Research ArticleArticles

Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial

Bradley S. Duhon, Fabien Bitan, Harry Lockstadt, Don Kovalsky, Daniel Cher, Travis Hillen and on behalf of the SIFI Study Group
International Journal of Spine Surgery January 2016, 10 13; DOI: https://doi.org/10.14444/3013

Article Figures & Data

Figures

  • Fig. 1
    Fig. 1

    Patient study flow.

  • Fig. 2
    Fig. 2

    Improvement in VAS SI joint pain (top) and Oswestry Disability Index (bottom). Numbers in blue indicate the number of subjects assessed. ODI was not assessed at month 18.

  • Fig. 3
    Fig. 3

    Changes in EQ-5D time trade-off index and visual analog scale (top row), SF-36 PCS and MCS (middle row) and SF-36 individual dimensions (norm-based scale). Dotted lines show population medians (top row) or means (middle and bottom row) and 25th/75th percentiles (top row), 1 SD (middle and bottom row). In the bottom row, solid=baseline, dashed= 6 months, dotted=12 months, dot-dashed=24 months.

  • Fig. 4
    Fig. 4

    Changes by month in ambulatory status (top left), work status (top right), global pain assessment (middle left), activities of daily living (middle right) and opioid use (bottom, proportion ± 95% confidence interval).

Tables

  • Supplementary Table 1

    Patients included but who did not meet all study eligibility requirements.

    ReasonN
    Receiving disability payments9
    Involvement in litigation claims3
    Osteoporosis3
    Rheumatologic disease1
    Severe concomitant back pain1
    SI joint pain score too low3
    Age > 701
    Total21
  • Table 1

    Characteristics of enrolled subjects.

    CharacteristicValue
    Age, mean (range)50.9 (23.5 - 71.6)
    Women, n (% female)120 (69.8%)
    Race, n (%)
    White
    Hawaiian / Pacific Islander
    Black
    Other
    166 (96.5%)
    1 (0.6%)
    2 (1.2%)
    3 (1.7%)
    Ethnicity
    Hispanic or Latino, n (%)
    7 (4.1%)
    Body mass index, mean (range)29.4 (17.2 - 51.0)
    Smoking status, n (%)
    Current smoker
    Former smoker
    Never smoker
    Ambulatory without assistance (n,%)
    44 (25.6%)
    49 (28.5%)
    79 (45.9%)
    154 (89.5%)
    Work status (n,%)
    Working full time
    Working part time
    Not working, retired
    Not working due to back pain
    Not working, other reason
    Prior lumbar fusion (n,%)
    64 (37.2%)
    9 (5.2%)
    35 (20.3%)
    60 (34.9%)
    4 (2.3%)
    76 (44.2%)
    Underlying diagnosis
    Degenerative sacroiliitis
    Sacroiliac joint disruption
    Years of pain, mean (range)
    135 (78.5%)
    37 (21.5%)
    5.1 (0.43-41.08)
    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
    20 (11.6%)
    144 (83.7%)
    96 (55.8%)
    151 (87.8%)
    137 (79.7%)
    153 (89.0%)
    150 (87.2%)
    117 (68.0%)
    Prior treatments
    Physical therapy
    Steroid SI joint injection
    RF ablation
    Taking narcotics (n,%)
    Proportion with lumbar stenosis (n,%)
    Proportion with hip diagnosis (n,%)
    111 (64.5%)
    162 (94.2%)
    27 (15.7%)
    131 (76.2%)
    42 (24.4%)
    24 (14.0%)
  • Table 2

    Index procedure characteristics (n=172). Only the index side procedure is reported.

    Procedure duration, minutes, mean (SD), range46.6 (16.1), 13-111
    Fluoroscopy duration, minutes, mean (SD), range2.7 (1.8), 0.3-13.5
    Estimated blood loss, cc, mean (SD), range51.0 (75.8), 5-800
    Number of implants used, N (%)
    2
    3
    4
    6 (3.5%)
    144(83.7%)
    22 (12.8%)
  • Table 3

    Change over time in SI joint pain, Oswestry Disability Index, SF-36, and EQ-5D.

