CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

September 12, 2016 updated by: Zyga Technology, Inc.
This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with the SImmetry System will be recruited for this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SI Joint Fusion (CT evidence of SI joint fusion)
Time Frame: 12 months
CT evidence of SI joint fusion evaluated by a core laboratory
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SI Joint Pain (CT evidence of SI joint fusion)
Time Frame: 24 months
evaluated by a core laboratory
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zyga Technology, Inc.

Investigators

  • Study Director: Lisa Ingham, Zyga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (ESTIMATE)

April 24, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL1097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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