Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Spinal Simplicity LLC
- Enrollment
- 500
- Locations
- 3
- Primary Endpoint
- Investigate radiographic outcomes
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Cat Scan, if applicable (Other)
Outcomes
Primary Outcomes
Investigate radiographic outcomes
Time Frame: Enrollment
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
Secondary Outcomes
- NRS/ Numeric Rating Scale(Enrollment)
- ODI/ Oswestry Disability Index(Enrollment)
- PGIC/ Patient Global Impression of Change(Enrollment)
- Subject Satisfaction Survey(Enrollment)