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CompletedNCT01681004INSITEUpdated Aug 25, 2017Results posted

Investigation of Sacroiliac Fusion Treatment (INSITE)

An interventional study of iFuse Implant System and Non-surgical management in Degenerative Sacroiliitis and Sacroiliac Joint Disruption, sponsored by SI-BONE, Inc.. Completed at 19 sites in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-25.

Sponsored by SI-BONE, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Degenerative Sacroiliitis
  • Sacroiliac Joint Disruption

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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
03

In context

Sacroiliitis

42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.

This study's enrollment of 159 is above the median of 48 across 28 interventional studies indexed under Sacroiliitis.

Browse Sacroiliitis studies →

Lead sponsor

SI-BONE, Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form
  7. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion criteria

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 study or has been involved in an investigational study within 3 months prior to evaluation for participation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • Experimental
    iFuse Implant System

    Surgical placement of iFuse implants in the affected SI joint

    Device: iFuse Implant System

  • Active comparator
    Non-Surgical Management

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

    Other: Non-surgical management

Interventions

  • DeviceiFuse Implant System

    Placement of iFuse implant system via surgery

  • OtherNon-surgical management

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

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Improvement in SI Joint Pain VAS Score at 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.

    Time frame: 1 month

  2. Improvement in Si Joint Pain VAS Score at 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.

    Time frame: 3 Months

  3. Improvement in SI Joint Pain VAS Score at 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.

    Time frame: 6 Months

  4. Improvement in SI Joint Pain VAS Score at 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.

    Time frame: 12 Months

  5. Improvement in SI Joint Pain VAS Score at 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.

    Time frame: 24 Months

  6. Improvement in Back Dysfunction

    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.

    Time frame: 1 month

  7. Improvement in Back Dysfunction

    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.

    Time frame: 3 Months

  8. Improvement in Back Dysfunction

    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.

    Time frame: 6 Months

  9. Improvement in Back Dysfunction

    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.

    Time frame: 12 Months

  10. Improvement in Back Dysfunction

    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.

    Time frame: 24 Months

  11. Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits

    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.

    Time frame: 6 months

  12. Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits

    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.

    Time frame: 12 Months

  13. Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits

    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.

    Time frame: 24 months

  14. Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits

    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.

    Time frame: 6 months

  15. Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits

    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.

    Time frame: 12 Months

  16. Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits

    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.

    Time frame: 24 months

  17. Ambulatory Status

    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.

    Time frame: 24 months (surgical group), 6 months (non-surgical group)

  18. Work Status

    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.

    Time frame: 1 month

  19. Work Status

    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.

    Time frame: 3 Months

  20. Work Status

    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.

    Time frame: 6 Months

  21. Work Status

    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.

    Time frame: 12 Months

  22. Work Status

    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.

    Time frame: 18 Months

  23. Work Status

    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.

    Time frame: 24 Months

  24. Number of Participants With Serious Adverse Events (SAEs)

    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.

    Time frame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months

07

Results

Posted Aug 25, 2017
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.

Participant flow

Primary Endpoint: 6 Months
Participant flow — Primary Endpoint: 6 Months
MilestoneiFuse Implant SystemNon-Surgical Management
Started10246
Crossover to surgical treatment039
Completed10144
Not completed12
Withdrew: Withdrawal by subject12
Study Completion
Participant flow — Study Completion
MilestoneiFuse Implant SystemNon-Surgical Management
Started10144
Completed8936
Not completed128
Withdrew: Lost to follow-up83
Withdrew: Physician decision13
Withdrew: Site termination21
Withdrew: Death11

Outcome measures

PrimarySubject 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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Subject Success
ParticipantsiFuse Implant SystemNon-Surgical Management
Subject Success8412
SecondaryImprovement in SI Joint Pain VAS Score at 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.

Time frame:
1 month
Reported as:
Count of participants · Participants
Improvement in SI Joint Pain VAS Score at 1 Month
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in SI Joint Pain VAS Score at 1 Month8413
SecondaryImprovement in Si Joint Pain VAS Score at 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.

