Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
- Conditions
- Sacroiliac Joint Dysfunction
- Interventions
- Device: SImmetry
- Registration Number
- NCT02074761
- Lead Sponsor
- Surgalign Spine Technologies
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SImmetry Implant SImmetry Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant.
- Primary Outcome Measures
Name Time Method SI Joint Fusion 12 months Fusion of the SI joint at 12 and 24 months, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium. This will be assessed by an independent core laboratory
SI Joint Pain Reduction 6 Months SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.
- Secondary Outcome Measures
Name Time Method SI Joint Pain Reduction 12 months SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.
Disability 6 months Functional ability as determined by the Oswestry Disability Index
Quality of Life 6 months Quality of life as determined by EQ-5D
Trial Locations
- Locations (22)
Essentia Health
🇺🇸Duluth, Minnesota, United States
Kaiser Permanente
🇺🇸Oakland, California, United States
BASIC Spine
🇺🇸Newport Beach, California, United States
Rocky Mountain Spine Clinic
🇺🇸Lone Tree, Colorado, United States
Orthopaedic Clinic of Daytona Beach
🇺🇸Daytona Beach, Florida, United States
Central Florida Neurosurgery Institute
🇺🇸Orlando, Florida, United States
DK Orthopaedics
🇺🇸Crown Point, Indiana, United States
Flagler Hospital
🇺🇸Saint Augustine, Florida, United States
Gainesville Physical Therapy
🇺🇸Gainesville, Georgia, United States
Western Michigan University Homer Stryker MD School of Medicine
🇺🇸Kalamazoo, Michigan, United States
Tristate Brain and Spine Institute
🇺🇸Alexandria, Minnesota, United States
Regional Brain and Spine
🇺🇸Cape Girardeau, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Azalea Orthopedics
🇺🇸Tyler, Texas, United States
Bellevue Bone and Joint Physicians
🇺🇸Bellevue, Washington, United States
Black Hills Orthopedic & Spine Center
🇺🇸Rapid City, South Dakota, United States
Fourth Corner Neurological Associates
🇺🇸Bellingham, Washington, United States
Northwest Orthopaedic Specialists
🇺🇸Spokane, Washington, United States
SBA Medical Center
🇺🇸El Dorado, Kansas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Portland Pain and Spine
🇺🇸Portland, Oregon, United States
The CORE Institute
🇺🇸Phoenix, Arizona, United States