    Time pointMean (SD)Improvement from Baseline, Mean (SD)P-value*
    VAS SI joint pain
    Baseline
    Month 1
    Month 3
    Month 6
    Month 12
    Month 18
    Month 24
    79.8 (12.8)
    37.0 (26.3)
    30.7 (25.9)
    30.0 (26.5)
    30.4 (27.6)
    28.1 (27.8)
    26.0 (26.7)
    -
    42.7 (28.5)
    49.2 (25.6)
    49.9 (28.3)
    49.3 (29.5)
    51.5 (28.8)
    53.3 (27.6)    		<.0001
    Oswestry Disability Index
    Baseline
    Month 1
    Month 3
    Month 6
    Month 12
    Month 24
    55.2 (11.5)
    42.6 (17.4)
    33.8 (18.8)
    32.5 (19.7)
    31.5 (19.2)
    30.9 (20.5)
    -
    12.5 (19.2)
    21.3 (19.2)
    22.7 (20.6)
    23.8 (20.6)
    24.5 (21.1)    		<.0001
    SF-36 PCS
    Baseline
    Month 6
    Month 12
    Month 24

    SF-36 MCS
    Baseline
    Month 6
    Month 12
    Month 24
    31.7 (5.6)
    40.1 (9.6)
    40.5 (9.6)
    40.7 (10.3)


    38.5 (11.3)
    47.8 (11.6)
    48.2 (12.3)
    49.0 (11.5)
    -
    8.3 (9.7)
    8.8 (9.8)
    8.9 (10.6)


    -
    9.3 (12.7)
    9.5 (11.8)
    10.1 (11.8)    		<.0001





    <.0001
    EQ-5D TTO
    Baseline
    Month 6
    Month 12
    Month 24
    0.43 (0.18)
    0.69 (0.21)
    0.71 (0.20)
    0.71 (0.22)
    -
    0.25 (0.24)
    0.27 (0.24)
    0.27 (0.26)    		<.0001

    • ↵* Repeated measures analysis of variance compared to baseline

  • Supplementary Table 2

    Listing of adverse events by frequency.

