SI Joint Fusion and Decortication Using the SImmetry System (NCT02560714) | Clinical Trial Compass
TerminatedNot Applicable
SI Joint Fusion and Decortication Using the SImmetry System
Stopped: No additional enrollment
United States17 participantsStarted 2015-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
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 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 problem…