Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT05712850
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05712850
Study Brief:
Protocol Section:
NCT05712850