Research ArticleArticles

Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction

David W. Polly, John Swofford, Peter G. Whang, Clay J. Frank, John A. Glaser, Robert P. Limoni, Daniel J. Cher, Kathryn D. Wine, Jonathan N. Sembrano and and the INSITE Study Group
International Journal of Spine Surgery January 2016, 10 28; DOI: https://doi.org/10.14444/3028

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Tables

  • Table 1

    Characteristics of enrolled subjects.

    CharacteristicNon-Surgical Management (n = 46)SIJ Fusion (n = 102)P-value*
    Age, mean (SD, range)
      ≥ 65 years old, n (%)    		53.8 (29.5-71.1)
    8 (17.4%)    		50.2 (25.6-71.7)
    10 (9.8%)    		0.0627
    Women, n (% female)28 60.9%75 (73.5%)0.1279
    Race, n (%)
     White
     Black
     American Indian
     Other
    44 (95.7%)
    2 (4.3%)
    0 (0.0%)
    0 (0.0%)
    97 (95.1%)
    3 (2.9%)
    1 (1.0%)
    1 (1.0%)    		0.8344
    Ethnicity
     Hispanic or Latino, n (%)
    4 (8.7%)
    4 (3.9%)    		0.2552
    Body mass index, mean (range)30.6 (19.4-48.9)30.4 (16.7-49.5)0.8331
    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%)    		0.0117
    Ambulatory without assistance (n,%)41 (89.1%)89 (87.3%)1.0000
    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 (0.0%)
    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%)    		0.9850
    Prior lumbar fusion (n,%)17 (37.0%)41 (40.2%)0.8558
    Underlying diagnosis
     Degenerative sacroiliitis
     Sacroiliac joint disruption
    40 (87.0%)
    6 (13.0%)
    88 (86.3%)
    14 (13.7%)    		1.0000
    Years of pain, mean (range)5.0 (0.5-38.9)7.0 (0.5-40.7)0.1037
    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    		19 (41.3%)
    41 (89.1%)
    29 (63.0%)
    41 (89.1%)
    41 (89.1%)
    42 (91.3%)
    41 (89.1%)
    37 (80.4%)
    29 (28.4%)
    89 (87.3%)
    60 (58.8%)
    89 (87.3%)
    88 (86.3%)
    87 (85.3%)
    93 (91.2%)
    82 (80.4%)
    0.2710
    1.0000
    0.7177
    1.0000
    0.7926
    0.4285
    0.7638
    1.0000
    Prior treatments
     Physical therapy
     Steroid SIJ injection
     RF ablation
    36 (78.3%)
    42 (91.3%)
    4 (8.7%)
    71 (69.6%)
    85 (83.3%)
    21 (20.6%)
    0.3247
    0.3082
    0.0972
    Taking opioids (n,%)29 (63.0%)70 (68.6%)0.6317
    Proportion with lumbar stenosis (n,%)7 (15.2%)15 (14.7%)1.0000
    Proportion with hip diagnosis (n,%)3 (6.5%)16 (15.7%)0.1837
    Proportion with sacral trauma (n,%)3 (6.5%)8 (7.8%)1.0000
    VAS SIJ pain score, mean (±SD)82.2 (9.9)82.3 (11.9)0.9280
    ODI score, mean (±SD)56.0 (14.0)57.2 (12.8)0.6328
    SF-36, mean (±SD)
     PCS
     MCS
    30.8 (6.1)
    43.3 (12.1)
    30.2 (6.2)
    43.0 (11.5)
    0.5709
    0.8624
    EQ-5D
     TTO index
     Health Thermometer
    0.47 (0.19)
    57.8 (22.9)
    0.44 (0.18)
    53.2 (23.8)
    0.3376
    0.2776

    • ↵* Fisher p-value for nominal variables; t test for continuous variables.

  • Table 2

    Minimally invasive SIJF procedure characteristics (n = 102). Only the index side procedure is reported.

    CharacteristicValue
    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
     1-2
     2-5
      > 5 w
    2.5 (3.6) (0.13-25.4)
    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%)
    Hospital length of stay, days
     Mean (SD, range)
     Discharged same day
     1-2 days
     3 or more days
    0.8 (1.0) (0-7)
    42 (41.2%)
    57 (55.9%)
    3 (2.9%)
  • Table 3

    Six-month success rates and subgroup analysis. Each cell shows number of successes / number treated, success rate and 95% posterior credible intervals in parentheses.

    SubgroupLevelSIJ FusionNSMRate Difference*
    DiagnosisDegenerative sacroiliitis71/88, 80.7%
    (70.9-88.3%)    		11/40, 27.5%
    (14.6-43.9%)    		52.3%
    (35.6-67.2%)
    Sacroiliac joint disruption13/14, 92.9%
    (66.1-99.8%)    		1/6, 16.7%
    (0.4-64.1%)    		68.5%
    (31.0-93.1%)
    History of lumbar fusionYes35/41, 85.4%
    (70.8-94.4%)    		3/17, 17.6%
    (3.8-43.4%)    		65.1%
    (41.8-83.0%)
    No49/61, 80.3%
    (68.2-89.4%)    		9/29, 31.0%
    (15.3-50.8%)    		48.2%
    (28.0-66.1%)
    SmokingCurrent20/26, 76.9%
    (56.4-91.0%)    		1/3, 33.3%
    (0.8-90.6%)    		38.5%
    (0-76.7%)
    Never39/46, 84.8%
    (71.1-93.7%)    		7/30, 23.3%
    (9.9-42.3%)    		59.8%
    (40.4-76.4%)
    Former25/30, 83.3%
    (65.3-94.4%)    		4/13, 30.8%
    (9.1-61.4%)    		50.1%
    (21.2-74.7%)
    Bilateral painYes28/36, 77.8%
    (60.8-89.9%)    		2/12, 16.7%
    (2.1-48.4%)    		57.8%
    (30.1-78.8%)
    No56/66, 84.8%
    (73.9-92.5%)    		10/34, 29.4%
    (15.1-47.5%)    		54.3%
    (36.1-70.5%)
    All84/102, 82.4%
    (73.6-89.2%)    		12/46, 26.1%
    (14.3-41.1%)    		55.4%
    (40.1-69.1%)

    • ↵* Point estimate (95% posterior credible interval).

  • Table 4

    Threshold-level improvements in VAS SIJ pain and ODI attributable to the assigned treatment over time.

    VAS SIJ PainODI
    Improvement >20 Points, t/n (%)*Improvement > 25 Points or Rating < 35 points, t/n (%)Improvement > 15 Points, t/n (%)Improvement > 18.8 points, t/n (%)
    MonthsSIJFNSMSIJFNSMSIJFNSMSIJFNSM
    184/100 (84.0%)13/45 (28.9%)79/100 (79.0%)11/45 (24.4%)49/100 (49.0%)6/45 (13.3%)44/100 (44.0%)3/45 (6.7%)
    387/100 (87.0%)17/43 (39.5%)84/100 (84.0%)13/43 (30.2%)72/100 (72.0%)13/43 (30.2%)64/100 (64.0%)10/43 (23.3%)
    684/101 (83.2%)12/43 (27.9%)80/101 (79.2%)8/43 (18.6%)74/101 (73.3%)6/44 (13.6%)63/101 (62.4%)5/44 (11.4%)
    1281/100 (81.0%)4/40 (10%)79/100 (79.0%)3/40 (7.5%)72/100 (72.0%)3/40 (7.5%)66/100 (66.0%)2/40 (5%)
    2474/89 (83.1%)4/40 (10%)73/89 (82.0%)4/40 (10%)60/88 (68.2%)3/40 (7.5%)58/88 (65.9%)3/40 (7.5%)

    • ↵* t = number who had threshold change, n = number evaluated.

  • Table 5

    Adverse events related to device or procedure in SIJF group (n = 102 subjects).

    Event TypeN (%)*
    Finding**
    Fracture
    Neuropathy
    Pain
    Post-operative***
    Wound
    Total    		2 (2%)
    1 (1%)
    1 (1%)
    9 (9%)
    4 (4%)
    5 (5%)
    22 (23%)

    • ↵* Percent reported as number of events divided by number assigned to treatment

    • ↵** Physical examination or radiographic finding

    • ↵*** Postoperative issue, such as urinary retention, nausea/vomiting, atrial fibrillation.

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Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction
David W. Polly, John Swofford, Peter G. Whang, Clay J. Frank, John A. Glaser, Robert P. Limoni, Daniel J. Cher, Kathryn D. Wine, Jonathan N. Sembrano, and the INSITE Study Group
International Journal of Spine Surgery Jan 2016, 10 28; DOI: 10.14444/3028
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