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

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

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.

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:

1. 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;
2. 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:

1. Assess the ease of use of the SiJoin® Fusion System;
2. Document the occurrence of adverse events related or possibly related to the use of the SiJoin® Fusion System;
3. Document the occurrence of subsequent surgical intervention at the sacroiliac joint.

Inclusion Criteria:

Candidates must meet ALL of the following:

1. Have provided consent for research by signing the Information and Consent for Research form;
2. Have given appropriate operative consent for a sacroiliac joint fixation procedure as standard of care using the SiJoin® Transfixing Sacroiliac Fusion Device;
3. Are skeletally mature male or female, and are at least 18 years of age at time of surgery;
4. Patient history confirms sacroiliac joint disfunction;
5. Failure of six months of conservative care;
6. Failure of NSAIDs;
7. Positive diagnosis injection of sacroiliac joint; and
8. 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:

1. Previous surgery or prior hardware in place at the target sacroiliac joint;
2. Deidentified data cannot be provided;
3. If female, pregnant at time of sacroiliac joint surgery;
4. Found to be inappropriate candidate for sacroiliac joint fixation;
5. 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;
6. Has a medical disorder or is receiving medications that would be expected to interfere with osteogenesis;
7. Has active malignancy, or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years or surgery;
8. 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;
9. Has BMI >40%;
10. Has history of tobacco smoking within 6 months prior to operation;
11. 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;
12. Has history of diabetes;
13. Are participating in any other clinical trial;
14. Patient is an employee (or family members of employees) of the PI/site or Sponsor; or
15. Patient is limited or non-reader (e.g., blind, illiterate) Study Duration: 12 months

Study Outcomes:

The primary study outcomes of this study are:

1. Fusion grade at 12 months follow-up (depending on patient availability) using CT scans with a grading system based on:

   1. Complete fusion; or
   2. No fusion.

2. Subject success / Clinical outcome: Evaluate the reduction in baseline VAS back pain score at:

   1. 2-3 weeks;
   2. 3 months; and
   3. 12 months.

The secondary outcomes of this study are:

1. Surgeon opinion of "ease of use" utilizing the SiJoin® Fusion System;
2. Occurrence of adverse events related or possibly related to the use of the SiJoin® Fusion System; and
3. 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.

Inclusion Criteria:

1. Have provided consent for research by signing the Information and Consent for research form;
2. Have given appropriate operative consent for a sacroiliac joint fixation procedure as standard of care using the SiJoin® Transfixing Sacroiliac Fusion Device;
3. Are skeletally mature male or female, and are at least 18 years of age at time of surgery;
4. Patient history confirms sacroiliac joint disfunction;
5. Failure of six months of conservative care;
6. Failure of NSAIDs;
7. Positive diagnosis injection of sacroiliac joint; and
8. Agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation.

Exclusion Criteria:

1. Previous surgery or prior hardware in place at the target sacroiliac joint;
2. Deidentified data cannot be provided;
3. If female, pregnant at time of sacroiliac joint surgery;
4. Found to be inappropriate candidate for sacroiliac joint fixation;
5. 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;
6. Has a medical disorder or is receiving medications that would be expected to interfere with osteogenesis;
7. Has active malignancy, or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years or surgery;
8. 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;
9. Has BMI >40%;
10. Has history of tobacco smoking within 6 months prior to operation;
11. 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;
12. Has history of diabetes;
13. Are participating in any other clinical trial;
14. Patient is an employee (or family members of employees) of the PI/site or Sponsor; or
15. Patient is limited or non-reader (e.g., blind, illiterate)