Article Figures & Data
Figures
- Fig. 1
Pain location in subjects reporting primarily left-sided SI joint pain. Dot size is proportional to the number of subjects reporting pain in that location. Only locations shown with small squares were asked.
- Fig. 2
Postoperative outlet view of iFuse devices in the right SI joint.
- Fig. 3
Patient flow.
- Fig. 4
Improvement in VAS SI joint pain (top) and Oswestry Disability Index (bottom). Numbers in blue and green show the number of subjects in which the outcome was assessed.
- Fig. 5
Improvement in SF-36 domains at 6 months compared to baseline. Green=surgery, blue=NSM, solid line=baseline, dotted line=6 months. SF-36 domains are BP (bodily pain), GH (general health), MH (mental health), PF (physical function), RE (role emotional), RP (role physical), SF (social function), and VT (vitality).
Tables
Characteristic Non-Surgical Management (n=46) SI Joint Fusion (n=102) P-value* Age, mean (SD, range)
≥ 65 years old, n (%)54.0 (11.0, 29.5-76.0)
8 (17.4%)50.2 (11.4, 25.6-71.7)
10 (9.8%)
0.0561Women, n (% female) 28 (60.9%) 75 (73.5%) 0.1279 Race, n (%)
White
Black
American Indian
Other
43 (93.5%)
2 (4.3%)
0 (0%)
1 (2.2%)
97 (95.1%)
3 (2.9%)
1 (1.0%)
1 (1.0%)
0.6759Ethnicity
Hispanic or Latino, n (%)
4 (8.7%)
4 (3.9%)
0.2552Body mass index, mean(SD, range) 30.6 (6.6, 19.4-48.9) 30.3 (6.5, 14.1-49.5) 0.7961 Smoking status, n (%)
Current smoker
Former smoker
Never smoker
3 (6.5%)
13 (28.3%)
30 (65.2%)
26 (25.5%)
30 (29.4%)
46 (45.1%)
0.0117Ambulatory without assistance (n,%) 41 (89.1%) 89 (87.3%) 1.0 Work status (n,%)
Working full time
Working part time
Not working, student
Not working, retired
Not working due to back pain
Not working, other reason
21 (45.7%)
4 (8.7%)
0 (0%)
9 (19.6%)
8 (17.4%)
4 (8.7%)
45 (44.1%)
9 (8.8%)
1 (1.0%)
21 (20.6%)
20 (19.6%)
6 (5.9%)
0.9850Prior lumbar fusion (n,%) 17 (37.0%) 39 (38.2%) 1.0 Underlying diagnosis
Degenerative sacroiliitis
Sacroiliac joint disruption
40 (87.0%)
6 (13.0%)
88 (86.3%)
14 (13.7%)
1.0Years of pain, mean (range) 5.0 (0.48-38.9) 7.0 (0.5-40.7) 0.1270 Pain syndrome
Pain began peripartum
Pain radiates down leg
Groin pain
Pain worse with sitting
Pain worse with rising
Pain worse with walking
Pain worse with climbing stairs
Pain worse descending stairs
4 (8.7%)
41 (89.1%)
29 (63.0%)
41 (89.1%)
41 (89.1%)
42 (91.3%)
41 (89.1%)
37 (80.4%)
8 (7.8%)
89 (87.3%)
60 (58.8%)
89 (87.3%)
88 (86.3%)
87 (85.3%)
93 (91.2%)
82 (80.4%)
0.2287
1.0
0.7177
1.0
0.7926
0.4285
0.7638
1.0Prior treatments
Physical therapy
Steroid SI joint injection
RF ablation
36 (78.3%)
42 (91.3%)
4 (8.7%)
71 (69.6%)
85 (83.3%)
20 (19.6%)
0.3247
0.3082
0.1467Taking opioids (n,%) 29 (63.0%) 69 (67.6%) 0.5798 Proportion with lumbar stenosis (n,%) 7 (15.2%) 15 (14.7%) 0.8215 Proportion with hip diagnosis (n,%) 2 (4.3%) 13 (12.7%) 0.1481 Proportion with sacral trauma (n,%) 3 (6.5%) 8 (7.8%) 1.0000 VAS SI joint pain score, mean (±SD) 82.2 (9.9) 82.3 (11.9) 0.9280 ODI score, mean (±SD) 61.1 (15.3) 62.2 (14.5) 0.6902 SF-36, mean (±SD)
PCS
MCS
30.8 (6.1)
43.3 (12.1)
30.2 (6.2)
43.0 (11.5)
0.5709
0.8624EQ-5D
TTO index
Health Thermometer
0.47 (0.19)
57.8 (22.9)
0.44 (0.18)
53.2 (23.8)
0.3526
0.2716↵* Fisher p-value for ordinal variables; t test for continuous variables.
