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iFuse Implant System® Minimally Invasive Arthrodesis

NCT01741025 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2017-10-03

No results posted yet for this study

Summary

The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint

Conditions

  • Sacroiliac Joint Pain

Interventions

DEVICE

iFuse Implant System

Placement of iFuse implant system via surgery

OTHER

Conservative Management

Medications for pain, physical therapy, cognitive behavour therapy

Sponsors & Collaborators

  • SI-BONE, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Cher · SI-BONE, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-12-15
Completion
2017-09-24

Countries

  • Belgium
  • Germany
  • Italy
  • Sweden

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 NCT01741025 on ClinicalTrials.gov