Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device (NCT05712850) | Clinical Trial Compass
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Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
United States25 participantsStarted 2023-01-19
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;