Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System (NCT02074761) | Clinical Trial Compass
UnknownNot Applicable
Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
United States250 participantsStarted 2015-01-06
Plain-language summary
Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.
Who can participate
Age range18 Years
SexALL
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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