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Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SImmetry Implant | Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SImmetry | Device | The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, providing stability for intra-articular fusion. The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Disability | Functional ability as determined by the Oswestry Disability Index |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and representing candidates for SIJ fusion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The CORE Institute | Phoenix | Arizona | 85023 | United States | ||
| BASIC Spine |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 2, 2023 | |
| Reset | Jan 24, 2024 |
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|
| 6 months |
| Quality of Life | Quality of life as determined by EQ-5D | 6 months |
| Newport Beach |
| California |
| 92660 |
| United States |
| Kaiser Permanente | Oakland | California | 94611 | United States |
| Rocky Mountain Spine Clinic | Lone Tree | Colorado | 80124 | United States |
| Orthopaedic Clinic of Daytona Beach | Daytona Beach | Florida | 32117 | United States |
| Central Florida Neurosurgery Institute | Orlando | Florida | 32801 | United States |
| Flagler Hospital | Saint Augustine | Florida | 32086 | United States |
| Gainesville Physical Therapy | Gainesville | Georgia | 30506 | United States |
| DK Orthopaedics | Crown Point | Indiana | 46307 | United States |
| SBA Medical Center | El Dorado | Kansas | 67042 | United States |
| Western Michigan University Homer Stryker MD School of Medicine | Kalamazoo | Michigan | 49008 | United States |
| Tristate Brain and Spine Institute | Alexandria | Minnesota | 56308 | United States |
| Essentia Health | Duluth | Minnesota | 55805 | United States |
| Regional Brain and Spine | Cape Girardeau | Missouri | 63701 | United States |
| Portland Pain and Spine | Portland | Oregon | 97229 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Black Hills Orthopedic & Spine Center | Rapid City | South Dakota | 57702 | United States |
| Azalea Orthopedics | Tyler | Texas | 75701 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| Bellevue Bone and Joint Physicians | Bellevue | Washington | 98004 | United States |
| Fourth Corner Neurological Associates | Bellingham | Washington | 98225 | United States |
| Northwest Orthopaedic Specialists | Spokane | Washington | 99208 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 2, 2023 | Jan 24, 2024 |