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LOIS: Long-Term Follow-Up in INSITE/SIFI

NCT02270203 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 103

Last updated 2019-08-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).

Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are:

* SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and
* INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement

Conditions

  • Degenerative Sacroilitis
  • Sacroiliac Joint Disruption

Interventions

RADIATION

Pelvic CT at 5 years post-op

Pelvic CT at 5 years post-op

Sponsors & Collaborators

  • SI-BONE, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Cher, MD · SI-BONE, Inc.

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-07-31
Completion
2019-07-31

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 NCT02270203 on ClinicalTrials.gov