Degenerative SacroiliitisINSITENCT01681004
Investigation of Sacroiliac Fusion Treatment (INSITE)
A study testing iFuse Implant System and Non-surgical management in people with Degenerative Sacroiliitis and Sacroiliac Joint Disruption, run by SI-BONE, Inc. at 19 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Degenerative Sacroiliitis, Sacroiliac Joint Disruption
- What is being tested?
- iFuse Implant System and Non-surgical management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 19 sitesUnited States
- Study dates
- Sep 2012to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-70 at time of screening
- Patient has lower back pain for >6 months inadequately responsive to conservative care
- 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
Show all 17Show fewer
- One or more of the following:
- SI joint disruption:
- Asymmetric SI joint widening on X-ray or CT scan, or
- Leakage of contrast on diagnostic arthrography
- 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
- Baseline Oswestry Disability Index (ODI) score of at least 30%
- Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale*
- Patient has signed study-specific informed consent form
- Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
Who cannot join
- 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**
- Other known sacroiliac pathology such as:
- Sacral dysplasia
- Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
- Tumor
- Infection
Show all 24Show fewer
- Acute fracture
- Crystal arthropathy
- History of recent (<1 year) major trauma to pelvis
- 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.
- Osteomalacia or other metabolic bone disease
- Chronic rheumatologic condition (e.g., rheumatoid arthritis)
- Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
- Chondropathy
- Known allergy to titanium or titanium alloys
- Use of medications known to have detrimental effects on bone quality and soft-tissue healing
- Prominent neurologic condition that would interfere with physical therapy
- Current local or systemic infection that raises the risk of surgery
- Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
- Currently pregnant or planning pregnancy in the next 2 years
- Patient is a prisoner or a ward of the state.
- Known or suspected drug or alcohol abuse***
- Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
- Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Orthopaedic Clinic of Daytona Beach
Daytona Beach, Florida, 32117
University of Colorado Denver Health Sciences
Denver, Colorado, 80045
NeuroSpine Institute, LLC
Eugene, Oregon, 97401
Midwest Orthopedic Specialty Hospital
Franklin, Wisconsin, 53132
Aurora Bay Care Medical Center
Green Bay, Wisconsin, 54311
Community Neurosurgery Hospital
Indianapolis, Indiana, 46219
Neurosurgery Consultants/ Riverside Hospital
Kankakee, Illinois, 60901
HCA Midwest
Kansas City, Missouri, 64132
University of California, San Diego
La Jolla, California, 92093
Bluegrass Orthopaedics & Hand Care Research
Lexington, Kentucky, 40509
Resurgen's Orthopaedics
McDonough, Georgia, 30253
University of Minnesota
Minneapolis, Minnesota, 55455
Orthopaedic Center of Southern Illinois
Mount Vernon, Illinois, 62864
Yale University School of Medicine
New Haven, Connecticut, 06510
BASIC Spine
Newport Beach, California, 92660
Brain and Spine Center, LLC
Panama City, Florida, 32405
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Spine institute of Louisiana
Shreveport, Louisiana, 71101
About this study
Official title: 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.
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.
- Being tested
- iFuse Implant System, Non-surgical management
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFuse Implant SystemDevice
Placement of iFuse implant system via surgery
Non-surgical managementOther
Medications for pain, physical therapy, SI joint injection and RF ablation
| Study group | Role | What they receive |
|---|---|---|
| iFuse Implant System | Experimental | Surgical placement of iFuse implants in the affected SI joint Receives: Device: iFuse Implant System |
| Non-Surgical Management | Active comparator | Medications, SI joint injection, physical therapy and RF ablation of SI joint Receives: Other: Non-surgical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (24)
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.
Measured: 1 month
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.
Measured: 3 Months
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.
Measured: 6 Months
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.
Measured: 12 Months
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.
Measured: 24 Months
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.
Measured: 1 month
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.
Measured: 3 Months
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.
Measured: 6 Months
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.
