Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

Conditions
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Sacroiliac Joint Dysfunction

Intervention / Treatment
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* Device: SImmetry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SImmetry Implant<br>Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant. | Device: SImmetry<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 6 months | 
| Quality of Life | Quality of life as determined by EQ-5D | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SIJ, sacroiliac joint fusion, SIJ fusion, SI joint