Trial Outcomes & Findings for Investigation of Sacroiliac Fusion Treatment (INSITE) (NCT NCT01681004)
NCT ID: NCT01681004
Last Updated: 2017-08-25
Results Overview
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.
COMPLETED
NA
159 participants
6 months
2017-08-25
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Primary Endpoint: 6 Months
STARTED
|
102
|
46
|
|
Primary Endpoint: 6 Months
Crossover to Surgical Treatment
|
0
|
39
|
|
Primary Endpoint: 6 Months
COMPLETED
|
101
|
44
|
|
Primary Endpoint: 6 Months
NOT COMPLETED
|
1
|
2
|
|
Study Completion
STARTED
|
101
|
44
|
|
Study Completion
COMPLETED
|
89
|
36
|
|
Study Completion
NOT COMPLETED
|
12
|
8
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Primary Endpoint: 6 Months
Withdrawal by Subject
|
1
|
2
|
|
Study Completion
Lost to Follow-up
|
8
|
3
|
|
Study Completion
Physician Decision
|
1
|
3
|
|
Study Completion
Site Termination
|
2
|
1
|
|
Study Completion
Death
|
1
|
1
|
Baseline Characteristics
Investigation of Sacroiliac Fusion Treatment (INSITE)
Baseline characteristics by cohort
| Measure |
iFuse Implant System
n=102 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=46 Participants
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
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
VAS SIJ pain score, mean
|
82.3 units on a scale
STANDARD_DEVIATION 11.9 • n=5 Participants
|
82.2 units on a scale
STANDARD_DEVIATION 9.9 • n=7 Participants
|
82.3 units on a scale
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
92 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
97 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Body Mass Index, mean (range)
|
30.4 kg / m2
n=5 Participants
|
30.6 kg / m2
n=7 Participants
|
30.43 kg / m2
n=5 Participants
|
|
Smoking Status (n, %)
Current Smoker
|
26 participants
n=5 Participants
|
3 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Smoking Status (n, %)
Former Smoker
|
30 participants
n=5 Participants
|
13 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Smoking Status (n, %)
Never smoker
|
46 participants
n=5 Participants
|
30 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Ambulatory without assistance
|
89 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Work status (n, %)
Working full time
|
45 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Work status (n, %)
Working part time
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Work status (n, %)
Not working, student
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Work status (n, %)
Not working, retired
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Work status (n, %)
Not working due to back pain
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Work status (n, %)
Not working other reason
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Prior Lumbar fusion (n, %)
|
41 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Underlying diagnosis
Degenerative sacroiliitis
|
88 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Underlying diagnosis
Sacroiliac joint disruption
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Years of pain, mean (range)
|
7.0 years
n=5 Participants
|
5.0 years
n=7 Participants
|
6.0 years
n=5 Participants
|
|
Pain Syndrome
Pain began peripartum
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Pain Syndrome
Pain radiates down leg
|
89 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Pain Syndrome
Groin pain
|
60 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Pain Syndrome
Pain worse with sitting
|
89 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Pain Syndrome
Pain worse with rising
|
88 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Pain Syndrome
Pain worse with walking
|
87 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Pain Syndrome
Pain worse with climbing stairs
|
93 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Pain Syndrome
Pain worse with descending stairs
|
82 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Prior treatments
Physical therapy
|
71 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Prior treatments
Steroid SIJ injection
|
85 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Prior treatments
RF ablation
|
21 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Taking opiods
|
70 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Participants with lumbar stenosis
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Participants with hip diagnosis (n, %)
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Participants with sacral trauma (n, %)
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
ODI score, mean
|
57.2 units on a scale
STANDARD_DEVIATION 12.8 • n=5 Participants
|
56.0 units on a scale
STANDARD_DEVIATION 14.0 • n=7 Participants
|
56.8 units on a scale
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
SF-36, mean
Physical component summary (PCS)
|
30.2 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
30.8 units on a scale
STANDARD_DEVIATION 6.2 • n=7 Participants
|
30.4 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
SF-36, mean
Mental component summary (MCS)
|
43.0 units on a scale
STANDARD_DEVIATION 11.5 • n=5 Participants
|
43.3 units on a scale
STANDARD_DEVIATION 12.1 • n=7 Participants
|
43.1 units on a scale
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
EQ-5D
Time trade-off (TTO) score
|
0.44 units on a scale
STANDARD_DEVIATION 0.18 • n=5 Participants
|
0.47 units on a scale
STANDARD_DEVIATION 0.19 • n=7 Participants
|
0.45 units on a scale
STANDARD_DEVIATION 0.18 • n=5 Participants
|
|
EQ-5D
Health Thermometer
|
53.2 units on a scale
STANDARD_DEVIATION 23.8 • n=5 Participants
|
57.8 units on a scale
STANDARD_DEVIATION 22.9 • n=7 Participants
|
54.6 units on a scale
STANDARD_DEVIATION 23.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: A modified intent-to-treat approach was used.