    EventN%
    Contralateral SI joint pain2011.6
    SI joint pain148.1
    Trochanteric bursitis84.7
    Buttock pain74.1
    Upper respiratory infection74.1
    Fall causing back pain63.5
    Pneumonia63.5
    SI joint pain63.5
    Urinary tract infection52.9
    Knee pain42.3
    Back pain31.7
    Fall causing SI joint pain31.7
    Fall causing shoulder pain31.7
    Sinusitis31.7
    Wound infection31.7
    Acute appendicitis21.2
    Avascular necrosis of hip21.2
    Basilar artery occlusion causing stroke21.2
    Bronchitis21.2
    Cataracts21.2
    Cholecystitis21.2
    Degenerative joint disease of shoulder21.2
    Facet arthropathy with low back pain21.2
    Fall causing SI joint pain21.2
    Fall causing buttock pain21.2
    Fall causing calf contusion21.2
    Fall causing contralateral SI joint pain21.2
    Fall causing hip pain21.2
    Fall causing humerus fracture21.2
    Hip pain due to osteoarthritis21.2
    Hypercalcemia21.2
    Hypercholesterolemia21.2
    Ischial tuberosity pain21.2
    Lateral epicondylitis21.2
    Low back pain of unknown cause21.2
    Lower back pain due to lumbar spine degeneration21.2
    Lumbar facet pain21.2
    Migraine headache21.2
    Motor vehicle accident21.2
    Nephrolithiasis21.2
    Postoperative iFuse neuropathy21.2
    Postoperative nausea21.2
    Rheumatoid arthritis21.2
    Abdominal and hip pain, cause unknown10.6
    Acid reflux / helicobacter infection10.6
    Acute bronchitis10.6
    Acute confusion, cause unknown10.6
    Acute sinusitis10.6
    Allergic dermatitis due to surgical tape10.6
    Allergic reaction to wound tape10.6
    Allergic rhinitis10.6
    Anaphylaxis10.6
    Ankle pain due to arthritis10.6
    Anterior thigh pain of unknown origin10.6
    Anxiety10.6
    Aortic aneurysm10.6
    Arm/leg pain due to cervical stenosis10.6
    Asymptomatic right leg weakness on physical exam10.6
    Atrial flutter10.6
    Avascular necrosis of hip (bilateral)10.6
    Back and PSIS pain unknown cause10.6
    Back and SI joint pain due to thoracolumbar intervertebral disc degeneration10.6
    Back and SI joint pain, possible piriformis syndrome10.6
    Back and contralateral SI joint pain10.6
    Back pain due to L4-5 degeneration10.6
    Back pain due to L5-S1 degeneration10.6
    Back pain due to degenerative disc disease10.6
    Back pain due to degenerative lumbar disc disease10.6
    Back pain due to degenerative lumbar scoliosis10.6
    Back pain due to disc degeneration10.6
    Back pain due to fractured pedicle screws10.6
    Back pain due to known degenerative disc disease10.6
    Back pain due to lumbar facet disorder and lumbar spondylosis10.6
    Back pain due to lumbar screw failure10.6
    Back pain due to lumbar strain10.6
    Back pain due to mild trauma10.6
    Back pain due to spondylolisthesis10.6
    Back pain due to spondylolysis and spondylolisthesis10.6
    Back pain due to trigger point injection10.6
    Back pain from L5/S1 pseudoarthrosis and screw breakage10.6
    Back pain from minor trauma resulting in thoracolumbar fusion10.6
    Back pain from severe L5/S1 disc herniation10.6
    Back pain from sneeze10.6
    Back pain possibly due to failed prior lumbar fusion10.6
    Back pain possibly due to prior L3/4 surgery10.6
    Back pain possibly related to a previous L4-L5 discectomy10.6
    Back pain related to DDD and facet arthritis10.6
    Back pain related to lumbar disc degeneration10.6
    Back pain related to prior lumbar fusion10.6
    Back/leg pain due to L4-5 stenosis and spondylolisthesis10.6
    Bacterial gastroenteritis10.6
    Bilateral SI joint pain requiring revision10.6
    Bilateral ear pain, suspected eustachian tube malfunction10.6
    Bilateral foot numbness of unknown cause10.6
    Bilateral hip labral tear on MRI10.6
    Bilateral leg neuropathic pain10.6
    Bilateral lower extremity edema10.6
    Bleeding from cervical fusion wound10.6
    Bothersome surgical pain pump10.6
    Bowel obstruction10.6
    Buttock and leg pain10.6
    Buttock pain due to lifting heavy object10.6
    Buttock pain from irritation of nerve root by disc herniation10.6
    Calf/heel pain10.6
    Car accident causing lateral epicondylitis10.6
    Cervical cancer recurrence10.6
    Cervical myelopathy10.6
    Cervical radicular pain10.6
    Cervical radiculopathy10.6
    Chest pain10.6
    Choledocholithiasis10.6
    Chondromalacia of knee10.6
    Chronic lymphocytic leukemia10.6
    Constipation10.6
    Contralateral SI joint pain requiring fusion redo10.6
    Contralateral back and buttock pain10.6
    Contralateral back pain related to prior L5/S1 fusion10.6
