Clinical Trial: iFuse Implant System® Minimally Invasive Arthrodesis

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

Official Title: A Multicenter Randomized Controlled Post-market Clinical Follow-up Trial Comparing the Effectiveness and Safety of the iFuse Implant System® Versus Conservative Management for Patients With Chron

Brief 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

Detailed Summary: This study is a multicenter randomized controlled, post-market clinical follow-up clinical trial of the iFuse Implant System for SI joint fusion vs. conservative management. Subjects assigned to conservative management may cross over to iFuse after a minimum of 6 months of conservative treatment. Conservative management does not include interventional procedures such as prolotherapy, steroid injections and/or RF ablation.
Sponsor: SI-BONE, Inc.

Current Primary Outcome: The change in lower back pain as rated by the study subject using a 0-100 visual analog scale (VAS) at 6 months after initiation of treatment [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in lower back pain (VAS) [ Time Frame: 1, 3, 12 and 24 months ]
  • Change from baseline in leg pain (VAS [ Time Frame: 1, 3, 6, 12 and 24 months ]
  • Change in disability due to back pain (ODI [ Time Frame: 3, 6, 12 and 24 months ]
  • Change in quality of life (EQ-5D [ Time Frame: 3, 6, 12 and 24 months ]
  • Change in ambulatory and work status [ Time Frame: 1, 3, 6, 12 and 24 months ]
  • Change in depression score (Zung Depression Scale [ Time Frame: 3, 6, 12 and 24 months ]
  • Change in objective functional test (ASLR [ Time Frame: 3, 6, 12 and 24 months ]
  • Change in walking distance [ Time Frame: 3, 6, 12 and 24 months ]
  • Patient satisfaction and self-rating of disease state [ Time Frame: 3, 6, 12 and 24 months ]
  • Serious adverse events [ Time Frame: during 24 months ]
  • Device breakage, loosening and migration [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: SI-BONE, Inc.

Dates:
Date Received: November 30, 2012
Date Started: June 2013
Date Completion: September 2017
Last Updated: October 13, 2016
Last Verified: October 2016