NCT05712850

Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device

A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: VG Innovations, LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

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: 1. 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; 2. 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: 1. Assess the ease of use of the SiJoin® Fusion System; 2. Document the occurrence of adverse events related or possibly related to the use of the SiJoin® Fusion System; 3. Document the occurrence of subsequent surgical intervention at the sacroiliac joint. Inclusion Criteria: Candidates must meet ALL of the following: 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: Candidates will be excluded if they have ANY of the following: 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) Study Duration: 12 months Study Outcomes: The primary study outcomes of this study are: 1. Fusion grade at 12 months follow-up (depending on patient availability) using CT scans with a grading system based on: 1. Complete fusion; or 2. No fusion. 2. Subject success / Clinical outcome: Evaluate the reduction in baseline VAS back pain score at: 1. 2-3 weeks; 2. 3 months; and 3. 12 months. The secondary outcomes of this study are: 1. Surgeon opinion of "ease of use" utilizing the SiJoin® Fusion System; 2. Occurrence of adverse events related or possibly related to the use of the SiJoin® Fusion System; and 3. 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.

Conditions

• Sacroiliitis
• Sacroiliac Joint Dysfunction
• Iatrogenic Injury
• Osteitis Condensans Ilii
• Pelvic Fracture

Interventions

Type	Name	Description
PROCEDURE	SiJoin® Transfixing Sacroiliac Fusion Device	Sacroiliac Fusion

Timeline

• Start date: 2023-01-19
• Primary completion: 2024-01-18
• Completion: 2025-03-31
• First posted: 2023-02-06
• Last updated: 2023-07-24

Locations

1 site across 1 country: United States