NCT03122899

Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: SI-BONE, Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

SALLY studies sacroiliac joint fusion with the iFuse-3D implant.

Detailed description

Participants will all get sacroiliac joint fusion on this study using the iFuse-3D titanium implant, manufactured by SI-BONE, Inc. Participants will be followed for clinical outcomes at pre-planned time points on the trial. Participants will be randomized to CT scan at 6 months or 12 months, and all will also get a CT scan at 5 years, the final visit for the study.

Conditions

• Sacroiliac Dysfunction

Interventions

Type	Name	Description
DEVICE	SIJ fusion with iFuse-3D	Minimally invasive SIJ fusion with iFuse-3D titanium implant (usually 3 implants per SIJ).

Timeline

• Start date: 2017-10-03
• Primary completion: 2024-06-19
• Completion: 2024-06-19
• First posted: 2017-04-21
• Last updated: 2025-06-05

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study