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 (0-10);~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.
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.