Clinical Trial: SAIF: Sacroiliac Fusion Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: SAIF: Sacroiliac Fusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

Brief Summary: The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion and pain reduction of the SI joint.

Detailed Summary: This is a prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 24 months.)
Sponsor: Zyga Technology, Inc.

Current Primary Outcome:

  • SI Joint Fusion [ Time Frame: 12 months ]
    Confirmed fusion of the SI joint at 12 and 24 months, defined as as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.
  • SI Joint Pain Reduction [ Time Frame: 6 months ]
    SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.


Original Primary Outcome: SI Joint Fusion [ Time Frame: 12 months ]

Confirmed fusion of the SI joint at 12 and 24 months, defined as as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.


Current Secondary Outcome: SI Joint Pain Reduction [ Time Frame: 12 and 24 months ]

SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.


Original Secondary Outcome: SI Joint Pain Reduction [ Time Frame: 12 and 24 months ]

SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 12 and 24 months.


Information By: Zyga Technology, Inc.

Dates:
Date Received: February 12, 2014
Date Started: February 2014
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016