- Table 2
Minimally invasive SI joint fusion procedure characteristics (n=102). Only the index side procedure is reported.
Characteristic Value Target joint, n (%)
Right
Left
55 (53.9%)
47 (46.1%)Procedure time, minutes
Mean (SD, range)
< 30
30-60
> 60
44.9 (22.3, 14-140)
30 (29.4%)
50 (49.0%)
22 (21.6%)Fluoroscopy time, minutes
Mean (SD, range)
0-1 min
1-2 min
2-5 min
> 5 min
2.5 (3.6, 0.13-25)
17 (16.7%)
51 (50.0%)
21 (20.6%)
7 (6.9%)Estimated blood loss, cc
Mean (SD, range)
0-50
50-100
> 100
32.7 (32.8, 0.5 – 250)
92 (90.2%)
9 (8.8%)
1 (1.0%)Number of implants used, n (%)
2
3
4
5 (4.9%)
93 (91.2%)
4 (3.9%)Implant length, mm, mean (SD)
First implant, n=102
Second implant, n=102
Third implant, n=97
Fourth implant, n=4
50.5 (6.4)
45.4 (6.1)
43.8 (6.1)
42.5 (5.0)Implant diameter, n (%)
4 mm
7 mm
2 (0.7%)
303 (99.3%)Hospital length of stay, days
Mean (SD, range)
Discharged same day
1-2
3 or more
0.78 (0.97, 0-7)
42 (41.2%)
57 (55.9%)
3 (2.9%) Subgroup SI Joint Fusion NSM Rate Difference* Underlying condition
Degenerative sacroiliitis
Sacroiliac joint disruption
70/86 (81.4%, 71.6-89.0%)
13/14 (92.9%, 66.1 - 99.8%)
10/38 (26.3%, 13.4-43.1%)
1/6 (16.7%, 0.4-64.1%
54.1 (37.2-69.0%)
68.6 (31.2-93.1%)Prior lumbar fusion
Yes
No
33/39 (84.6%, 69.5-94.1%)
50/61 (82.0%, 70.0-90.6%)
2/17 (11.8%, 1.5-36.4%)
9/27 (33.3%, 16.5-54.0%)
69.9% (48.0-86.0%)
47.5% (26.9-66.1%)Smoking
Current smoker
Never smoker
Former smoker
20/25 (80.0%, 59.3-93.2%)
38/45 (84.4%, 70.5-93.5%)
25/30 (83.3%, 65.3-94.4%)
1/3 (33.3%, 0.8-90.6%)
6/29 (20.7%, 8.0-39.7%)
4/12 (33.3%, 9.9-65.1%)
41.4% (0-79.3%)
62.0% (42.6-78.2%)
47.6% (17.7-73.4%)Bilateral procedure
Yes
No
25/33 (75.8%, 57.7-88.9%)
58/67 (86.6%, 76.0-93.7%)
2/11 (18.2%, 2.3-51.8%)
9/33 (27.3%, 13.3-45.5%)
54.2% (24.7-76.8%)
58.1% (40.1-73.8%)Overall 83/102 (81.4%, 72.4-88.4%) 11/46 (23.9%, 12.6-38.8%) 56.6% (41.5-70.0%) ↵* Point estimate (95% posterior credible interval)
- Table 4
Change in SI joint pain, Oswestry Disability Index, SF-36, and EQ-5D by group and visit.
