LUMBAR & SACROILIAC FUSION STUDY

Spinal Simplicity

Status: Enrolling

Conditions: Sacroiliac; Fusion; Fusion of Spine

Treatments: Other: Cat Scan, if applicable

Study type: Interventional

Funder types: Industry

Identifiers

NCT07204288

SSMMSI-2025-CIP

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

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

Other group

Description:

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.

Treatment:

Other: Cat Scan, if applicable