Clinical Trial: SI Joint Fusion and Decortication Using the SImmetry System

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

Official Title: SI Joint Fusion and Decortication Using the SImmetry System

Brief Summary: The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief of SI joint pain symptoms.

Detailed Summary: This is a prospective, non-randomized post market study designed to collect data on SI joint fusion and subject back pain following implant of the SImmetry device. The study will be conducted at a single site and 25 subjects will be implanted 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: 24 months ]
    Number of participants with radiographic evidence of fusion of the SI joint, defined 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: Same as current

Current Secondary Outcome: SI Joint Pain Reduction [ Time Frame: 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: Same as current

Information By: Zyga Technology, Inc.

Dates:
Date Received: September 23, 2015
Date Started: August 2015
Date Completion: August 2019
Last Updated: March 29, 2016
Last Verified: March 2016