Clinical trial NCT02074761: Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
Official title: Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sacroiliac Joint Dysfunction
Keywords: sacroiliac joint fusion
SIJ fusion
SI joint
SIJ
Lead sponsor: Surgalign Spine Technologies
Sponsor class: INDUSTRY
First posted: 2014-02-28
Enrollment: 250
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 representing candidates for SIJ fusion.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: SI Joint Fusion
timeFrame: 12 months
measure: SI Joint Pain Reduction
timeFrame: 6 Months
Secondary outcomes:
measure: SI Joint Pain Reduction
timeFrame: 12 months
measure: Disability
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The CORE Institute
state: Arizona
city: Newport Beach
country: United States
facility: BASIC Spine
state: California
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Spine Clinic
state: Colorado
city: Daytona Beach
country: United States
facility: Orthopaedic Clinic of Daytona Beach
state: Florida
city: Orlando
country: United States
facility: Central Florida Neurosurgery Institute
state: Florida
city: Saint Augustine
country: United States
facility: Flagler Hospital
state: Florida
city: Gainesville
country: United States
facility: Gainesville Physical Therapy
state: Georgia
city: Crown Point
country: United States
facility: DK Orthopaedics
state: Indiana
city: El Dorado
country: United States
facility: SBA Medical Center
state: Kansas
city: Kalamazoo
country: United States
facility: Western Michigan University Homer Stryker MD School of Medicine
state: Michigan
city: Alexandria
country: United States
facility: Tristate Brain and Spine Institute
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
city: Cape Girardeau
country: United States
facility: Regional Brain and Spine
state: Missouri
city: Portland
country: United States
facility: Portland Pain and Spine
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Orthopedic & Spine Center
state: South Dakota
city: Tyler
country: United States
facility: Azalea Orthopedics
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Bellevue
country: United States
facility: Bellevue Bone and Joint Physicians
state: Washington
city: Bellingham
country: United States
facility: Fourth Corner Neurological Associates
state: Washington
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists
state: Washington
Study officials:
References: