Clinical Trial: Investigation of Sacroiliac Fusion Treatment (INSITE)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: INSITE Investigation of Sacroiliac Fusion Treatment

Brief 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.

Detailed Summary:
Sponsor: SI-BONE, Inc.

Current Primary Outcome: Subject Success [ Time Frame: 6 months ]

Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement in Si joint pain [ Time Frame: Screening, 1, 3, 6, 12, 18 and 24 months ]
    Improvement in SI joint pain VAS score at post-operative visits
  • Improvement in back dysfunction [ Time Frame: Screening, 1, 3, 6, 12 and 24 months ]
    Improvement in ODI at post-operative visits
  • Improvement in quality of life [ Time Frame: Baseline, 6, 12 and 24 months ]
    Improvement in QOL as measured by SF-36 PCS and ED-5D at post-operative visits
  • Ambulatory status [ Time Frame: Baseline, 1,3,6,12,18 and 24 months ]
    Time to full ambulation amongst those without full ambulation at baseline
  • Work status [ Time Frame: Baseline, 1,3,6,12,18 and 24 months ]
    Proportion of non-working subjects who return to work
  • Serious adverse events [ Time Frame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months ]
    Any event meeting ISO14155 definition for serious adverse event at following timepoints: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.


Original Secondary Outcome: Same as current

Information By: SI-BONE, Inc.

Dates:
Date Received: September 1, 2012
Date Started: September 2012
Date Completion: December 2016
Last Updated: June 3, 2015
Last Verified: June 2015