NCT04062630

SI Joint Stabilization in Long Fusion to the Pelvis

Sacroiliac Joint Stabilization in Long Fusion to the Pelvis: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: SI-BONE, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.

Detailed description

This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.

Conditions

• Sacroiliac Joint Disruption
• Scoliosis Lumbar Region

Interventions

Type	Name	Description
DEVICE	iFuse 3-D in Bedrock Configuration	Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed, additionally iFuse 3-D implants are placed in a trajectory parallel to the S2AI screws.
PROCEDURE	Multilevel Lumbar Fusion surgery	Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.

Timeline

• Start date: 2020-05-20
• Primary completion: 2024-12-17
• Completion: 2025-01-15
• First posted: 2019-08-20
• Last updated: 2025-02-18

Locations

31 sites across 5 countries: United States, Australia, Germany, Italy, United Kingdom