Sacroiliac Joint Dysfunction Clinical Trial
Official title:
Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
Verified date | October 2020 |
Source | Surgalign Spine Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.
Status | Active, not recruiting |
Enrollment | 250 |
Est. completion date | November 2020 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Tristate Brain and Spine Institute | Alexandria | Minnesota |
United States | Bellevue Bone and Joint Physicians | Bellevue | Washington |
United States | Fourth Corner Neurological Associates | Bellingham | Washington |
United States | Regional Brain and Spine | Cape Girardeau | Missouri |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | DK Orthopaedics | Crown Point | Indiana |
United States | Orthopaedic Clinic of Daytona Beach | Daytona Beach | Florida |
United States | Essentia Health | Duluth | Minnesota |
United States | SBA Medical Center | El Dorado | Kansas |
United States | Gainesville Physical Therapy | Gainesville | Georgia |
United States | Western Michigan University Homer Stryker MD School of Medicine | Kalamazoo | Michigan |
United States | Rocky Mountain Spine Clinic | Lone Tree | Colorado |
United States | BASIC Spine | Newport Beach | California |
United States | Kaiser Permanente | Oakland | California |
United States | Central Florida Neurosurgery Institute | Orlando | Florida |
United States | The CORE Institute | Phoenix | Arizona |
United States | Portland Pain and Spine | Portland | Oregon |
United States | Black Hills Orthopedic & Spine Center | Rapid City | South Dakota |
United States | Flagler Hospital | Saint Augustine | Florida |
United States | University of Utah | Salt Lake City | Utah |
United States | Northwest Orthopaedic Specialists | Spokane | Washington |
United States | Azalea Orthopedics | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Surgalign Spine Technologies |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SI Joint Fusion | 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 | 12 months | |
Primary | SI Joint Pain Reduction | SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months. | 6 Months | |
Secondary | SI Joint Pain Reduction | SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits. | 12 months | |
Secondary | Disability | Functional ability as determined by the Oswestry Disability Index | 6 months | |
Secondary | Quality of Life | Quality of life as determined by EQ-5D | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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