Sacroiliac Joint Dysfunction Clinical Trial
Official title:
A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
Verified date | July 2023 |
Source | VG Innovations, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 25 |
Est. completion date | March 31, 2025 |
Est. primary completion date | January 18, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Seaside Surgery Center | Naples | Florida |
Lead Sponsor | Collaborator |
---|---|
VG Innovations, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fusion Status/Evaluation | Evaluate the fusion status of SI Joints using CT scans with a grading system based on:
Complete fusion; or No fusion. |
12 Months | |
Primary | Visual Analog Scale (VAS) Reduction | Scale: 0 (No Pain) - 10 (Worst Pain Possible)
Composite endpoint of reduction from baseline in VAS back pain score by at least 2 points. |
2-3 weeks, 3 Months, 6 Months, 12 Months | |
Secondary | Ease of Use | Assess the ease of use of the SiJoin® Fusion System
Scale: 0 (Easy) - 10 (Extremely Difficult) |
12 months | |
Secondary | Adverse Avents | Monitor the occurrence of adverse events related or possibly related to the use of the SiJoin® Fusion System; | 12 months | |
Secondary | Subsequent Surgical Interventions | Monitor the occurrence of subsequent surgical intervention at the target sacroiliac joint(s). | 12 months |
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