Measured: 12 Months
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.
Measured: 24 Months
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.
Measured: 6 months
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.
Measured: 12 Months
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.
Measured: 24 months
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.
Measured: 6 months
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.
Measured: 12 Months
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.
Measured: 24 months
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.
Measured: 24 months (surgical group), 6 months (non-surgical group)
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.
Measured: 1 month
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.
Measured: 3 Months
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.
Measured: 6 Months
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.
Measured: 12 Months
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.
Measured: 18 Months
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.
Measured: 24 Months
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.
Measured: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Degenerative SacroiliitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- SI-BONE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel J Cher, MD, Principal investigator, SI-BONE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681004
- Sponsor's protocol ID
- 300103
- Acronym
- INSITE
- Status last verified
- Aug 2017
- First submitted
- 1 Sep 2012
- Last updated
- 25 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 27652199Polly 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 26913224Cher 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.
PubMed 26719717Polly 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 26291338Whang 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSITE Investigation of Sacroiliac Fusion Treatment
- ClinicalTrials.gov ID
- NCT01681004
- Acronym / sponsor ID
- INSITE / 300103
- Keywords
- si joint, si joint pain, si joint injury, si joint treatment, si joint injections, si joint inflammation, si joint problems, si joint symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- SI-BONE, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Posted 25 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| iFuse Implant System | Experimental | Device: iFuse Implant SystemSurgical placement of iFuse implants in the affected SI joint |
| Non-Surgical Management | Active comparator | Other: Non-surgical managementMedications, SI joint injection, physical therapy and RF ablation of SI joint |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 21-70 at time of screening
- Patient has lower back pain for >6 months inadequately responsive to conservative care
- Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
- Baseline Oswestry Disability Index (ODI) score of at least 30%
- Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale*
Key exclusion criteria (24 listed)
- 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**
- Other known sacroiliac pathology such as:
- History of recent (<1 year) major trauma to pelvis
- 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.
- Osteomalacia or other metabolic bone disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iFuse Implant SystemPlacement of iFuse implant system via surgery | Device | iFuse Implant System |
| Non-surgical managementMedications for pain, physical therapy, SI joint injection and RF ablation | Other | Non-Surgical Management |
Primary outcome
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.
24 secondary outcomes
Improvement in SI Joint Pain VAS Score at 1 Month
Time frame: 1 month
Improvement in Si Joint Pain VAS Score at 3 Months
Time frame: 3 Months
Improvement in SI Joint Pain VAS Score at 6 Months
Time frame: 6 Months
Improvement in SI Joint Pain VAS Score at 12 Months
Time frame: 12 Months
Improvement in SI Joint Pain VAS Score at 24 Months
Time frame: 24 Months
Improvement in Back Dysfunction
Time frame: 1 month
Improvement in Back Dysfunction
Time frame: 3 Months
Improvement in Back Dysfunction
Time frame: 6 Months
Improvement in Back Dysfunction
Time frame: 12 Months
Improvement in Back Dysfunction
Time frame: 24 Months
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 Visits
Time frame: 12 Months
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 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
Time frame: 12 Months
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
Time frame: 24 months
Ambulatory Status
Time frame: 24 months (surgical group), 6 months (non-surgical group)
Work Status
Time frame: 1 month
Work Status
Time frame: 3 Months
Work Status
Time frame: 6 Months
Work Status
Time frame: 12 Months
Work Status
Time frame: 18 Months
Work Status
Time frame: 24 Months
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27652199Polly 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.
- Results publication: PubMed 26913224Polly 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.
- Results publication: PubMed 26719717Cher 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.
- Results publication: PubMed 26291338Polly 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.
- Results publication: PubMed 25785242Whang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Cher, MD principal investigator
SI-BONE
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iFuse Implant System and Non-surgical management in people with Degenerative Sacroiliitis and Sacroiliac Joint Disruption, run by SI-BONE, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681004, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.