Time frame:
3 Months
Reported as:
Count of participants · Participants
Improvement in Si Joint Pain VAS Score at 3 Months
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in Si Joint Pain VAS Score at 3 Months8717
SecondaryImprovement in SI Joint Pain VAS Score at 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.

Time frame:
6 Months
Reported as:
Count of participants · Participants
Improvement in SI Joint Pain VAS Score at 6 Months
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in SI Joint Pain VAS Score at 6 Months8412
SecondaryImprovement in SI Joint Pain VAS Score at 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.

Time frame:
12 Months
Reported as:
Count of participants · Participants
Improvement in SI Joint Pain VAS Score at 12 Months
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in SI Joint Pain VAS Score at 12 Months81NA
SecondaryImprovement in SI Joint Pain VAS Score at 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.

Time frame:
24 Months
Reported as:
Count of participants · Participants
Improvement in SI Joint Pain VAS Score at 24 Months
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in SI Joint Pain VAS Score at 24 Months75NA
SecondaryImprovement in Back Dysfunction

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.

Time frame:
1 month
Reported as:
Count of participants · Participants
Improvement in Back Dysfunction
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in Back Dysfunction496
SecondaryImprovement in Back Dysfunction

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.

Time frame:
3 Months
Reported as:
Count of participants · Participants
Improvement in Back Dysfunction
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in Back Dysfunction7213
SecondaryImprovement in Back Dysfunction

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.

Time frame:
6 Months
Reported as:
Count of participants · Participants
Improvement in Back Dysfunction
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in Back Dysfunction746
SecondaryImprovement in Back Dysfunction

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.

Time frame:
12 Months
Reported as:
Count of participants · Participants
Improvement in Back Dysfunction
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in Back Dysfunction72NA
SecondaryImprovement in Back Dysfunction

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.

Time frame:
24 Months
Reported as:
Count of participants · Participants
Improvement in Back Dysfunction
ParticipantsiFuse Implant SystemNon-Surgical Management
Improvement in Back Dysfunction60NA
SecondaryImprovement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits

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.

Time frame:
6 months
Reported as:
Mean · units on a scale
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
units on a scaleiFuse Implant SystemNon-Surgical Management
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits12.5 ± 10.51.3 ± 8.2
SecondaryImprovement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits

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.

Time frame:
12 Months
Reported as:
Mean · units on a scale
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
units on a scaleiFuse Implant SystemNon-Surgical Management
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits13.0 ± 9.9NA ± NA
SecondaryImprovement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits

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.

Time frame:
24 months
Reported as:
Mean · units on a scale
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
units on a scaleiFuse Implant SystemNon-Surgical Management
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits11.2 ± 10.7NA ± NA
SecondaryImprovement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits

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.

Time frame:
6 months
Reported as:
Mean · units on a scale
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
units on a scaleiFuse Implant SystemNon-Surgical Management
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits0.29 ± 0.220.06 ± 0.28
SecondaryImprovement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits

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.

Time frame:
12 Months
Reported as:
Mean · units on a scale
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
units on a scaleiFuse Implant SystemNon-Surgical Management
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits0.31 ± 0.22NA ± NA
SecondaryImprovement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits

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.

Time frame:
24 months
Reported as:
Mean · units on a scale
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
units on a scaleiFuse Implant SystemNon-Surgical Management
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits0.29 ± 0.24NA ± NA
SecondaryAmbulatory Status

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.

Time frame:
24 months (surgical group), 6 months (non-surgical group)
Reported as:
Median · Days, median
Ambulatory Status
Days, medianiFuse Implant SystemNon-Surgical Management
Ambulatory Status60 (46 to NA)NA (NA to NA)
SecondaryWork Status

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.

Time frame:
1 month
Reported as:
Count of participants · Participants
Work Status
ParticipantsiFuse Implant SystemNon-Surgical Management
Work Status20
SecondaryWork Status

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.

