Clinical Trial: Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

Brief Summary: The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally invasive surgical procedure (one that uses a smaller incision and less damage to the skin and other tissues than standard surgery). The purpose of implanting the device is to stabilize and fuse the SI joint.

Detailed Summary:
Sponsor: SI-BONE, Inc.

Current Primary Outcome: Subject Success [ Time Frame: Baseline and 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: 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.


Current Secondary Outcome:

  • Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm) [ Time Frame: 24 months ]
    The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain.
  • Change in Back Dysfunction [ Time Frame: 24 months ]
    Oswestry Disability Index is a validated patient questionnaire aiming to assess low back pain. The computed scores can be 0% to 100%. Lower scores indicate low disability while high scores indicate high disability. There are 10 questions on the questionnaire. Each has 6 possible answers (0 points - 5 points). If the question is skipped, it's points are subtracted from the denominator. If the raw score is 30 and all 10 questions were answered, the calculation would be 30 / 50 = 60%. If one question was skipped, it would be 30 / 45 = 67%.
  • Change in Quality of Life [ Time Frame: Baseline and 24 months ]
    Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits
  • Ambulatory Status [ Time Frame: 24 months ]
    Percentage of population fully ambulatory at 24 months post operatively.
  • Work Status [ Time Frame: Basline, 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 ]
    Occurrence of adverse events meeting the ISO14155:2011 definition of serious occurring during the procedure, at the time of hospital discharge (typically day of or next day after procedure), and at various times in late follow-up.


Original 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 EQ-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 ]
    Occurrence of adverse events meeting the ISO14155:2011 definition of serious occurring during the procedure, at the time of hospital discharge (typically day of or next day after procedure), and at various times in late follow-up.


Information By: SI-BONE, Inc.

Dates:
Date Received: July 6, 2012
Date Started: July 2012
Date Completion:
Last Updated: February 3, 2017
Last Verified: February 2017