    Contralateral buttock pain due to PT10.6
    Contralateral buttocks pain10.6
    Contralateral calf pain10.6
    Contralateral hip/back pain10.6
    Contralateral knee pain10.6
    Contralateral knee stiffness10.6
    Contralateral leg numbness and pain10.6
    Contralateral neck/arm pain due to cervical arthritis10.6
    Corneal abrasion10.6
    Decreased ankle jerk on physical exam10.6
    Decreased sensation and strength in ipsilateral leg10.6
    Deep venous thrombosis10.6
    Deep wound infection related to SI joint fusino10.6
    Degenerative disc disease L1/L210.6
    Dehydration after contralateral SI joint fusion10.6
    Diabetes mellitus10.6
    Diastasis Recti10.6
    Drug addiction rehabilitation10.6
    Drug allergy10.6
    Dry mouth causing tooth decay10.6
    Eczema flare-up10.6
    Elbow pain10.6
    Elevated liver enzymes of unknown etiology10.6
    Episode of shingles10.6
    Esophageal cancer10.6
    Facet degeneration at C4-5 and C5-610.6
    Fall causing SI joint pain. Poor device placement.10.6
    Fall causing ankle pain10.6
    Fall causing back and sacral pain10.6
    Fall causing buttock and hip pain10.6
    Fall causing buttock, back and neck pain10.6
    Fall causing buttocks and hip pain10.6
    Fall causing contralateral SI joint and back pain10.6
    Fall causing dislocated shoulder10.6
    Fall causing foot and hand fracture10.6
    Fall causing foot fracture10.6
    Fall causing hip and back pain10.6
    Fall causing hip/leg pain10.6
    Fall causing knee meniscal injury10.6
    Fall causing knee pain10.6
    Fall causing pain in back, buttock and neck10.6
    Fall causing radial head fracture10.6
    Fall causing shoulder rotator cuff injury10.6
    Fall causing shoulder, body, hip and knee pain10.6
    Fall causing wrist fracture10.6
    Fall worsening pain related to lumbar hardware10.6
    Fatal myocardial infarction10.6
    Fatigue/generalized weakness of unknown cause10.6
    Fibromyalgia10.6
    Flexor sheath cyst on finger10.6
    Foot pain10.6
    Foot pain due to torn tendon10.6
    Gastrointestinal bleeding10.6
    Hair loss10.6
    Hammer toe10.6
    Hamstring tear10.6
    Hand arthritis10.6
    Heart failure due to ventricular septal defect10.6
    Hematuria of unknown cause10.6
    Hiatal hernia10.6
    Hip and buttock pain10.6
    Hip arthritis requiring hip replacement10.6
    Hip bursitis10.6
    Hip pain10.6
    Hip pain after hip replacement10.6
    Hip pain due to fibrosis10.6
    Hip pain due to hip joint osteoarthritis10.6
    Hip pain of unknown cause10.6
    Hip/leg pain, possible piriformis syndrome10.6
    Hypertension exacerbation due to medication non-compliance10.6
    Hypotension related to dehydration10.6
    Iliotibial band syndrome10.6
    Infection left arm related to flu shot10.6
    Infection of implanted pain pump10.6
    Inguinal pain of unknown origin10.6
    Injury from spousal physical abuse causing back pain10.6
    Intermittent contralateral hip and buttock pain10.6
    Intermittent hip and buttock swelling10.6
    Intracranial aneurysm10.6
    Intraoperative hemorrhage10.6
    Ipisilateral thigh pain10.6
    Ipsilateral buttock pain10.6
    Ipsilateral buttocks pain10.6
    Ipsilateral hip pain10.6
    Ipsilateral knee pain due to patellofemoral arthritis10.6
    Ipsilateral leg numbness possibly due to degenerative disc disease10.6
    Ipsilateral leg pain due to prior lumbar fusion10.6
    Jaw osteomyelitis10.6
    Knee pain due to twisting injury10.6
    Knee swelling of unknown cause10.6
    L3-4 vertebral fractures due to coughing10.6
    L5 radiculopathy due to lumbar disc bulge10.6
    L5 sensory neuropathy10.6
    Lateral thigh pain unknown cause10.6
    Left groin pain related to ”left groin pull”10.6
    Leg cellulitis10.6
    Leg edema due to pneumonia hospitalization10.6
    Leg numbness possibly related to OR positioning10.6
    Leg pain10.6
    Leg pain due to piriformis syndrome10.6
    Leg pain due to possible disc bulge10.6
    Leg pain possibly due to hip osteoarthritis or lumbar disc10.6
    Leg sensory exam deficit related to epidural stimulator10.6
    Leg weakness of unknown cause10.6
    Limited knee extension related to old injury10.6
    Loosening of wrist implants after wrist fusion surgery10.6
    Loss of balance causing fall10.6
    Loss of consciousness due to supraventricular tachycardia10.6
    Low back and buttock pain10.6
    Low back and hip pain10.6
    Low back and radicular pain possibly due to prior lumbar fusion10.6
    Low back due to degenerative disc disease, spinal stenosis and SI joint dysfunction10.6
    Low back pain10.6
