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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
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.
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
    Cat Scan is being used to assess fusion in previously implanted population

Recruiting Locations

Crimson Pain Management
Overland Park 4276873, Kansas 4273857 66209
Contact:
Morteza Rabii, NP

Nuroscience Research Center
Overland Park 4276873, Kansas 4273857 66210
Contact:
Amy Reinert

Nura Precision Pain Management
Edina 5025264, Minnesota 5037779 55435
Contact:
Ken Farmer

More Details

NCT ID
NCT07204288
Status
Recruiting
Sponsor
Spinal Simplicity LLC

Study Contact

Echo Cundiff
9134514414
ecundiff@spinalsimplicity.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center