Clinical trial NCT01681004: Investigation of Sacroiliac Fusion Treatment (INSITE)
Official title: INSITE Investigation of Sacroiliac Fusion Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 159
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subject Success
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in SI Joint Pain VAS Score at 1 Month
timeFrame: 1 month
measure: Improvement in Si Joint Pain VAS Score at 3 Months
timeFrame: 3 Months
measure: Improvement in SI Joint Pain VAS Score at 6 Months
timeFrame: 6 Months
measure: Improvement in SI Joint Pain VAS Score at 12 Months
timeFrame: 12 Months
measure: Improvement in SI Joint Pain VAS Score at 24 Months
timeFrame: 24 Months
measure: Improvement in Back Dysfunction
timeFrame: 1 month
measure: Improvement in Back Dysfunction
timeFrame: 3 Months
measure: Improvement in Back Dysfunction
timeFrame: 6 Months
measure: Improvement in Back Dysfunction
timeFrame: 12 Months
measure: Improvement in Back Dysfunction
timeFrame: 24 Months
measure: Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
timeFrame: 6 months
measure: Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
timeFrame: 12 Months
measure: Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
timeFrame: 24 months
measure: Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
timeFrame: 6 months
measure: Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
timeFrame: 12 Months
measure: Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
timeFrame: 24 months
measure: Ambulatory Status
timeFrame: 24 months (surgical group), 6 months (non-surgical group)
measure: Work Status
timeFrame: 1 month
measure: Work Status
timeFrame: 3 Months
measure: Work Status
timeFrame: 6 Months
measure: Work Status
timeFrame: 12 Months
measure: Work Status
timeFrame: 18 Months
measure: Work Status
timeFrame: 24 Months
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Newport Beach
country: United States
facility: BASIC Spine
state: California
city: Denver
country: United States
facility: University of Colorado Denver Health Sciences
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Daytona Beach
country: United States
facility: Orthopaedic Clinic of Daytona Beach
state: Florida
city: Panama City
country: United States
facility: Brain and Spine Center, LLC
state: Florida
city: McDonough
country: United States
facility: Resurgen's Orthopaedics
state: Georgia
city: Kankakee
country: United States
facility: Neurosurgery Consultants/ Riverside Hospital
state: Illinois
city: Mount Vernon
country: United States
facility: Orthopaedic Center of Southern Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Community Neurosurgery Hospital
state: Indiana
city: Lexington
country: United States
facility: Bluegrass Orthopaedics & Hand Care Research
state: Kentucky
city: Shreveport
country: United States
facility: Spine institute of Louisiana
state: Louisiana
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: HCA Midwest
state: Missouri
city: Eugene
country: United States
facility: NeuroSpine Institute, LLC
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Franklin
country: United States
facility: Midwest Orthopedic Specialty Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora Bay Care Medical Center
state: Wisconsin
Study officials:
affiliation: SI-BONE
name: Daniel J Cher, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016 Aug 23;10:28. doi: 10.14444/3028. eCollection 2016.
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.
citation: 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.
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 Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes. Neurosurgery. 2015 Nov;77(5):674-90; discussion 690-1. doi: 10.1227/NEU.0000000000000988.
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. 2015 Mar 5;9:6. doi: 10.14444/2006. eCollection 2015.