Time frame:
3 Months
Reported as:
Count of participants · Participants
Work Status
ParticipantsiFuse Implant SystemNon-Surgical Management
Work Status30
SecondaryWork Status

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.

Time frame:
6 Months
Reported as:
Count of participants · Participants
Work Status
ParticipantsiFuse Implant SystemNon-Surgical Management
Work Status50
SecondaryWork Status

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.

Time frame:
12 Months
Reported as:
Count of participants · Participants
Work Status
ParticipantsiFuse Implant SystemNon-Surgical Management
Work Status4NA
SecondaryWork Status

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.

Time frame:
18 Months
Reported as:
Count of participants · Participants
Work Status
ParticipantsiFuse Implant SystemNon-Surgical Management
Work Status3NA
SecondaryWork Status

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.

Time frame:
24 Months
Reported as:
Count of participants · Participants
Work Status
ParticipantsiFuse Implant SystemNon-Surgical Management
Work Status2NA
SecondaryNumber of Participants With Serious Adverse Events (SAEs)

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.

Time frame:
Procedure, discharge, 1, 3, 6, 12, 18 and 24 months
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs)
ParticipantsiFuse Implant SystemNon-Surgical Management
Number of Participants With Serious Adverse Events (SAEs)3812

Adverse events

Collected over 1 month, 3 months, 6 months, 12 months, 18 months, 24 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
iFuse Implant System1/102 (1%)38/102 (37.3%)69/102 (67.6%)
Non-Surgical Management1/46 (2.2%)12/46 (26.1%)35/46 (76.1%)
Most frequent serious events
Showing 10 of 45
Most frequent serious events
EventiFuse Implant SystemNon-Surgical Management
Contralateral SIJ painMusculoskeletal and connective tissue disorders10/1020/46
Degenerative disease - spineMusculoskeletal and connective tissue disorders7/1021/46
Meniscal tearMusculoskeletal and connective tissue disorders4/1021/46
Back painMusculoskeletal and connective tissue disorders3/1021/46
Ankle fractureMusculoskeletal and connective tissue disorders0/1021/46
Ipsilateral - SIJ painMusculoskeletal and connective tissue disorders0/1021/46
Avascular necrosis of left hipMusculoskeletal and connective tissue disorders0/1021/46
Fracture - tibia / fibulaMusculoskeletal and connective tissue disorders0/1021/46
Knee painMusculoskeletal and connective tissue disorders0/1021/46
Snapping scapula syndromeMusculoskeletal and connective tissue disorders0/1021/46
Most frequent other events
Most frequent other events
EventiFuse Implant SystemNon-Surgical Management
Back painMusculoskeletal and connective tissue disorders27/1028/46
Degenerative disease - spineMusculoskeletal and connective tissue disorders17/10212/46
SIJ pain - ipsilateralMusculoskeletal and connective tissue disorders13/10210/46
SIJ pain - contralateralMusculoskeletal and connective tissue disorders12/1026/46
Trochanteric bursitisMusculoskeletal and connective tissue disorders12/1024/46
Leg painMusculoskeletal and connective tissue disorders0/1024/46
Upper respiratory infectionInfections and infestations5/1024/46
Shoulder painMusculoskeletal and connective tissue disorders8/1022/46
Hip painMusculoskeletal and connective tissue disorders7/1020/46
Knee painMusculoskeletal and connective tissue disorders6/1023/46

Baseline characteristics

Of the 442 patients who were screened for participation at 19 sites, 159 (37.8%) were enrolled. Eleven subjects withdrew before treatment (1 before randomization and 10 after randomization but before any treatment was performed), yielding a total of 148 subjects who were enrolled, randomized and treated (102 to iFuse Implant System \& 46 to NSM).

