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Investigation of Sacroiliac Fusion Treatment (INSITE) (INSITE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681004
First Posted: September 7, 2012
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SI-BONE, Inc.
Results First Submitted: June 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Degenerative Sacroiliitis
Sacroiliac Joint Disruption
Interventions: Device: iFuse Implant System
Other: Non-surgical management

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
iFuse Implant System

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

Non-Surgical Management

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

Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation.

Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.


Participant Flow for 2 periods

Period 1:   Primary Endpoint: 6 Months
    iFuse Implant System   Non-Surgical Management
STARTED   102   46 
Crossover to Surgical Treatment   0   39 [1] 
COMPLETED   101   44 
NOT COMPLETED   1   2 
Withdrawal by Subject                1                2 
[1] Crossover to surgical treatment allowed per study protocol after the 6-month visit was complete.

Period 2:   Study Completion
    iFuse Implant System   Non-Surgical Management
STARTED   101   44 
COMPLETED   89   36 
NOT COMPLETED   12   8 
Lost to Follow-up                8                3 
Physician Decision                1                3 
Site Termination                2                1 
Death                1                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
iFuse Implant System

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

Non-Surgical Management

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

Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation

Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.

Total Total of all reporting groups

Baseline Measures
   iFuse Implant System   Non-Surgical Management   Total 
Overall Participants Analyzed 
[Units: Participants]
 102   46   148 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      92  90.2%      38  82.6%      130  87.8% 
>=65 years      10   9.8%      8  17.4%      18  12.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      75  73.5%      28  60.9%      103  69.6% 
Male      27  26.5%      18  39.1%      45  30.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   97   44   141 
Black   3   2   5 
American Indian   1   0   1 
Other   1   0   1 
Ethnicity: Hispanic or Latino   4   4   8 
Body Mass Index, mean (range) 
[Units: Kg / m2]
Mean (Full Range)
 30.4 
 (16.7 to 49.5) 
 30.6 
 (19.4 to 48.9) 
 30.43 
 (16.7 to 49.5) 
Smoking Status (n, %) 
[Units: Participants]
     
Current Smoker   26   3   29 
Former Smoker   30   13   43 
Never smoker   46   30   76 
Ambulatory without assistance 
[Units: Participants]
Count of Participants
 89   41   130 
Work status (n, %) 
[Units: Participants]
Count of Participants
     
Working full time   45   21   66 
Working part time   9   4   13 
Not working, student   1   0   1 
Not working, retired   21   9   30 
Not working due to back pain   20   8   28 
Not working other reason   6   4   10 
Prior Lumbar fusion (n, %) 
[Units: Participants]
Count of Participants
 41   17   58 
Underlying diagnosis 
[Units: Participants]
Count of Participants
     
Degenerative sacroiliitis   88   40   128 
Sacroiliac joint disruption   14   6   20 
Years of pain, mean (range) 
[Units: Years]
Mean (Full Range)
 7.0 
 (0.5 to 40.7) 
 5.0 
 (0.5 to 38.9) 
 6.0 
 (0.5 to 40.7) 
Pain Syndrome 
[Units: Participants]
Count of Participants
     
Pain began peripartum   29   19   48 
Pain radiates down leg   89   41   130 
Groin pain   60   29   89 
Pain worse with sitting   89   41   130 
Pain worse with rising   88   41   129 
Pain worse with walking   87   42   129 
Pain worse with climbing stairs   93   41   134 
Pain worse with descending stairs   82   37   119 
Prior treatments 
[Units: Participants]
Count of Participants
     
Physical therapy   71   36   107 
Steroid SIJ injection   85   42   127 
RF ablation   21   4   25 
Taking opiods 
[Units: Participants]
Count of Participants
 70   29   99 
Participants with lumbar stenosis 
[Units: Participants]
Count of Participants
 15   7   22 
Participants with hip diagnosis (n, %) 
[Units: Participants]
Count of Participants
 16   3   19 
Participants with sacral trauma (n, %) 
[Units: Participants]
Count of Participants
 8   3   11 
VAS SIJ pain score, mean [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 82.3  (11.9)   82.2  (9.9)   82.3  (11.3) 
[1] The Visual Analog Scale (VAS) is a 100 mm line on which the subjects mark their pain rating. 0= no pain and 100= worst pain imaginable.
ODI score, mean [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 57.2  (12.8)   56.0  (14.0)   56.8  (13.2) 
[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. If all sections are answered, the total possible score is 50/50 = 100% which is the worst disability possible on the scale. (0/50 = no disability at all.) If any section is skipped by the study participant, the total possible score for that section is removed from the denominator. Example - section 8 skipped, total possible score is 45/45 = 100%.
SF-36, mean [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Physical component summary (PCS)   30.2  (6.2)   30.8  (6.2)   30.4  (6.2) 
Mental component summary (MCS)   43.0  (11.5)   43.3  (12.1)   43.1  (11.6) 
[1]

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. 0% would represent the lowest or worst possible level of functioning while 100% would represent the highest / best possible level of functioning.

The MCS is the Mental Component Summary score. 0% would represent the lowest or worst possible level of functioning while 100% would represent the highest / best possible level of functioning.

EQ-5D [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Time trade-off (TTO) score   0.44  (0.18)   0.47  (0.19)   0.45  (0.18) 
Health Thermometer   53.2  (23.8)   57.8  (22.9)   54.6  (23.5) 
[1] EQ-5D is a five-question broad quality of life measure that is combined into a single index using population norm data called 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. (Scores <0 are also possible, representing states worse than death.) EQ-5D also includes a 0-100 mm health thermometer, where 0 means death and 100 means perfect health.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subject Success   [ Time Frame: 6 months ]

2.  Secondary:   Improvement in SI Joint Pain VAS Score at 1 Month   [ Time Frame: 1 month ]

3.  Secondary:   Improvement in Si Joint Pain VAS Score at 3 Months   [ Time Frame: 3 Months ]

4.  Secondary:   Improvement in SI Joint Pain VAS Score at 6 Months   [ Time Frame: 6 Months ]

5.  Secondary:   Improvement in SI Joint Pain VAS Score at 12 Months   [ Time Frame: 12 Months ]

6.  Secondary:   Improvement in SI Joint Pain VAS Score at 24 Months   [ Time Frame: 24 Months ]

7.  Secondary:   Improvement in Back Dysfunction   [ Time Frame: 1 month ]

8.  Secondary:   Improvement in Back Dysfunction   [ Time Frame: 3 Months ]

9.  Secondary:   Improvement in Back Dysfunction   [ Time Frame: 6 Months ]

10.  Secondary:   Improvement in Back Dysfunction   [ Time Frame: 12 Months ]

11.  Secondary:   Improvement in Back Dysfunction   [ Time Frame: 24 Months ]

12.  Secondary:   Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits   [ Time Frame: 6 months ]

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

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

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

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

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

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

19.  Secondary:   Work Status   [ Time Frame: 1 month ]

20.  Secondary:   Work Status   [ Time Frame: 3 Months ]

21.  Secondary:   Work Status   [ Time Frame: 6 Months ]

22.  Secondary:   Work Status   [ Time Frame: 12 Months ]

23.  Secondary:   Work Status   [ Time Frame: 18 Months ]

24.  Secondary:   Work Status   [ Time Frame: 24 Months ]

25.  Secondary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Daniel Cher, Vice President of Clinical Affairs
Organization: SI-BONE, Inc.
phone: 408-207-0700
e-mail: dcher@si-bone.com


Publications of Results:


Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT01681004     History of Changes
Other Study ID Numbers: 300103
First Submitted: September 1, 2012
First Posted: September 7, 2012
Results First Submitted: June 22, 2017
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017