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 range18 Years – 85 Years
SexALL
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Inclusion criteria
âś“. 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;
âś“. Are skeletally mature male or female, and are at least 18 years of age at time of surgery;
âś“. Patient history confirms sacroiliac joint disfunction;
âś“. Failure of six months of conservative care;
âś“. Failure of NSAIDs;
âś“. Positive diagnosis injection of sacroiliac joint; and
âś“. Agree to adhere to post-surgical medically prescribed activity limitations and/or physical rehabilitation.
Exclusion criteria
âś•. Previous surgery or prior hardware in place at the target sacroiliac joint;
âś•. Deidentified data cannot be provided;
âś•. If female, pregnant at time of sacroiliac joint surgery;
âś•. Found to be inappropriate candidate for sacroiliac joint fixation;
âś•. 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;
âś•. Has a medical disorder or is receiving medications that would be expected to interfere with osteogenesis;
âś•. Has active malignancy, or patient with a history of any malignancy (except non-melanoma skin cancer) with recurrence within 5 years or surgery;
âś•. 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;