Outcome, mean (SD) NSM SIJ Fusion P-Value* VAS SIJ pain
Baseline
Mo 1
Mo 3
Mo 6
Change from baseline
Mo 1
Mo 3
Mo 6
82.2 (9.9)
69.2 (18.2)
63.5 (26.2)
70.4 (25.9)
-13.0 (14.3)
-18.7 (23.7)
-12.1 (22.7)
82.3 (11.9)
33.3 (27.3)
25.5 (25.0)
29.8 (29.3)
-49.2 (26.4)
-56.5 (27.0)
-52.6 (29.2)
<.0001
<.0001
<.0001Oswestry Disability Index (ODI)
Baseline
Mo 1
Mo 3
Mo 6
Change in ODI
Mo 1
Mo 3
Mo 6
61.1 (15.3)
57.1 (17.5)
51.1 (21.5)
56.4 (20.8)
-3.7 (11.6)
-10.3 (16.4)
-4.9 (16.4)
62.2 (14.5)
44.8 (22.1)
32.3 (21.2)
31.9 (22.7)
-17.4 (22.2)
-29.5 (21.3)
-30.3 (21.9)
<.0001
<.0001
<.0001SF-36 PCS
Baseline
Mo 6
Change from baseline
30.8 (6.1)
32.0 (7.5)
1.2 (8.0)
30.2 (6.2)
42.8 (10.0)
12.7 (10.3)
<.0001SF-36 MCS
Baseline
Mo 6
Change from baseline
43.3 (12.1)
44.0 (12.5)
0.6 (9.7)
43.0 (11.5)
49.3 (11.5)
6.2 (11.4)
.0054EQ-5D Time Trade-Off Index
Baseline
Mo 6
Change from baseline
0.47 (0.19)
0.52 (0.22)
0.05 (0.27)
0.44 (0.18)
0.72 (0.21)
0.29 (0.22)
<.0001↵* T test for comparison of individual time points.
** Repeated measures analysis of variance (VAS, ODI, SF-36) or t test (EQ-5D).
NSM (n=46) SI Joint Fusion (n=102) Body system N (%) N (%) P-value Arm/hand 2 (4.3%) 9 (8.8%) 0.5035 Back 4 (8.7%) 16 (15.7) 0.3070 Cardiovascular 1 (2.2%) 6 (5.9%) 0.4360 Endocrine 1 (2.2%) 1 (1.0%) 0.5265 Gastroenterologic 4 (8.7%) 11 (10.8%) 0.7779 Genitourinary 0 (0%) 5 (4.9%) 0.3248 Infection 3 (6.5%) 3 (2.9%) 0.3752 Leg 8 (17.4%) 21 (20.6%) 0.8234 Miscellaneous 4 (8.7%) 3 (2.9%) 0.2042 Neck 0 (0.0%) 2 (2.0%) 1.0000 Pelvis 10 (21.7%) 34 (33.3%) 0.1773 Psychiatric 0 (0.0%) 1 (1.0%) 1.0000 Pulmonary 4 (8.7%) 1 (1.0%) 0.0326 Surgical wound 0 (0.0%) 6 (5.9%) 0.1774 Trauma 7 (15.2%) 14 (13.7%) 0.8033 * Number of events and rate (events divided by total number of trial subjects)
- Table 6
Adverse events related to device, procedure, other treatment for SI joint pain or pre-existing condition.
NSM (n=46) SI Joint Fusion (n=102) Category N (%*) N (%) Related to iFuse implant
Definitely related
Probably related
Total
-
-
-
2 (2.0%)
1 (1.0%)
3 (2.9%)Related to NSM or iFuse procedure**
Definitely related
Probably related
Total
3 (6.5%)
1 (2.2%)
4 (8.7%)
7 (6.9%)
10 (9.8%)
17 (16.7%)Related to other treatment for SIJ pain
Definitely related
Probably related
Total
0 (0%)
0 (0%)
0 (0%)
0 (0%)
1 (1.0%)
1 (1.0%)Related to pre-existing condition
Definitely related
Probably related
Total
11 (23.9%)
6 (13.0%)
17 (37.0%)
23 (22.5%)
17 (16.7%)
40 (39.2%)↵* Percent reported as number of events divided by number assigned to treatment.
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