NCT07204288

Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices

Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Spinal Simplicity LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fusion of Spine
• Sacroiliac; Fusion

Interventions

Type	Name	Description
OTHER	Cat Scan, if applicable	CT imaging is being used to assess fusion in participants with previously implanted devices that were not explanted.

Timeline

• Start date: 2025-09-11
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-10-02
• Last updated: 2026-03-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study