CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

Completed

• Conditions: Sacroiliitis

• Registration Number: NCT02425631
• Lead Sponsor: Zyga Technology, Inc.

Brief Summary

This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-24
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Patient must have a SImmetry device implanted.
• Patient is willing to comply with study procedures and provide informed consent.

Exclusion Criteria

• Patient is physically unable to return to the clinic for CT imaging.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SI Joint Fusion (CT evidence of SI joint fusion)	12 months	CT evidence of SI joint fusion evaluated by a core laboratory

Secondary Outcome Measures

Name	Time	Method
SI Joint Pain (CT evidence of SI joint fusion)	24 months	evaluated by a core laboratory