EVoluSIon

Overview

Status: Active, not recruiting
Keywords: SI Joint , Fusion , Sacroiliac Joint
IRB Number: 00073013
Specialty: Orthopaedic Surgery, Orthopaedic Surgery
Sub Specialties: Orthopaedic Trauma

Brief Summary

This study is designed to collect data from the use of the Zyga SImmetry Sacroiliac Joint Fusion System. Data related to confirmed fusion and SIJ pain reduction will be collected to evaluate clinical performance.

Principal Investigator: Erik Kubiak
Department: Orthopedic Surgery
Co Investigator:

Contact Information

Name:Mikayla Lyman
Phone: 801-583-3366
Email: mikayla.lyman@hsc.utah.edu

Inclusion Criteria

  • The subject has three (3) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen’s.
  • The 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) positive diagnostic SIJ injections, fluoroscopically guided, with two different local anesthetics.  The first injection using a numbing agent (e.g. lidocaine) and the second injection using a different numbing agent (e.g. Bupivicaine) must both must result in a ≥75% 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

  • The subject has bi-lateral SIJ disease.
  • 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 has painful hip and/or knee arthrosis with potential progression to hip and/or knee arthroplasty.
  • 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 is a smoker.
  • 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 (anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview.