SAIF: Sacroiliac Fusion Study

Terminated

• Conditions: Sacroiliac Joint Dysfunction
• Interventions: Device: SImmetry Implant

• Registration Number: NCT02064322
• Lead Sponsor: Zyga Technology, Inc.

Brief Summary

The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion and pain reduction of the SI joint.

Detailed Description

This is a prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 24 months.)

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling
• Subject has three (3) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's
• Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6 months prior to surgery; for example, use of medications, braces, SI belts, orthotics, physical therapy or manual manipulation
• The subject has one (1) positive diagnostic SIJ injection, resulting in a ≥50% decrease in pain from the anesthetic portion of the injection
• The subject has VAS back pain score of ≥ 60 mm
• The subject has an ODI ≥ 40%
• The subject is at least 18 years of age and skeletally mature
• The subject agrees and is able to comply with study requirements

Exclusion Criteria

• Subjects contraindicated per the cleared labeling will be excluded from participation in the study
• The subject has pelvic soft tissue or bony tumors
• The subject has had any trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit
• The subject has a history of a central nervous system (CNS) disorder(s)
• The subject is pregnant or is planning on becoming pregnant in the next two years
• The subject has chemical dependency problems as evidenced by a history of drug abuse which is documented in their past medical history or is elicited from an interview
• The subject has a history of significant emotional or psychosocial disturbance (anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SImmetry Implant	SImmetry Implant	Subjects who are indicated for the SImmetry Device according to the approved product labeling and inclusion/exclusion criteria will receive a SImmetry implant.

Primary Outcome Measures

Name	Time	Method
SI Joint Fusion	12 months	Confirmed fusion of the SI joint at 12 and 24 months, defined as as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.
SI Joint Pain Reduction	6 months	SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.

Secondary Outcome Measures

Name	Time	Method
SI Joint Pain Reduction	12 and 24 months	SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.