SAIF: Sacroiliac Fusion Study

Sacroiliac Joint Dysfunction Clinical Trial

— SAIF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02064322
• Other study ID #: CLP 007-001
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2014
• Last updated: April 6, 2015
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: Zyga Technology, Inc.
• Contact: Lisa Ingham
• Email: lingham[@]zyga.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Joint Diseases
• Sacroiliac Joint Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	SpineCare Medical Group	Daly City	California

Sponsors (1)

Lead Sponsor	Collaborator
Zyga Technology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No