Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device

Study Overview
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Brief Summary
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The purpose of this clinical study is to evaluate fusion of the SI joint(s) and any reduction in VAS pain scores in a prospective cohort of patients utilizing the SiJoin® Transfixing Sacroiliac Fusion Device in patients that received sacroiliac fusion, without ancillary stabilization devices.

Detailed Description
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Study Title: A prospective, single arm clinical trial evaluating clinical outcome and fusion results using the SiJoin® Transfixing Sacroiliac Fusion Device Instrumentation SiJoin® Transfixing Sacroiliac Fusion Device Study Design: Non-randomized, prospective, single arm, single center clinical trial Patient Population and Sample Size: Patients (n≥25) from 1 clinical site, who have been medically evaluated, found appropriate for, and have agreed to treatment by sacroiliac joint fixation, including unilateral and/or bilateral sacroiliac fusion according to accepted medical standards using the SiJoin® Transfixing Sacroiliac Fusion Device. Objectives: The primary objective of this study is: Evaluate the fusion status of sacroiliac joints at 12 months (depending on patient (vailability) following joint fusion/fixation using the SiJoin® Transfixing Sacroiliac Fusion Device; Subject success / Clinical outcome: Evaluate the reduction in baseline VAS back pain score at 2-3 weeks, 3 months, and 12 months. The secondary objectives of this study are to: Assess the ease of use of the SiJoin® Fusion System; Document the occurrence of adverse events related or possibly related to the use of the SiJoin® Fusion System; Document the occurrence of subsequent surgical intervention at the sacroiliac joint. Inclusion Criteria: Candidates must meet ALL of the following: Have provided consent for research by signing the Information and Consent for Research form; Have given appropriate operative consent for a sacroiliac joint fixation procedure as standard of care using the SiJoin® Transfixing Sacroiliac Fusion Device; Are skeletally mature male or female, and are at least 18 years of age at time of surgery; Patient history confirms sacroiliac joint disfunction; Failure of six months of conservative care; Failure of NSAIDs; Positive diagnosis injection of sacroiliac joint; and Agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation. Exclusion Criteria: Candidates will be excluded if they have ANY of the following: Previous surgery or prior hardware in place at the target sacroiliac joint; Deidentified data cannot be provided; If female, pregnant at time of sacroiliac joint surgery; Found to be inappropriate candidate for sacroiliac joint fixation; Requires additional and/or other surgical technique and/or approach to the sacroiliac joint, which may in the opinion of the Primary Investigator confound measurement of outcome variables; Has a medical disorder or is receiving medications that would be expected to interfere with osteogenesis; Has active malignancy, or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years or surgery; Has active local or systemic infection or history of local or systemic infection, immune-deficiency, uncontrolled medical conditions, which in the opinion of the Investigator may increase patient risk or confound fusion results; Has BMI >40%; Has history of tobacco smoking within 6 months prior to operation; Has history of alcoholism, medication or drug abuse, psychosis, is a prisoner, and/or has a personality disorder, poor motivation, emotional or intellectual issues that would likely make the patient unreliable for participation in the study; Has history of diabetes; Are participating in any other clinical trial; Patient is an employee (or family members of employees) of the PI/site or Sponsor; or Patient is limited or non-reader (e.g., blind, illiterate) Study Duration: 12 months Study Outcomes: The primary study outcomes of this study are: Fusion grade at 12 months follow-up (depending on patient availability) using CT scans with a grading system based on: Complete fusion; or No fusion. Subject success / Clinical outcome: Evaluate the reduction in baseline VAS back pain score at: 2-3 weeks; 3 months; and 12 months. The secondary outcomes of this study are: Surgeon opinion of ease of use utilizing the SiJoin® Fusion System; Occurrence of adverse events related or possibly related to the use of the SiJoin® Fusion System; and Occurrence of subsequent surgical intervention at the target joint. Study Assessments Intraoperative: Post-placement radiograph; 12 month: sacroiliac joint CT scan; Patient provided VAS pain scores at pre-op, and each subsequent follow-up appointment.

Official Title
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A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device

Conditions
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Sacroiliitis, Sacroiliac Joint Dysfunction, Iatrogenic Injury, Osteitis Condensans Ilii, Pelvic Fracture

Intervention / Treatment
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* Procedure: SiJoin® Transfixing Sacroiliac Fusion Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have provided consent for research by signing the Information and Consent for research form; Have given appropriate operative consent for a sacroiliac joint fixation procedure as standard of care using the SiJoin® Transfixing Sacroiliac Fusion Device; Are skeletally mature male or female, and are at least 18 years of age at time of surgery; Patient history confirms sacroiliac joint disfunction; Failure of six months of conservative care; Failure of NSAIDs; Positive diagnosis injection of sacroiliac joint; and Agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation. Exclusion Criteria: Previous surgery or prior hardware in place at the target sacroiliac joint; Deidentified data cannot be provided; If female, pregnant at time of sacroiliac joint surgery; Found to be inappropriate candidate for sacroiliac joint fixation; Requires additional and/or other surgical technique and/or approach to the sacroiliac joint, which may in the opinion of the Primary Investigator confound measurement of outcome variables; Has a medical disorder or is receiving medications that would be expected to interfere with osteogenesis; Has active malignancy, or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years or surgery; Has active local or systemic infection or history of local or systemic infection, immune-deficiency, uncontrolled medical conditions, which in the opinion of the Investigator may increase patient risk or confound fusion results; Has BMI >40%; Has history of tobacco smoking within 6 months prior to operation; Has history of alcoholism, medication or drug abuse, psychosis, is a prisoner, and/or has a personality disorder, poor motivation, emotional or intellectual issues that would likely make the patient unreliable for participation in the study; Has history of diabetes; Are participating in any other clinical trial; Patient is an employee (or family members of employees) of the PI/site or Sponsor; or Patient is limited or non-reader (e.g., blind, illiterate)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: SiJoin® Transfixing Sacroiliac Fusion Device|Sacroiliac Fusion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Status/Evaluation | Evaluate the fusion status of SI Joints using CT scans with a grading system based on: Complete fusion; or No fusion. | 12 Months | 
| Visual Analog Scale (VAS) Reduction | Scale: 0 (No Pain) - 10 (Worst Pain Possible) Composite endpoint of reduction from baseline in VAS back pain score by at least 2 points. | 2-3 weeks, 3 Months, 6 Months, 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use | Assess the ease of use of the SiJoin® Fusion System Scale: 0 (Easy) - 10 (Extremely Difficult) | 12 months | 
| Adverse Avents | Monitor the occurrence of adverse events related or possibly related to the use of the SiJoin® Fusion System; | 12 months | 
| Subsequent Surgical Interventions | Monitor the occurrence of subsequent surgical intervention at the target sacroiliac joint(s). | 12 months |