Age, Categorical
Age, Categorical(Participants)iFuse Implant SystemNon-Surgical ManagementTotal
<=18 years000
Between 18 and 65 years9238130
>=65 years10818
Sex: Female, Male
Sex: Female, Male(Participants)iFuse Implant SystemNon-Surgical ManagementTotal
Female7528103
Male271845
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)iFuse Implant SystemNon-Surgical ManagementTotal
White9744141
Black325
American Indian101
Other101
Ethnicity: Hispanic or Latino448
Body Mass Index, mean (range)
Body Mass Index, mean (range)(kg / m2)iFuse Implant SystemNon-Surgical ManagementTotal
Mean30.4 (16.7 to 49.5)30.6 (19.4 to 48.9)30.43 (16.7 to 49.5)
Smoking Status (n, %)
Smoking Status (n, %)(participants)iFuse Implant SystemNon-Surgical ManagementTotal
Current Smoker26329
Former Smoker301343
Never smoker463076
Ambulatory without assistance
Ambulatory without assistance(Participants)iFuse Implant SystemNon-Surgical ManagementTotal
Count of participants8941130
Work status (n, %)
Work status (n, %)(Participants)iFuse Implant SystemNon-Surgical ManagementTotal
Working full time452166
Working part time9413
Not working, student101
Not working, retired21930
Not working due to back pain20828
Not working other reason6410
Prior Lumbar fusion (n, %)
Prior Lumbar fusion (n, %)(Participants)iFuse Implant SystemNon-Surgical ManagementTotal
Count of participants411758

12 further baseline measures are reported on the registry.

08

Study locations

19 sites
  • University of California, San Diego
    La Jolla, California 92093, United States
  • BASIC Spine
    Newport Beach, California 92660, United States
  • University of Colorado Denver Health Sciences
    Denver, Colorado 80045, United States
  • Yale University School of Medicine
    New Haven, Connecticut 06510, United States
  • Orthopaedic Clinic of Daytona Beach
    Daytona Beach, Florida 32117, United States
  • Brain and Spine Center, LLC
    Panama City, Florida 32405, United States
  • Resurgen's Orthopaedics
    McDonough, Georgia 30253, United States
  • Neurosurgery Consultants/ Riverside Hospital
    Kankakee, Illinois 60901, United States
  • Orthopaedic Center of Southern Illinois
    Mount Vernon, Illinois 62864, United States
  • Community Neurosurgery Hospital
    Indianapolis, Indiana 46219, United States
  • Bluegrass Orthopaedics & Hand Care Research
    Lexington, Kentucky 40509, United States
  • Spine institute of Louisiana
    Shreveport, Louisiana 71101, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • HCA Midwest
    Kansas City, Missouri 64132, United States
  • NeuroSpine Institute, LLC
    Eugene, Oregon 97401, United States
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Midwest Orthopedic Specialty Hospital
    Franklin, Wisconsin 53132, United States
  • Aurora Bay Care Medical Center
    Green Bay, Wisconsin 54311, United States
09

References and documents

Publications

  • 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. PubMed 27652199 ↗
  • 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. PubMed 26913224 ↗
  • 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. Erratum In: Clinicoecon Outcomes Res. 2016 Jun 27;8:305. doi: 10.2147/CEOR.S107803. PubMed 26719717 ↗
  • 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. PubMed 26291338 ↗
  • 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. PubMed 25785242 ↗

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2012, a primary completion of Feb 2015 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.

Results were first posted in Aug 2017, 2 years 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2012
First posted
Sep 7, 2012
Start
Sep 2012
Primary completionActual
Feb 2015
CompletionActual
Jun 2017
Results first posted
Aug 25, 2017
Last update
Aug 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01681004
Lead sponsor
SI-BONE, Inc.
Responsible party
Sponsor
First posted
Sep 7, 2012
Start date
Sep 2012
Primary completion
Feb 2015
Completion
Jun 2017
Results posted
Aug 25, 2017
Last update
Aug 25, 2017

Study contacts

Daniel J Cher, MD
principal investigator · SI-BONE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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