SI Joint Stabilization in Long Fusion to the Pelvis — SILVIA

Sacroiliac Joint Disruption Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04062630
Study type	Interventional
Source	SI-BONE, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 20, 2020
Completion date	December 2024

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See also
Status	Clinical Trial	Phase
Completed	`NCT01681004` - Investigation of Sacroiliac Fusion Treatment (INSITE)	N/A
Completed	`NCT02270203` - LOIS: Long-Term Follow-Up in INSITE/SIFI
Recruiting	`NCT05633888` - Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System	N/A
Enrolling by invitation	`NCT05628142` - Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study	N/A
Active, not recruiting	`NCT01640353` - Sacroiliac Joint Fusion With iFuse Implant System (SIFI)	Phase 4