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Investigation of Sacroiliac Fusion Treatment (INSITE)

This study is currently recruiting participants.
Verified March 2014 by SI-BONE, Inc.
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.
ClinicalTrials.gov Identifier:
NCT01681004
First received: September 1, 2012
Last updated: March 18, 2014
Last verified: March 2014

September 1, 2012
March 18, 2014
September 2012
October 2014   (final data collection date for primary outcome measure)
Subject Success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01681004 on ClinicalTrials.gov Archive Site
  • Improvement in Si joint pain [ Time Frame: Screening, 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    Improvement in SI joint pain VAS score at post-operative visits
  • Improvement in back dysfunction [ Time Frame: Screening, 1, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Improvement in ODI at post-operative visits
  • Improvement in quality of life [ Time Frame: Baseline, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Improvement in QOL as measured by SF-36 PCS and ED-5D at post-operative visits
  • Ambulatory status [ Time Frame: Baseline, 1,3,6,12,18 and 24 months ] [ Designated as safety issue: No ]
    Time to full ambulation amongst those without full ambulation at baseline
  • Work status [ Time Frame: Baseline, 1,3,6,12,18 and 24 months ] [ Designated as safety issue: No ]
    Proportion of non-working subjects who return to work
  • Serious adverse events [ Time Frame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Investigation of Sacroiliac Fusion Treatment (INSITE)
INSITE Investigation of Sacroiliac Fusion Treatment

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Degenerative Sacroiliitis
  • Sacroiliac Joint Disruption
  • 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
  • Experimental: iFuse Implant System
    Surgical placement of iFuse implants in the affected SI joint
    Intervention: Device: iFuse Implant System
  • Active Comparator: Non-Surgical Management
    Medications, SI joint injection, physical therapy and RF ablation of SI joint
    Intervention: Other: Non-surgical management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
November 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact: Kathryn Wine, MPH 408-207-0700 ext 2215 kwine@si-bone.com
Contact: Daniel C Cher, MD 408-207-0700 ext 2233 dcher@si-bone.com
United States
 
NCT01681004
300103
No
SI-BONE, Inc.
SI-BONE, Inc.
Not Provided
Not Provided
SI-BONE, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP