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SI Joint Stabilization in Long Fusion to the Pelvis

NCT04062630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2025-02-18

No results posted yet for this study

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.

Conditions

  • Sacroiliac Joint Disruption
  • Scoliosis Lumbar Region

Interventions

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.

Sponsors & Collaborators

  • SI-BONE, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Cher, MD · SI-BONE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2024-12-17
Completion
2025-01-15

Countries

  • United States
  • Australia
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062630 on ClinicalTrials.gov