Investigation of Sacroiliac Fusion Treatment (INSITE)

NCT01681004 | Completed Results

• 1 other identifier: 300103
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 19

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.

Conditions

Degenerative Sacroiliitis; Sacroiliac Joint Disruption

Keywords

si joint; si joint pain; si joint injury; si joint treatment; si joint injections; si joint inflammation; si joint problems; si joint symptoms; hypermobile si joint; si joint arthritis; si joint pain treatment; inflamed si joint; si joint sclerosis; locked si joint; si joint injuries; si joint disease; si joint infection; sacroiliac joint pelvic pain; sacroiliac joint arthritis treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Improvement in SI Joint Pain VAS Score at 1 Month

  1 month

• Improvement in Si Joint Pain VAS Score at 3 Months

  3 Months

• Improvement in SI Joint Pain VAS Score at 6 Months

  6 Months

• Improvement in SI Joint Pain VAS Score at 12 Months

  12 Months

• Improvement in SI Joint Pain VAS Score at 24 Months

  24 Months

Study Arms (2)

iFuse Implant System

EXPERIMENTAL

Surgical placement of iFuse implants in the affected SI joint

Device: iFuse Implant System

Non-Surgical Management

ACTIVE COMPARATOR

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

Other: Non-surgical management

Interventions

iFuse Implant System DEVICE

Placement of iFuse implant system via surgery

iFuse Implant System

Non-surgical management OTHER

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

Non-Surgical Management

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-70 at time of screening
• Patient has lower back pain for \>6 months inadequately responsive to conservative care
• Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
• 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
• Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and
• 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
• 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
• Baseline Oswestry Disability Index (ODI) score of at least 30%
• Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale\*

You may not qualify if:

• 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\*\*
• Other known sacroiliac pathology such as:
• Sacral dysplasia
• Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
• Tumor
• Infection
• Acute fracture
• Crystal arthropathy
• History of recent (\<1 year) major trauma to pelvis
• 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.
• Osteomalacia or other metabolic bone disease
• Chronic rheumatologic condition (e.g., rheumatoid arthritis)
• Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
• Chondropathy
• Known allergy to titanium or titanium alloys

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (19)

University of California, San Diego

La Jolla, California, 92093, United States

Location

BASIC Spine

Newport Beach, California, 92660, United States

Location

University of Colorado Denver Health Sciences

Denver, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Orthopaedic Clinic of Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

Brain and Spine Center, LLC

Panama City, Florida, 32405, United States

Location

Resurgen's Orthopaedics

McDonough, Georgia, 30253, United States

Location

Neurosurgery Consultants/ Riverside Hospital

Kankakee, Illinois, 60901, United States

Location

Orthopaedic Center of Southern Illinois

Mount Vernon, Illinois, 62864, United States

Location

Community Neurosurgery Hospital

Indianapolis, Indiana, 46219, United States

Location

Bluegrass Orthopaedics & Hand Care Research

Lexington, Kentucky, 40509, United States

Location

Spine institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

HCA Midwest

Kansas City, Missouri, 64132, United States

Location

NeuroSpine Institute, LLC

Eugene, Oregon, 97401, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Midwest Orthopedic Specialty Hospital

Franklin, Wisconsin, 53132, United States

Location

Aurora Bay Care Medical Center

Green Bay, Wisconsin, 54311, United States

Location

Related Publications (5)

• 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.

  PMID: 27652199 RESULT

• 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.

  PMID: 26913224 RESULT

• 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.

  PMID: 26719717 RESULT

• 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.

  PMID: 26291338 RESULT

• 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.

  PMID: 25785242 RESULT

Limitations and Caveats

Open-label (non-blinded) study. Most (\>90%) NSM subjects with continued pain crossed over after the 6-month visit. Analysis across groups after 6 months is therefore biased, since surgery by definition is not a component of non-surgical treatment.

Results Point of Contact

• Title: Daniel Cher, Vice President of Clinical Affairs
• Organization: SI-BONE, Inc.

dcher@si-bone.com

408-207-0700

Study Officials

• Daniel J Cher, MD

  SI-BONE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel group randomized controlled trial

Study Record Dates

• First Submitted: September 1, 2012
• First Posted: September 7, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2017
• Last Updated: August 25, 2017
• Results First Posted: August 25, 2017

Record last verified: 2017-08

Locations

US (19)