Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cat Scan, if applicable.
- Who it may be relevant to
- Registry conditions: Fusion of Spine, Sacroiliac; Fusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)
Overview
This study is a multi-center, observational, prospective and retrospective data collection study
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.
Interventions
- Other Cat Scan, if applicable
CT imaging is being used to assess fusion in participants with previously implanted devices that were not explanted.
Primary outcome measures
- Investigate radiographic outcomes [Time frame: Enrollment]
Secondary outcome measures (4)
- NRS/ Numeric Rating Scale [Time frame: Enrollment]
- ODI/ Oswestry Disability Index [Time frame: Enrollment]
- PGIC/ Patient Global Impression of Change [Time frame: Enrollment]
- Subject Satisfaction Survey [Time frame: Enrollment]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 3 centers
- Crimson Pain Management — Overland Park
- Nuroscience Research Center — Overland Park
- Nura Precision Pain Management — Edina
Identifiers
NCT: NCT07204288 · SSMMSI-2025-CIP