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Investigation of Sacroiliac Fusion Treatment (INSITE) (INSITE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.
ClinicalTrials.gov Identifier:
NCT01681004
First received: September 1, 2012
Last updated: August 23, 2017
Last verified: August 2017
September 1, 2012
August 23, 2017
September 2012
February 2015   (Final data collection date for primary outcome measure)
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. 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.
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.
Complete list of historical versions of study NCT01681004 on ClinicalTrials.gov Archive Site
  • Improvement in SI Joint Pain VAS Score at 1 Month [ Time Frame: 1 month ]
    Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
  • Improvement in Si Joint Pain VAS Score at 3 Months [ Time Frame: 3 Months ]
    Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
  • Improvement in SI Joint Pain VAS Score at 6 Months [ Time Frame: 6 Months ]
    Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
  • Improvement in SI Joint Pain VAS Score at 12 Months [ Time Frame: 12 Months ]
    Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.
  • Improvement in SI Joint Pain VAS Score at 24 Months [ Time Frame: 24 Months ]
    Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.
  • Improvement in Back Dysfunction [ Time Frame: 1 month ]

    Improvement in ODI score of greater than or equal to 15 points, at month 1.

    Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Improvement in Back Dysfunction [ Time Frame: 3 Months ]

    Improvement in ODI score of greater than or equal to 15 points, at month 3.

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Improvement in Back Dysfunction [ Time Frame: 6 Months ]

    Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Improvement in Back Dysfunction [ Time Frame: 12 Months ]
    Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.
  • Improvement in Back Dysfunction [ Time Frame: 24 Months ]
    Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.
  • Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits [ Time Frame: 6 months ]

    Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits [ Time Frame: 12 Months ]

    Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits [ Time Frame: 24 months ]

    Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits [ Time Frame: 6 months ]

    Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits [ Time Frame: 12 Months ]

    Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits [ Time Frame: 24 months ]

    Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Ambulatory Status [ Time Frame: 24 months (surgical group), 6 months (non-surgical group) ]

    Time to full ambulation among those without full ambulation at baseline.

    60 days was the median of time to full ambulation for the iFuse implant System arm.

  • Work Status [ Time Frame: 1 month ]

    Proportion of non-working (due to back pain or other reasons) subjects who return to work

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Work Status [ Time Frame: 3 Months ]

    Non-working subjects (due to back pain or other reasons) who return to work

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Work Status [ Time Frame: 6 Months ]

    Non-working subjects who return to work

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Work Status [ Time Frame: 12 Months ]

    Non-working subjects who return to work

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Work Status [ Time Frame: 18 Months ]

    Non-working subjects who return to work

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Work Status [ Time Frame: 24 Months ]

    Non-working subjects who return to work

    Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.

  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months ]
    Any event meeting ISO 14155 definition for serious adverse event at following time points: 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.
  • 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
  • Improvement in Back Dysfunction [ Time Frame: Screening, 1, 3, 6, 12 and 24 months ]
    Improvement in ODI at post-operative visits
  • 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
  • Ambulatory status [ Time Frame: Baseline, 1,3,6,12,18 and 24 months ]
    Time to full ambulation amongst those without full ambulation at baseline
  • Work Status [ Time Frame: Baseline, 1,3,6,12,18 and 24 months ]
    Proportion of non-working subjects who return to work
  • 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.
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel group randomized controlled trial
Masking: None (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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
June 2017
February 2015   (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
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01681004
300103
No
Not Provided
Plan to Share IPD: Undecided
SI-BONE, Inc.
SI-BONE, Inc.
Not Provided
Principal Investigator: Daniel J Cher, MD SI-BONE
SI-BONE, Inc.
August 2017

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