Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712850
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-07-24
First Post:
2023-01-25
Brief Title:
Clinical Outcome and Fusion Results Using the SiJoin Transfixing Sacroiliac Fusion Device
Sponsor:
VG Innovations LLC
Organization:
VG Innovations LLC
Study Overview
Official Title:
A Prospective Single Arm Clinical Trial Evaluating Clinical Outcome and Fusion Results Using the SiJoin Transfixing Sacroiliac Fusion Device
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-07
Last Known Status:
None
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 joints 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 n25 from 1 clinical site who have been medically evaluated found appropriate for and have agreed to treatment by sacroiliac joint fixation including unilateral andor 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 fusionfixation 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 andor 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 andor other surgical technique andor 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 andor 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 PIsite or Sponsor or
15 Patient is limited or non-reader eg 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 n25 from 1 clinical site who have been medically evaluated found appropriate for and have agreed to treatment by sacroiliac joint fixation including unilateral andor 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 fusionfixation 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 andor 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 andor other surgical technique andor 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 andor 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 PIsite or Sponsor or
15 Patient is limited or non-reader eg 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:
None
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?:
None