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.
Outcome measures
| Measure |
iFuse Implant System
n=102 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=46 Participants
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.
|
|---|---|---|
|
Subject Success
|
84 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: 2 iFuse and 1 NSM subjects did not complete the pain score.
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.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=45 Participants
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.
|
|---|---|---|
|
Improvement in SI Joint Pain VAS Score at 1 Month
|
84 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 2 iFuse and 3 NSM subjects did not complete the 3-month pain score.
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.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=43 Participants
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.
|
|---|---|---|
|
Improvement in Si Joint Pain VAS Score at 3 Months
|
87 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: 1 iFuse and 3 NSM subjects did not complete the 6-month pain score.
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.
Outcome measures
| Measure |
iFuse Implant System
n=101 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=43 Participants
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.
|
|---|---|---|
|
Improvement in SI Joint Pain VAS Score at 6 Months
|
84 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=6 Participants
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.
|
|---|---|---|
|
Improvement in SI Joint Pain VAS Score at 12 Months
|
81 Participants
|
NA Participants
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.
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
iFuse Implant System
n=90 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=5 Participants
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.
|
|---|---|---|
|
Improvement in SI Joint Pain VAS Score at 24 Months
|
75 Participants
|
NA Participants
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.
|
SECONDARY outcome
Timeframe: 1 monthPopulation: 2 iFuse and 1 NSM subjects did not complete ODI at 1 month
Improvement in ODI score of greater than or equal to 15 points, at month 1. Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled). Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=45 Participants
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.
|
|---|---|---|
|
Improvement in Back Dysfunction
|
49 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 2 iFuse subjects and 3 NSM subjects did not complete ODI at month 3.
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.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=43 Participants
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.
|
|---|---|---|
|
Improvement in Back Dysfunction
|
72 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: 1 iFuse and 2 NSM subjects did not complete ODI at month 6.
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.
Outcome measures
| Measure |
iFuse Implant System
n=101 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=44 Participants
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.
|
|---|---|---|
|
Improvement in Back Dysfunction
|
74 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=6 Participants
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.
|
|---|---|---|
|
Improvement in Back Dysfunction
|
72 Participants
|
NA Participants
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.
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
iFuse Implant System
n=88 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=40 Participants
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.
|
|---|---|---|
|
Improvement in Back Dysfunction
|
60 Participants
|
NA Participants
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.
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 2 iFuse and 2 NSM subjects did not complete SF-36 at month 6.
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.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=44 Participants
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.
|
|---|---|---|
|
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
|
12.5 units on a scale
Standard Deviation 10.5
|
1.3 units on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=6 Participants
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.
|
|---|---|---|
|
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
|
13.0 units on a scale
Standard Deviation 9.9
|
NA units on a scale
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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.
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.
Outcome measures
| Measure |
iFuse Implant System
n=89 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=5 Participants
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.
|
|---|---|---|
|
Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
|
11.2 units on a scale
Standard Deviation 10.7
|
NA units on a scale
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Results show improvement in score from baseline.
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.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=44 Participants
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.
|
|---|---|---|
|
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
|
0.29 units on a scale
Standard Deviation 0.22
|
0.06 units on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
iFuse Implant System
n=100 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=6 Participants
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.
|
|---|---|---|
|
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
|
0.31 units on a scale
Standard Deviation 0.22
|
NA units on a scale
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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.
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.
Outcome measures
| Measure |
iFuse Implant System
n=89 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=5 Participants
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.
|
|---|---|---|
|
Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
|
0.29 units on a scale
Standard Deviation 0.24
|
NA units on a scale
Standard Deviation NA
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.
|
SECONDARY outcome
Timeframe: 24 months (surgical group), 6 months (non-surgical group)Population: 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.
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.
Outcome measures
| Measure |
iFuse Implant System
n=13 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=5 Participants
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.
|
|---|---|---|
|
Ambulatory Status
|
60 Days, median
Interval 46.0 to
Upper confidence limit not defined due to small sample size.
|
NA Days, median
By month 6, only 40% of non-ambulatory NSM subjects regained full ambulation status
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Patients not working at baseline due to back or other pain. Note this is a subset of the entire population.
