Clinical trial NCT02560714: SI Joint Fusion and Decortication Using the SImmetry System
Official title: SI Joint Fusion and Decortication Using the SImmetry System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sacroiliac Joint Dysfunction
Keywords: sacroiliac joint fusion
SIJ Fusion
SI Joint
SIJ
Lead sponsor: Zyga Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and candidates for SIJ fusion.

Brief 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.

Detailed description: This is a prospective, non-randomized post market study designed to collect data on SI joint fusion and subject back pain following implant of the SImmetry device. The study will be conducted at a single site and 25 subjects will be implanted and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.

Eligibility criteria: 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 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

Primary outcomes:
measure: SI Joint Fusion
timeFrame: 24 months
measure: SI Joint Pain Reduction
timeFrame: 6 months
Secondary outcomes:
measure: SI Joint Pain Reduction
timeFrame: 24 Months
Other outcomes:
Locations:
city: Reno
country: United States
facility: Reno Orthaepedic Clinic
state: Nevada
Study officials:
References: