CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

Sacroiliitis Clinical Trial

Official title:

CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425631
• Other study ID #: CL1097
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: September 12, 2016
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Zyga Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosis
• Sacroiliitis

Intervention

Device:
• SImmetry Sacroiliac Joint Fusion System
Minimally invasive surgery for implantation of the SImmetry System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zyga Technology, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SI Joint Fusion (CT evidence of SI joint fusion)	CT evidence of SI joint fusion evaluated by a core laboratory	12 months	No
Secondary	SI Joint Pain (CT evidence of SI joint fusion)	evaluated by a core laboratory	24 months	No