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.
Outcome measures
| Measure |
iFuse Implant System
n=26 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=12 Participants
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.
|
|---|---|---|
|
Work Status
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: Patients not working at baseline due to back or other pain
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.
Outcome measures
| Measure |
iFuse Implant System
n=26 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=12 Participants
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.
|
|---|---|---|
|
Work Status
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Patients not working at baseline due to back or other pain
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.
Outcome measures
| Measure |
iFuse Implant System
n=26 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=12 Participants
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.
|
|---|---|---|
|
Work Status
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Patients not working at baseline due to back or other pain
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.
Outcome measures
| Measure |
iFuse Implant System
n=26 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=6 Participants
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.
|
|---|---|---|
|
Work Status
|
4 Participants
|
NA Participants
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.
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: Patients not working at baseline due to back or other pain
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.
Outcome measures
| Measure |
iFuse Implant System
n=23 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=5 Participants
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.
|
|---|---|---|
|
Work Status
|
3 Participants
|
NA Participants
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.
|
SECONDARY outcome
Timeframe: 24 MonthsPopulation: Patients not working at baseline due to back or other pain
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.
Outcome measures
| Measure |
iFuse Implant System
n=23 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=5 Participants
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.
|
|---|---|---|
|
Work Status
|
2 Participants
|
NA Participants
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.
|
SECONDARY outcome
Timeframe: Procedure, discharge, 1, 3, 6, 12, 18 and 24 monthsPopulation: All treated study subjects.
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.
Outcome measures
| Measure |
iFuse Implant System
n=102 Participants
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=46 Participants
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.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
38 Participants
|
12 Participants
|
Adverse Events
iFuse Implant System
Non-Surgical Management
Serious adverse events
| Measure |
iFuse Implant System
n=102 participants at risk
Surgical placement of iFuse implants in the affected SI joint iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=46 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis of the knee
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Meniscal tear
|
3.9%
4/102 • Number of events 4 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Contralateral SIJ pain
|
9.8%
10/102 • Number of events 10 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative disease - spine
|
6.9%
7/102 • Number of events 7 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Disc herniation
|
0.98%
1/102 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
3/102 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Ipsilateral - SIJ pain
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis of the hip
|
2.0%
2/102 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis of left hip
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Hip revision
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Restrolisthesis T12-L1
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Fracture - tibia / fibula
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Labral tear & ilium fracture
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Snapping scapula syndrome
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Wound hematoma
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Revision - SIJ pain
|
2.0%
2/102 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Revision - neuropathy
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Neuropathy - Resolved with revision
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Atrial fibrillation / respira failure
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Syncope
|
2.0%
2/102 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Coronary artery disease
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Myocardial infarction - fatal
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Gastroparesis
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Bowel obstruct, leading to surgery
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Esophagitis
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
S1 neuropathy
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Eye disorders
Glaucoma
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Hepatobiliary disorders
Biliary colic
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
General disorders
Benign prostatic hypertrophy
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysfunctional uterine bleeding
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Renal and urinary disorders
Kidney disfunction due to nsaid
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
2.2%
1/46 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Psychiatric disorders
Depression
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.98%
1/102 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
Other adverse events
| Measure |
iFuse Implant System
n=102 participants at risk
Surgical placement of iFuse implants in the affected SI joint iFuse Implant System: Placement of iFuse implant system via surgery
|
Non-Surgical Management
n=46 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
5.9%
6/102 • Number of events 7 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
6.5%
3/46 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.5%
27/102 • Number of events 29 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
17.4%
8/46 • Number of events 8 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative disease - spine
|
16.7%
17/102 • Number of events 19 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
26.1%
12/46 • Number of events 16 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
SIJ pain - ipsilateral
|
12.7%
13/102 • Number of events 14 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
21.7%
10/46 • Number of events 11 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
7.8%
8/102 • Number of events 8 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
4.3%
2/46 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
SIJ pain - contralateral
|
11.8%
12/102 • Number of events 12 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
13.0%
6/46 • Number of events 6 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Trochanteric bursitis
|
11.8%
12/102 • Number of events 14 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
8.7%
4/46 • Number of events 4 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/102 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
8.7%
4/46 • Number of events 5 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
6.9%
7/102 • Number of events 7 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
0.00%
0/46 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Infections and infestations
Upper respiratory infection
|
4.9%
5/102 • Number of events 5 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
8.7%
4/46 • Number of events 5 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
Additional Information
Daniel Cher, Vice President of Clinical Affairs
SI-BONE, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place