clinical outcome and fusion results using the sijoin® transfixing sacroiliac fusion device

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

Summary: 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.

Eligibility criteria:
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)