Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-26 @ 7:13 AM
Study NCT ID:
NCT05712850
Status:
UNKNOWN
Last Update Posted:
2023-07-24
First Post:
2023-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
Sponsor:
VG Innovations, LLC
Organization:
Study Overview
Official Title:
A Prospective, Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: