine; Sacroiliac; Fusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• NRS/ Numeric Rating Scale

  Enrollment

• ODI/ Oswestry Disability Index

  Enrollment

• PGIC/ Patient Global Impression of Change

  Enrollment

• Subject Satisfaction Survey

  Enrollment

Study Arms (1)

Previously implanted with lumbar and/or sacroiliac fusion device(s)

OTHER

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

Interventions

Cat Scan, if applicable OTHER

CT imaging is being used to assess fusion in participants with previously implanted devices that were not explanted.

Previously implanted with lumbar and/or sacroiliac fusion device(s)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Spinal Simplicity LLC: lead

Study Sites (3)

Crimson Pain Management

Overland Park, Kansas, 66209, United States

RECRUITING

Nuroscience Research Center

Overland Park, Kansas, 66210, United States

RECRUITING

Nura Precision Pain Management

Edina, Minnesota, 55435, United States

RECRUITING

Study Officials

• Tom Hedman, PhD

  Spinal Simplicity LLC

  STUDY CHAIR

Central Study Contacts

Echo Cundiff

CONTACT

9134514414; ecundiff@spinalsimplicity.com

Adam Rogers

CONTACT

9134514414; arogers@spinalsimplicity.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will involve patients previously commercially implanted with Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)