SI Joint Fusion and Decortication Using the SImmetry System

Stopped early

Conditions studied: Sacroiliac Joint Dysfunction

In brief

The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief of SI joint pain symptoms.

Key facts

Study ID

NCT02560714

Run by

Zyga Technology, Inc.

People needed

17

Starts

2015-08-01

Expected to finish

2017-12-01

Last updated by the study team

2017-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling
• Subject has two (2) 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 two (2) diagnostic SIJ injection at least one (1) resulting in a ≥50% decrease in pain in the joint(s) from the anesthetic portion of the injection
• The subject has VAS back pain score of ≥ 50 mm
• The subject is at least 18 years of age and skeletally mature
• The subject agrees and is able to comply with study requirements

You may not qualify if…

• 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 indicated for or awaiting other spine surgery
• The subject is pregnant or is planning on becoming pregnant in the next two years
• The subject has uncontrolled insulin dependent diabetes mellitus (Type 1 Diabetes)
• The subject has chemical dependency abuse problems as evidenced by a history of abusing drugs which is documented in their past medical history or is elicited from an interview
• The subject is receiving or seeking worker's compensation, disability remuneration, and/or involved in litigation related to low back or SIJ pain
• The subject has a history of significant emotional or psychosocial disturbance (untreated or uncontrolled anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview

Where it is running

• Reno Orthaepedic Clinic — Reno, Nevada, United States

Full record on ClinicalTrials.gov

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