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Investigation of Sacroiliac Fusion Treatment (INSITE)

NCT01681004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2017-08-25

Study results available
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Summary

The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo specific, targeted non-surgical treatment of the SI joint.

Conditions

  • Degenerative Sacroiliitis
  • Sacroiliac Joint Disruption

Interventions

DEVICE

iFuse Implant System

Placement of iFuse implant system via surgery

OTHER

Non-surgical management

Medications for pain, physical therapy, SI joint injection and RF ablation

Sponsors & Collaborators

  • SI-BONE, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel J Cher, MD · SI-BONE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-02-28
Completion
2017-06-30

Countries

  • United States

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 NCT01681004 on ClinicalTrials.gov