Clinical Trial: Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.

Detailed Summary: This is a prospective, non-randomized post market study designed to evaluate fusion and pain reduction following the use of the SImmetry System. This study will be conducted at up to 40 sites and 250 total subjects will be enrolled and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.
Sponsor: Zyga Technology, Inc.

Current Primary Outcome:

  • SI Joint Fusion [ Time Frame: 12 months ]
    Fusion of the SI joint at 12 and 24 months, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium. This will be assessed by an independent core laboratory
  • 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 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 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.
  • Disability [ Time Frame: 6 months ]
    Functional ability as determined by the Oswestry Disability Index
  • Quality of Life [ Time Frame: 6 months ]
    Quality of life assessment


Original Secondary Outcome: SI Joint Pain Reduction [ Time Frame: 12 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 26, 2014
Date Started: January 2014
Date Completion: December 2019
Last Updated: May 17, 2017
Last Verified: August 2016