CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

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

Completed

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Key information

Conditions

Sacroiliitis Arthritis Joint Diseases Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SImmetry Sacroiliac Joint Fusion System

Device

Minimally invasive surgery for implantation of the SImmetry System

Primary outcomes

SI Joint Fusion (CT evidence of SI joint fusion)

Time frame: 12 months

CT evidence of SI joint fusion evaluated by a core laboratory

Secondary outcomes

SI Joint Pain (CT evidence of SI joint fusion)

Time frame: 24 months

evaluated by a core laboratory

Sponsors and collaborators

Lead sponsor

Zyga Technology, Inc.

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Apr 24, 2015
Registry last updated: Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed