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Investigation of Sacroiliac Fusion Treatment (INSITE) (INSITE)

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.
ClinicalTrials.gov Identifier: NCT01681004
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.

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
Enrollment 159
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

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.

Period Title: Primary Endpoint: 6 Months
Started 102 46
Crossover to Surgical Treatment 0 39 [1]
Completed 101 44
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             2
[1]
Crossover to surgical treatment allowed per study protocol after the 6-month visit was complete.
Period Title: Study Completion
Started 101 44
Completed 89 36
Not Completed 12 8
Reason Not Completed
Lost to Follow-up             8             3
Physician Decision             1             3
Site Termination             2             1
Death             1             1
Arm/Group Title iFuse Implant System Non-Surgical Management Total
Hide Arm/Group Description

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

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 of all reporting groups
Overall Number of Baseline Participants 102 46 148
Hide Baseline Analysis Population Description
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
Female
75
  73.5%
28
  60.9%
103
  69.6%
Male
27
  26.5%
18
  39.1%
45
  30.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
White
97
  95.1%
44
  95.7%
141
  95.3%
Black
3
   2.9%
2
   4.3%
5
   3.4%
American Indian
1
   1.0%
0
   0.0%
1
   0.7%
Other
1
   1.0%
0
   0.0%
1
   0.7%
Ethnicity: Hispanic or Latino
4
   3.9%
4
   8.7%
8
   5.4%
Body Mass Index, mean (range)  
Mean (Full Range)
Unit of measure:  Kg / m2
Number Analyzed 102 participants 46 participants 148 participants
30.4
(16.7 to 49.5)
30.6
(19.4 to 48.9)
30.43
(16.7 to 49.5)
Smoking Status (n, %)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
Current Smoker 26 3 29
Former Smoker 30 13 43
Never smoker 46 30 76
Ambulatory without assistance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
89
  87.3%
41
  89.1%
130
  87.8%
Work status (n, %)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
Working full time
45
  44.1%
21
  45.7%
66
  44.6%
Working part time
9
   8.8%
4
   8.7%
13
   8.8%
Not working, student
1
   1.0%
0
   0.0%
1
   0.7%
Not working, retired
21
  20.6%
9
  19.6%
30
  20.3%
Not working due to back pain
20
  19.6%
8
  17.4%
28
  18.9%
Not working other reason
6
   5.9%
4
   8.7%
10
   6.8%
Prior Lumbar fusion (n, %)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
41
  40.2%
17
  37.0%
58
  39.2%
Underlying diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
Degenerative sacroiliitis
88
  86.3%
40
  87.0%
128
  86.5%
Sacroiliac joint disruption
14
  13.7%
6
  13.0%
20
  13.5%
Years of pain, mean (range)  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 102 participants 46 participants 148 participants
7.0
(0.5 to 40.7)
5.0
(0.5 to 38.9)
6.0
(0.5 to 40.7)
Pain Syndrome  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
Pain began peripartum
29
  28.4%
19
  41.3%
48
  32.4%
Pain radiates down leg
89
  87.3%
41
  89.1%
130
  87.8%
Groin pain
60
  58.8%
29
  63.0%
89
  60.1%
Pain worse with sitting
89
  87.3%
41
  89.1%
130
  87.8%
Pain worse with rising
88
  86.3%
41
  89.1%
129
  87.2%
Pain worse with walking
87
  85.3%
42
  91.3%
129
  87.2%
Pain worse with climbing stairs
93
  91.2%
41
  89.1%
134
  90.5%
Pain worse with descending stairs
82
  80.4%
37
  80.4%
119
  80.4%
Prior treatments  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
Physical therapy
71
  69.6%
36
  78.3%
107
  72.3%
Steroid SIJ injection
85
  83.3%
42
  91.3%
127
  85.8%
RF ablation
21
  20.6%
4
   8.7%
25
  16.9%
Taking opiods  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
70
  68.6%
29
  63.0%
99
  66.9%
Participants with lumbar stenosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
15
  14.7%
7
  15.2%
22
  14.9%
Participants with hip diagnosis (n, %)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
16
  15.7%
3
   6.5%
19
  12.8%
Participants with sacral trauma (n, %)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 46 participants 148 participants
8
   7.8%
3
   6.5%
11
   7.4%
VAS SIJ pain score, mean   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 46 participants 148 participants
82.3  (11.9) 82.2  (9.9) 82.3  (11.3)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 46 participants 148 participants
57.2  (12.8) 56.0  (14.0) 56.8  (13.2)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 46 participants 148 participants
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]
Measure Description:

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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 46 participants 148 participants
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]
Measure Description: 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.
1.Primary Outcome
Title Subject Success
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
A modified intent-to-treat approach was used.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM with reporting to 6 months only.

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

Overall Number of Participants Analyzed 102 46
Measure Type: Count of Participants
Unit of Measure: Participants
84
  82.4%
12
  26.1%
2.Secondary Outcome
Title Improvement in SI Joint Pain VAS Score at 1 Month
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 iFuse and 1 NSM subjects did not complete the pain score.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM.

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

Overall Number of Participants Analyzed 100 45
Measure Type: Count of Participants
Unit of Measure: Participants
84
  84.0%
13
  28.9%
3.Secondary Outcome
Title Improvement in Si Joint Pain VAS Score at 3 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 iFuse and 3 NSM subjects did not complete the 3-month pain score.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM.

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

Overall Number of Participants Analyzed 100 43
Measure Type: Count of Participants
Unit of Measure: Participants
87
  87.0%
17
  39.5%
4.Secondary Outcome
Title Improvement in SI Joint Pain VAS Score at 6 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
1 iFuse and 3 NSM subjects did not complete the 6-month pain score.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM.

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

Overall Number of Participants Analyzed 101 43
Measure Type: Count of Participants
Unit of Measure: Participants
84
  83.2%
12
  27.9%
5.Secondary Outcome
Title Improvement in SI Joint Pain VAS Score at 12 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 iFuse subjects did not complete the 12-month pain score. Analysis of 12-month scores in the NSM group is not valid because of the high crossover rate.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 100 6
Measure Type: Count of Participants
Unit of Measure: Participants
81
  81.0%
NA [1] 
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
6.Secondary Outcome
Title Improvement in SI Joint Pain VAS Score at 24 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
12 iFuse subjects did not complete the 24-month pain score. Analysis of 24-month scores in the NSM group is not valid because of the high crossover rate.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 90 5
Measure Type: Count of Participants
Unit of Measure: Participants
75
  83.3%
NA [1] 
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
7.Secondary Outcome
Title Improvement in Back Dysfunction
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
2 iFuse and 1 NSM subjects did not complete ODI at 1 month
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 100 45
Measure Type: Count of Participants
Unit of Measure: Participants
49
  49.0%
6
  13.3%
8.Secondary Outcome
Title Improvement in Back Dysfunction
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
2 iFuse subjects and 3 NSM subjects did not complete ODI at month 3.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM.

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

Overall Number of Participants Analyzed 100 43
Measure Type: Count of Participants
Unit of Measure: Participants
72
  72.0%
13
  30.2%
9.Secondary Outcome
Title Improvement in Back Dysfunction
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
1 iFuse and 2 NSM subjects did not complete ODI at month 6.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM.

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

Overall Number of Participants Analyzed 101 44
Measure Type: Count of Participants
Unit of Measure: Participants
74
  73.3%
6
  13.6%
10.Secondary Outcome
Title Improvement in Back Dysfunction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
2 iFuse subjects did not complete ODI at month 12. ODI analysis is not valid in NSM group at 12 months because of high crossover.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 100 6
Measure Type: Count of Participants
Unit of Measure: Participants
72
  72.0%
NA [1] 
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
11.Secondary Outcome
Title Improvement in Back Dysfunction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Count of participants = number of subjects that had a threshold change in ODI score of greater than or equal to 15 points. Overall number of participants = number of subjects analyzed. Of the 102, a total of 13 iFuse Implant subjects exited the study and 1 did not complete the ODI survey. By 6 months, 39 NSM subjects crossed over to surgical.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 88 40
Measure Type: Count of Participants
Unit of Measure: Participants
60
  68.2%
NA [1] 
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
12.Secondary Outcome
Title Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
2 iFuse and 2 NSM subjects did not complete SF-36 at month 6.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 100 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.5  (10.5) 1.3  (8.2)
13.Secondary Outcome
Title Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 2 iFuse subjects had exited the study before making it to their 12 month visit. This outcome is not evaluated in the NSM group at month 12 because high crossover to surgical treatment prevents valid analysis.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 100 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.0  (9.9) NA [1]   (NA)
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
14.Secondary Outcome
Title Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Change in QOL score at 24 months. 89 participants had QOL information at 24 months. Analysis of the NSM cohort is not done because high crossover to surgery prevents valid analysis.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 89 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.2  (10.7) NA [1]   (NA)
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
15.Secondary Outcome
Title Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Results show improvement in score from baseline.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 100 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.29  (0.22) 0.06  (0.28)
16.Secondary Outcome
Title Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
2 iFuse subjects did not complete the survey at month 12. Due to high crossover rate to surgery, analysis in the NSM group is not valid.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 100 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.31  (0.22) NA [1]   (NA)
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
17.Secondary Outcome
Title Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
13 iFuse subjects did not complete the 24-month assessment. Analysis was not done for the NSM group at 24 months due to the high crossover rate.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 89 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.29  (0.24) NA [1]   (NA)
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
18.Secondary Outcome
Title Ambulatory Status
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of days to full ambulation among those without full ambulation at baseline. At baseline only 13 in the surgical arm were not Ambulatory without assistance and for the NSM group, it was only 5 at baseline.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months..

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

Overall Number of Participants Analyzed 13 5
Median (95% Confidence Interval)
Unit of Measure: Days, median
60 [1] 
(46 to NA)
NA [2] 
(NA to NA)
[1]
Upper confidence limit not defined due to small sample size.
[2]
By month 6, only 40% of non-ambulatory NSM subjects regained full ambulation status
19.Secondary Outcome
Title Work Status
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients not working at baseline due to back or other pain. Note this is a subset of the entire population.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 26 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
   7.7%
0
   0.0%
20.Secondary Outcome
Title Work Status
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients not working at baseline due to back or other pain
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 26 12
Measure Type: Count of Participants
Unit of Measure: Participants
3
  11.5%
0
   0.0%
21.Secondary Outcome
Title Work Status
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients not working at baseline due to back or other pain
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 26 12
Measure Type: Count of Participants
Unit of Measure: Participants
5
  19.2%
0
   0.0%
22.Secondary Outcome
Title Work Status
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients not working at baseline due to back or other pain
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 26 6
Measure Type: Count of Participants
Unit of Measure: Participants
4
  15.4%
NA [1] 
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
23.Secondary Outcome
Title Work Status
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients not working at baseline due to back or other pain
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 23 5
Measure Type: Count of Participants
Unit of Measure: Participants
3
  13.0%
NA [1] 
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
24.Secondary Outcome
Title Work Status
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients not working at baseline due to back or other pain
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months.

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

Overall Number of Participants Analyzed 23 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
   8.7%
NA [1] 
[1]
The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.
25.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All treated study subjects.
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description:

Surgical placement of iFuse implants in the affected SI joint

iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM. Many of these subjects crossed over to treatment after 6 months of NSM.
Overall Number of Participants Analyzed 102 46
Measure Type: Count of Participants
Unit of Measure: Participants
38
  37.3%
12
  26.1%
Time Frame 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title iFuse Implant System Non-Surgical Management
Hide Arm/Group Description Surgical placement of iFuse implants in the affected SI joint iFuse Implant System: Placement of iFuse implant system via surgery

This arm includes all subjects randomized to NSM followed to 6 months

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

All-Cause Mortality
iFuse Implant System Non-Surgical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   1/102 (0.98%)      1/46 (2.17%)    
Show Serious Adverse Events Hide Serious Adverse Events
iFuse Implant System Non-Surgical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/102 (37.25%)      12/46 (26.09%)    
Cardiac disorders     
Syncope   2/102 (1.96%)  2 0/46 (0.00%)  0
Coronary artery disease   1/102 (0.98%)  1 0/46 (0.00%)  0
Myocardial infarction - fatal  [1]  1/102 (0.98%)  1 0/46 (0.00%)  0
Eye disorders     
Glaucoma   0/102 (0.00%)  0 1/46 (2.17%)  1
Gastrointestinal disorders     
Gastroenteritis   1/102 (0.98%)  1 0/46 (0.00%)  0
Small bowel obstruction   0/102 (0.00%)  0 1/46 (2.17%)  1
Gastroparesis   1/102 (0.98%)  1 0/46 (0.00%)  0
Bowel obstruct, leading to surgery  [2]  1/102 (0.98%)  1 0/46 (0.00%)  0
Esophagitis   1/102 (0.98%)  1 0/46 (0.00%)  0
Gastric ulcer   1/102 (0.98%)  1 0/46 (0.00%)  0
General disorders     
Benign prostatic hypertrophy   1/102 (0.98%)  1 0/46 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis   1/102 (0.98%)  1 0/46 (0.00%)  0
Biliary colic   1/102 (0.98%)  1 0/46 (0.00%)  0
Injury, poisoning and procedural complications     
Wound hematoma   1/102 (0.98%)  1 0/46 (0.00%)  0
Revision - SIJ pain   2/102 (1.96%)  2 0/46 (0.00%)  0
Revision - neuropathy   1/102 (0.98%)  1 0/46 (0.00%)  0
Neuropathy - Resolved with revision   0/102 (0.00%)  0 1/46 (2.17%)  1
Atrial fibrillation / respira failure   1/102 (0.98%)  1 0/46 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes mellitus   1/102 (0.98%)  1 0/46 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoarthritis of the knee   1/102 (0.98%)  1 0/46 (0.00%)  0
Meniscal tear   4/102 (3.92%)  4 1/46 (2.17%)  2
Contralateral SIJ pain   10/102 (9.80%)  10 0/46 (0.00%)  0
Degenerative disease - spine   7/102 (6.86%)  7 1/46 (2.17%)  1
Ankle fracture   0/102 (0.00%)  0 1/46 (2.17%)  1
Disc herniation   1/102 (0.98%)  2 0/46 (0.00%)  0
Rotator cuff tear   1/102 (0.98%)  1 0/46 (0.00%)  0
Back pain   3/102 (2.94%)  3 1/46 (2.17%)  1
Ipsilateral - SIJ pain   0/102 (0.00%)  0 1/46 (2.17%)  1
Osteoarthritis of the hip   2/102 (1.96%)  2 0/46 (0.00%)  0
Avascular necrosis of left hip   0/102 (0.00%)  0 1/46 (2.17%)  1
Hip revision   1/102 (0.98%)  1 0/46 (0.00%)  0
Restrolisthesis T12-L1   1/102 (0.98%)  1 0/46 (0.00%)  0
Fracture - tibia / fibula   0/102 (0.00%)  0 1/46 (2.17%)  1
Knee pain   0/102 (0.00%)  0 1/46 (2.17%)  1
Labral tear & ilium fracture   1/102 (0.98%)  1 0/46 (0.00%)  0
Snapping scapula syndrome   0/102 (0.00%)  0 1/46 (2.17%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Dysfunctional uterine bleeding   1/102 (0.98%)  1 0/46 (0.00%)  0
Nervous system disorders     
S1 neuropathy   1/102 (0.98%)  1 0/46 (0.00%)  0
Seizure   0/102 (0.00%)  0 1/46 (2.17%)  1
Psychiatric disorders     
Depression   1/102 (0.98%)  1 0/46 (0.00%)  0
Renal and urinary disorders     
Kidney disfunction due to nsaid   0/102 (0.00%)  0 1/46 (2.17%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism   1/102 (0.98%)  1 0/46 (0.00%)  0
COPD   0/102 (0.00%)  0 1/46 (2.17%)  1
Pleurisy   1/102 (0.98%)  1 0/46 (0.00%)  0
Pneumonia   0/102 (0.00%)  0 1/46 (2.17%)  1
Indicates events were collected by systematic assessment
[1]
Myocardial infarction - fatal
[2]
Bowel obstruct, leading to surgery
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
iFuse Implant System Non-Surgical Management
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   69/102 (67.65%)      35/46 (76.09%)    
Infections and infestations     
Upper respiratory infection   5/102 (4.90%)  5 4/46 (8.70%)  5
Musculoskeletal and connective tissue disorders     
Knee pain   6/102 (5.88%)  7 3/46 (6.52%)  3
Back pain   27/102 (26.47%)  29 8/46 (17.39%)  8
Degenerative disease - spine   17/102 (16.67%)  19 12/46 (26.09%)  16
SIJ pain - ipsilateral   13/102 (12.75%)  14 10/46 (21.74%)  11
Shoulder pain   8/102 (7.84%)  8 2/46 (4.35%)  2
SIJ pain - contralateral   12/102 (11.76%)  12 6/46 (13.04%)  6
Trochanteric bursitis   12/102 (11.76%)  14 4/46 (8.70%)  4
Leg pain   0/102 (0.00%)  0 4/46 (8.70%)  5
Hip pain   7/102 (6.86%)  7 0/46 (0.00%)  0
Indicates events were collected by systematic assessment
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.
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
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