Investigation of Sacroiliac Fusion Treatment (INSITE)

NCT ID: NCT01681004

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-06-30

Brief 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.

Detailed 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.

Conditions

Degenerative Sacroiliitis; Sacroiliac Joint Disruption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iFuse Implant System

Surgical placement of iFuse implants in the affected SI joint

Group Type: EXPERIMENTAL

iFuse Implant System

Intervention Type: DEVICE

Placement of iFuse implant system via surgery

Non-Surgical Management

Medications, SI joint injection, physical therapy and RF ablation of SI joint

Group Type: ACTIVE_COMPARATOR

Non-surgical management

Intervention Type: OTHER

Medications for pain, physical therapy, SI joint injection and RF ablation

Interventions

iFuse Implant System

Placement of iFuse implant system via surgery

Intervention Type: DEVICE

Non-surgical management

Medications for pain, physical therapy, SI joint injection and RF ablation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SI-BONE, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel J Cher, MD

Role: PRINCIPAL_INVESTIGATOR

SI-BONE

Locations

University of California, San Diego

La Jolla, California, United States

BASIC Spine

Newport Beach, California, United States

University of Colorado Denver Health Sciences

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Orthopaedic Clinic of Daytona Beach

Daytona Beach, Florida, United States

Brain and Spine Center, LLC

Panama City, Florida, United States

Resurgen's Orthopaedics

McDonough, Georgia, United States

Neurosurgery Consultants/ Riverside Hospital

Kankakee, Illinois, United States

Orthopaedic Center of Southern Illinois

Mount Vernon, Illinois, United States

Community Neurosurgery Hospital

Indianapolis, Indiana, United States

Bluegrass Orthopaedics & Hand Care Research

Lexington, Kentucky, United States

Spine institute of Louisiana

Shreveport, Louisiana, United States

University of Minnesota

Minneapolis, Minnesota, United States

HCA Midwest

Kansas City, Missouri, United States

NeuroSpine Institute, LLC

Eugene, Oregon, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Midwest Orthopedic Specialty Hospital

Franklin, Wisconsin, United States

Aurora Bay Care Medical Center

Green Bay, Wisconsin, United States

Countries

United States

References

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 Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016 Aug 23;10:28. doi: 10.14444/3028. eCollection 2016.

Reference Type: RESULT

PMID: 27652199 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26913224 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26719717 (View on PubMed)

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 Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes. Neurosurgery. 2015 Nov;77(5):674-90; discussion 690-1. doi: 10.1227/NEU.0000000000000988.

Reference Type: RESULT

PMID: 26291338 (View on PubMed)

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. 2015 Mar 5;9:6. doi: 10.14444/2006. eCollection 2015.

Reference Type: RESULT

PMID: 25785242 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

300103

Identifier Type: -

Identifier Source: org_study_id