Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System



Status:Active, not recruiting
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:January 6, 2015
End Date:August 2020

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Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to
evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.

This is a prospective, non-randomized post market study designed to evaluate fusion and pain
reduction following the use of the SImmetry System. This study will be conducted at up to 40
sites and 250 total subjects will be enrolled and followed through 24 months. Data will be
collected pre-operatively, implant, and at specified follow-up time points through 24 months.

Key Inclusion Criteria:

- At least three positive provocative tests for SIJ pain

- Non-operative management of SIJ pain for ≥ 6 months prior to surgery

- At least one positive diagnostic SIJ injection resulting in a ≥ 50% decrease in pain

- VAS back pain score of ≥ 60 mm

- The subject is at least 18 years of age

Key Exclusion Criteria:

- Trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading
to a neurological deficit, or pelvic soft tissue or bony tumors

- Pregnant or is planning on becoming pregnant in the next two years

- 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.

- Receiving or seeking worker's compensation, disability remuneration, and/or involved
in litigation related to low back or SIJ pain

- History of significant emotional or psychosocial disturbance
We found this trial at
22
sites
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Erik Kubiak, MD
University of Utah Research is a major component in the life of the U benefiting...
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Alexandria, Minnesota 56308
Principal Investigator: Hamid Abbasi, MD
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Alexandria, MN
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Bellevue, Washington 98004
Principal Investigator: Christopher Boone, MD
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Bellevue, WA
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Bellingham, Washington 98225
Principal Investigator: David Baker, MD
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Cape Girardeau, Missouri 63701
Principal Investigator: Kyle Colle, DO
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Stephen Kalhorn, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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7284 West Lincoln Highway
Crown Point, Indiana 46307
Principal Investigator: Donald Kucharzyk, DO
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Crown Point, IN
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Daytona Beach, Florida 32117
Principal Investigator: Mark Gillespy, MD
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Daytona Beach, FL
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Duluth, Minnesota 55805
Principal Investigator: Jefferson Davis, DO
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Duluth, MN
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El Dorado, Kansas 67042
Principal Investigator: Gerard Librodo, MD
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El Dorado, KS
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Gainesville, Georgia 30506
Principal Investigator: Mathew Hazzard
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Gainesville, GA
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1000 Oakland Drive
Kalamazoo, Michigan 49008
Principal Investigator: Sonia Eden, MD
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Kalamazoo, MI
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10103 RidgeGate Parkway
Lone Tree, Colorado 80124
Principal Investigator: John Barker, MD
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Lone Tree, CO
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Newport Beach, California 92660
Principal Investigator: Gowriharan Thaiyananthan, MD
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Oakland, California 94612
Principal Investigator: Ravi Bains, MD
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801 North Orange Avenue
Orlando, Florida 32801
Principal Investigator: Pablo Ramirez, MD
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Orlando, FL
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Phoenix, Arizona 85023
Principal Investigator: Ali Araghi, DO
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12672 Northwest Barnes Road
Portland, Oregon 97229
Principal Investigator: Carl Balog, MD
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Rapid City, South Dakota 57702
Principal Investigator: Robert Woodruff, MD
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400 Health Park Boulevard
Saint Augustine, Florida 32086
Principal Investigator: David Greenwald, MD
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Spokane, Washington 99208
Principal Investigator: Antoine Tohmeh, MD
Phone: 509-465-1300
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Tyler, Texas 75701
Principal Investigator: Todd Raabe, MD
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Tyler, TX
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