NCT02425631

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

April 16, 2015

Last Update Submit

September 12, 2016

Conditions

Sacroiliitis

Keywords

SI joint fusionSI joint painSI jointSI joint treatmentSI joint diseaseSacroiliac jointSimmetry

Outcome Measures

Primary Outcomes (1)

  • SI Joint Fusion (CT evidence of SI joint fusion)

    CT evidence of SI joint fusion evaluated by a core laboratory

    12 months

Secondary Outcomes (1)

  • SI Joint Pain (CT evidence of SI joint fusion)

    24 months

Interventions

SImmetry Sacroiliac Joint Fusion SystemDEVICE

Minimally invasive surgery for implantation of the SImmetry System

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sacroiliitis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Lisa Ingham

    Zyga

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 24, 2015

Study Start

October 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09