Investigation of Sacroiliac Fusion Treatment (INSITE)

Sacroiliac Joint Disruption Clinical Trial

— INSITE  

Official title:

INSITE Investigation of Sacroiliac Fusion Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681004
• Other study ID #: 300103
• Status: Completed
• Phase: N/A
• First received: September 1, 2012
• Last updated: August 23, 2017
• Start date: September 2012
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: SI-BONE, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo specific, targeted non-surgical treatment of the SI joint.

Description:

The intended analysis was to examine differences in responses at 6 months. It was acknowledged that subjects with chronic pain in the NSM arm group might not experience any benefit as there was little evidence at the time that NSM was helpful. The protocol included optional crossover to other treatments, including surgical treatment. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 2017
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age 21-70 at time of screening

2. Patient has lower back pain for >6 months inadequately responsive to conservative care

3. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:

1. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and

2. Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and

3. Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) (see Section 3.6.4), and

4. One or more of the following:

i. SI joint disruption:

• Asymmetric SI joint widening on X-ray or CT scan, or

• Leakage of contrast on diagnostic arthrography

ii. Degenerative sacroiliitis:

• Radiographic evidence of SI joint degeneration, including sclerosis, osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or

• Due to prior lumbosacral spine fusion

4. Baseline Oswestry Disability Index (ODI) score of at least 30%

5. Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale*

6. Patient has signed study-specific informed consent form

7. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion Criteria:

1. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture**

2. Other known sacroiliac pathology such as:

1. Sacral dysplasia

2. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)

3. Tumor

4. Infection

5. Acute fracture

6. Crystal arthropathy

3. History of recent (<1 year) major trauma to pelvis

4. Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture). Patients meeting the osteoporosis screening criteria identified by the National Osteoporosis Foundation should be screened for osteoporosis with DEXA.**** See Section 3.6.4.

5. Osteomalacia or other metabolic bone disease

6. Chronic rheumatologic condition (e.g., rheumatoid arthritis)

7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible

8. Chondropathy

9. Known allergy to titanium or titanium alloys

10. Use of medications known to have detrimental effects on bone quality and soft-tissue healing

11. Prominent neurologic condition that would interfere with physical therapy

12. Current local or systemic infection that raises the risk of surgery

13. Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.

14. Currently pregnant or planning pregnancy in the next 2 years

15. Patient is a prisoner or a ward of the state.

16. Known or suspected drug or alcohol abuse***

17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation

18. Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation

Related Conditions & MeSH terms

• Degenerative Sacroiliitis
• Sacroiliac Joint Disruption
• Sacroiliitis

Intervention

Device:
• iFuse Implant System
Placement of iFuse implant system via surgery

Other:
• Non-surgical management
Medications for pain, physical therapy, SI joint injection and RF ablation

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Orthopaedic Clinic of Daytona Beach	Daytona Beach	Florida
United States	University of Colorado Denver Health Sciences	Denver	Colorado
United States	NeuroSpine Institute, LLC	Eugene	Oregon
United States	Midwest Orthopedic Specialty Hospital	Franklin	Wisconsin
United States	Aurora Bay Care Medical Center	Green Bay	Wisconsin
United States	Community Neurosurgery Hospital	Indianapolis	Indiana
United States	Neurosurgery Consultants/ Riverside Hospital	Kankakee	Illinois
United States	HCA Midwest	Kansas City	Missouri
United States	University of California, San Diego	La Jolla	California
United States	Bluegrass Orthopaedics & Hand Care Research	Lexington	Kentucky
United States	Resurgen's Orthopaedics	McDonough	Georgia
United States	University of Minnesota	Minneapolis	Minnesota
United States	Orthopaedic Center of Southern Illinois	Mount Vernon	Illinois
United States	Yale University School of Medicine	New Haven	Connecticut
United States	BASIC Spine	Newport Beach	California
United States	Brain and Spine Center, LLC	Panama City	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Spine institute of Louisiana	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
SI-BONE, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

Cher DJ, Frasco MA, Arnold RJ, Polly DW. Cost-effectiveness of minimally invasive sacroiliac joint fusion. Clinicoecon Outcomes Res. 2015 Dec 18;8:1-14. doi: 10.2147/CEOR.S94266. eCollection 2016. Erratum in: Clinicoecon Outcomes Res. 2016;8:305. — View Citation

Polly D, Cher D, Whang PG, Frank C, Sembrano J; INSITE Study Group. Does Level of Response to SI Joint Block Predict Response to SI Joint Fusion? Int J Spine Surg. 2016 Jan 21;10:4. doi: 10.14444/3004. eCollection 2016. — View Citation

Polly DW, Cher DJ, Wine KD, Whang PG, Frank CJ, Harvey CF, Lockstadt H, Glaser JA, Limoni RP, Sembrano JN; INSITE Study Group. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Mana — View Citation

Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN; INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroilia — View Citation

Whang P, Cher D, Polly D, Frank C, Lockstadt H, Glaser J, Limoni R, Sembrano J. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. Int J Spine Surg. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Success	Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is **intent to treat**, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.	6 months
Secondary	Improvement in SI Joint Pain VAS Score at 1 Month	Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	1 month
Secondary	Improvement in Si Joint Pain VAS Score at 3 Months	Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	3 Months
Secondary	Improvement in SI Joint Pain VAS Score at 6 Months	Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	6 Months
Secondary	Improvement in SI Joint Pain VAS Score at 12 Months	Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.	12 Months
Secondary	Improvement in SI Joint Pain VAS Score at 24 Months	Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.	24 Months
Secondary	Improvement in Back Dysfunction	Improvement in ODI score of greater than or equal to 15 points, at month 1.; Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	1 month
Secondary	Improvement in Back Dysfunction	Improvement in ODI score of greater than or equal to 15 points, at month 3.; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	3 Months
Secondary	Improvement in Back Dysfunction	Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	6 Months
Secondary	Improvement in Back Dysfunction	Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.	12 Months
Secondary	Improvement in Back Dysfunction	Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.	24 Months
Secondary	Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits	Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	6 months
Secondary	Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits	Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	12 Months
Secondary	Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits	Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	24 months
Secondary	Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits	Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	6 months
Secondary	Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits	Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	12 Months
Secondary	Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits	Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	24 months
Secondary	Ambulatory Status	Time to full ambulation among those without full ambulation at baseline.; 60 days was the median of time to full ambulation for the iFuse implant System arm.	24 months (surgical group), 6 months (non-surgical group)
Secondary	Work Status	Proportion of non-working (due to back pain or other reasons) subjects who return to work; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	1 month
Secondary	Work Status	Non-working subjects (due to back pain or other reasons) who return to work; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	3 Months
Secondary	Work Status	Non-working subjects who return to work; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	6 Months
Secondary	Work Status	Non-working subjects who return to work; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	12 Months
Secondary	Work Status	Non-working subjects who return to work; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	18 Months
Secondary	Work Status	Non-working subjects who return to work; Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.	24 Months
Secondary	Number of Participants With Serious Adverse Events (SAEs)	Any event meeting ISO 14155 definition for serious adverse event at following time points: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.	Procedure, discharge, 1, 3, 6, 12, 18 and 24 months