SAIF: Sacroiliac Fusion Study (SAIF)

SAIF: Sacroiliac Fusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

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

Study Overview

• Status: Terminated
• Conditions: Sacroiliac Joint Dysfunction
• Intervention / Treatment: Device: SImmetry Implant

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 Type: Observational
• Enrollment (Actual): 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and representing candidates' for SIJ fusion.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: SImmetry Implant; The SImmetry system is commercially available. The implanted devices consist of a range of thread-tapping cannulated implants designed to transfix the sacrum and ilim, providing stability for intra-articular fusion. The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SI Joint Fusion	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.	12 months
SI Joint Pain Reduction	SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zyga Technology, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (ESTIMATE): February 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: SI joint; sacroiliac joint fusion; SIJ fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: CLP 007-001