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History of Changes for Study: NCT01681004
Investigation of Sacroiliac Fusion Treatment (INSITE) (INSITE)
Latest version (submitted August 23, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 6, 2012 None (earliest Version on record)
2 November 27, 2012 Study Status and Contacts/Locations
3 December 17, 2012 Study Status and Contacts/Locations
4 December 21, 2012 Contacts/Locations and Study Status
5 February 7, 2013 Study Status and Contacts/Locations
6 May 10, 2013 Study Status and Contacts/Locations
7 May 14, 2013 Contacts/Locations and Study Status
8 July 17, 2013 Study Status and Contacts/Locations
9 July 22, 2013 Contacts/Locations and Study Status
10 August 1, 2013 Contacts/Locations and Study Status
11 August 21, 2013 Contacts/Locations and Study Status
12 September 11, 2013 Study Status and Eligibility
13 September 18, 2013 Contacts/Locations and Study Status
14 September 19, 2013 Contacts/Locations and Study Status
15 October 9, 2013 Contacts/Locations and Study Status
16 October 14, 2013 Contacts/Locations and Study Status
17 November 22, 2013 Contacts/Locations and Study Status
18 December 12, 2013 Study Status and Contacts/Locations
19 December 23, 2013 Contacts/Locations and Study Status
20 January 20, 2014 Study Status and Contacts/Locations
21 January 21, 2014 Contacts/Locations and Study Status
22 January 29, 2014 Contacts/Locations and Study Status
23 January 30, 2014 Contacts/Locations and Study Status
24 February 5, 2014 Contacts/Locations and Study Status
25 February 14, 2014 Contacts/Locations and Study Status
26 February 19, 2014 Contacts/Locations and Study Status
27 February 20, 2014 Contacts/Locations and Study Status
28 February 24, 2014 Contacts/Locations and Study Status
29 February 28, 2014 Contacts/Locations and Study Status
30 March 18, 2014 Study Status and Contacts/Locations
31 May 1, 2014 Recruitment Status, Contacts/Locations and Study Status
32 June 26, 2014 Study Status and Contacts/Locations
33 July 25, 2014 Study Status
34 September 22, 2014 Study Status
35 November 19, 2014 Study Status
36 December 18, 2014 Study Status and Study Design
37 February 4, 2015 Study Status
38 May 8, 2015 Study Status
39 May 11, 2015 Study Status
40 May 20, 2015 Study Status
41 June 3, 2015 Study Status
42 August 23, 2017 Recruitment Status, Study Status, Outcome Measures, Study Design, Contacts/Locations, Results, IPDSharing, References and Study Description
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Study NCT01681004
Submitted Date:  September 6, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 300103
Brief Title: Investigation of Sacroiliac Fusion Treatment (INSITE) (INSITE)
Official Title: INSITE Investigation of Sacroiliac Fusion Treatment
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2012
Overall Status: Recruiting
Study Start: September 2012
Primary Completion: October 2014 [Anticipated]
Study Completion: November 2014 [Anticipated]
First Submitted: September 1, 2012
First Submitted that
Met QC Criteria:
September 6, 2012
First Posted: September 7, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 6, 2012
Last Update Posted: September 7, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: SI-BONE, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: iFuse Implant System
Surgical placement of iFuse implants in the affected SI joint
Device: iFuse Implant System
Placement of iFuse implant system via surgery
Active Comparator: Non-Surgical Management
Medications, SI joint injection, physical therapy and RF ablation of SI joint
Non-surgical management
Medications for pain, physical therapy, SI joint injection and RF ablation
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Subject Success
[ Time Frame: 6 months ]

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.
Secondary Outcome Measures:
1. Improvement in Si joint pain
[ Time Frame: Screening, 1, 3, 6, 12, 18 and 24 months ]

Improvement in SI joint pain VAS score at post-operative visits
2. Improvement in back dysfunction
[ Time Frame: Screening, 1, 3, 6, 12 and 24 months ]

Improvement in ODI at post-operative visits
3. Improvement in quality of life
[ Time Frame: Baseline, 6, 12 and 24 months ]

Improvement in QOL as measured by SF-36 PCS and ED-5D at post-operative visits
4. Ambulatory status
[ Time Frame: Baseline, 1,3,6,12,18 and 24 months ]

Time to full ambulation amongst those without full ambulation at baseline
5. Work status
[ Time Frame: Baseline, 1,3,6,12,18 and 24 months ]

Proportion of non-working subjects who return to work
6. Serious adverse events
[ Time Frame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months ]

Any event meeting ISO14155 definition for serious adverse event at following timepoints: 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.
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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:

  • 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:
    • SI joint disruption:
      1. Asymmetric SI joint widening on X-ray or CT scan, or
      2. Leakage of contrast on diagnostic arthrography
    • Degenerative sacroiliitis:
      1. Radiographic evidence of SI joint degeneration, including sclerosis, osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or
      2. 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:
    • Sacral dysplasia
    • Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
    • Tumor
    • Infection
    • Acute fracture
    • 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
Open or close this module Contacts/Locations
Central Contact Person: Kathryn Wine, MPH
Telephone: 408-207-0700 Ext. 2215
Email: kwine@si-bone.com
Central Contact Backup: Daniel C Cher, MD
Telephone: 408-207-0700 Ext. 2233
Email: dcher@si-bone.com
Locations: United States, Missouri
HCA Midwest
[Recruiting]
Kansas City, Missouri, United States, 64132
Contact:Contact: Amy Akins, RN 816-276-9652 amy.akins@hcamidwest.com
Contact:Principal Investigator: William Rosenberg, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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