Prospective SPINE Registry

Study Overview
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Brief Summary
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This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.

Official Title
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Prospective Study on Safety and Performance of Surgalign spINE Products

Conditions
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Sacroiliac; Fusion, Sacroiliac, Joint Diseases, Musculoskeletal Diseases, Spinal Disease, Spinal Stenosis, Spinal Instability, Fusion of Joint, Fusion of Spine, Spinal Fusion, Spine

Intervention / Treatment
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* Device: RTI Spine products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for RTI spine product. Willing and able to consent to the study. Exclusion Criteria: Patient who is, or is expected to be inaccessible for follow-up. Patient meets any exclusion criteria required by local law (e.g. age, mental capacity, etc.). Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent participation or otherwise render patient ineligible for the study.

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

| Intervention/Treatment |
| --- |
|Device: RTI Spine products|Interbody fusion devices - intended to help facilitate fusion by providing a platform for bone growth, while maintaining height and decompression. Supplemental fixation and/or stabilization devices - are intended to stabilize the spine to allow for fusion to occur, maintain current spinal movement, correct deformities or curvature, treat trauma, spinal stenosis, tumor and pseudarthrosis. Bone graft substitute - is intended to aid in fusion.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Rates | Rates of reoperation and/or revision procedures at index level | 1 month, 3 months, 6 months, 12 months, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion | Fusion success measures by radiological assessment (x-ray, CT scan, MRI, etc.) | 1 month, 3 months, 6 months, 12 months, and 24 months | 
| Radiographic Findings | Change in radiographic findings | 1 month, 3 months, 6 months, 12 months, and 24 months | 
| Adverse Events | Number of procedure and device related adverse events | 1 month, 3 months, 6 months, 12 months, and 24 months | 
| Disability (Cervical) | Change in Neck Disability Index | 1 month, 3 months, 6 months, 12 months, and 24 months | 
| Disability (non-Cervical) | Change in Oswestry Disability Index | 1 month, 3 months, 6 months, 12 months, and 24 months | 
| Pain Change | Change in pain as determined by Visual Analogue Scale (VAS) | 1 month, 3 months, 6 months, 12 months, and 24 months | 
| Time to Intervention | Time to first reoperation and/or revision procedure at index leve | 1 month, 3 months, 6 months, 12 months, and 24 months |