    Low back pain due to degenerative disc disease (location not known)10.6
    Low back pain due to facet arthritis10.6
    Low back pain due to previously implanted hardware (not iFuse)10.6
    Low back pain related to prior lumbar fusion10.6
    Low back possibly related to mild disc bulge10.6
    Lower back pain due to DDD and annular tear10.6
    Lower back pain due to L5 disc degeneration10.6
    Lower back pain due to lumbar spinal stenosis10.6
    Lumbar myofascial pain10.6
    Lumbar radiculitis, with multiple potential causes10.6
    Lumbar radiculopathy10.6
    Lung cancer diagnosis10.6
    MVA causing back and neck pain10.6
    Medication side effect10.6
    Mid and low back pain related to prior lumbar fusion10.6
    Midback pain due to thoracic degenerative disc disease and T8/9 herniation10.6
    Morbid obesity10.6
    Motor vehicle accident causing elbow pain10.6
    Motor vehicle accident causing loss of consciousness10.6
    Muscle spasms of unknown etiology10.6
    Musculoskeletal chest pain10.6
    Narcotic-induced constipation related to surgery for esophageal cancer10.6
    Nausea/vomiting/constipation related to esophageal cancer and opioid use10.6
    Neck and back pain secondary to nausea and vomiting10.6
    Neck and upper/lower back pain10.6
    Neck pain due to cervical facet arthropathy / fall10.6
    Neck pain due to cervical stenosis10.6
    Neck pain due to herniated C5-610.6
    Neck pain from cervical spondylosis10.6
    Neck pain possibly due to cervical stenosis10.6
    Neck pain related to cervical ACDF10.6
    Neck pain related to prior cervical fusion10.6
    Numbness around surgical wound10.6
    Numbness/tingling in foot10.6
    Osteoarthritis of wrist10.6
    Osteopenia10.6
    Osteoporosis10.6
    Osteoporotic vertebral body compression fracture10.6
    Painful diabetic neuropathy10.6
    Pericarditis10.6
    Piriformis syndrome10.6
    Possible hip pain10.6
    Postoperative iFuse neuropathy after contralateral SI joint fusion redo10.6
    Postoperative ileus10.6
    Postoperative nausea/vomiting10.6
    Postsurgical wound infection (not iFuse)10.6
    Prolapsing hemorrhoids10.6
    Pulmonary embolism10.6
    Pulmonary embolism and pneumonia10.6
    Radicular pain due to lumbar stenosis and previous lumbar surg-eries10.6
    Radicular pain due to spinal stenosis10.6
    Radicular pain from L5/S1 degeneration10.6
    Radiculopathy due to L4-S1 foraminal stenosis10.6
    Radiculopathy due to L4/5 disc degeneration10.6
    Restless leg syndrome10.6
    Right L5 radicular pain and numbness10.6
    Right foot weakness due to nerve injury from regional anesthesia10.6
    Right knee buckling10.6
    Rotator cuff pain10.6
    Rotator cuff tear10.6
    SI joint and leg pain10.6
    SI joint pain due to inadequate placement10.6
    SI joint pain, possibly from periosteal growth around implant10.6
    SI joint pain due to inadequate stabilization10.6
    SI joint pain due to radiolucency around implant10.6
    SI joint pain from irritation of SI joint implant by screw placed during lumbar fusion10.6
    Scapular pain due to cervical radiculopathy/stenosis10.6
    Scapular pain due to prior thoracolumbar fusion10.6
    Shoulder injury due to pulling10.6
    Shoulder labral tear10.6
    Shoulder pain due to bone spur10.6
    Shoulder pain of unknown etiology10.6
    Sinus tachycardia related to WPW syndrome10.6
    Sinus tachycardia, unknown cause10.6
    Spontaneous abortion10.6
    Staple irritation10.6
    Suicide10.6
    Supraspinatus tear10.6
    Symptomatic cervical stenosis10.6
    Symptomatic renal calculus10.6
    Syncope/dizziness10.6
    Systemic viral infection10.6
    Tachycardia10.6
    Thigh and foot numbness due to contralateral SI joint dysfunction10.6
    Thigh numbness due to lumbar radiculopathy10.6
    Thigh pain related to DDD10.6
    Thoracic strain10.6
    Thoracolumbar numbness related to syringomyelia10.6
    Thumb laceration10.6
    Thumb pain due to arthritis10.6
    Tibial plateau stress fracture10.6
    Transient WBC elevation without infection10.6
    Transient ischemic attack10.6
    Trauma causing leg, hip and groin pain10.6
    Trauma to finger10.6
    Twisted foot10.6
    Type 2 diabetes mellitus10.6
    Unclear, SI joint degeneration vs. pain10.6
    Upper back pain due to thoracic disc degeneration10.6
    Urge incontinence10.6
    Urinary retention10.6
    Worsened aortic atherosclerosis found during lumbar fusion surgery10.6
    Worsened cervical myelopathy10.6
    Worsened chronic thoracic pain10.6
    Worsened contralateral SI joint pain10.6
    Worsened left ankle dorsiflexion10.6
    Worsening back pain due to known degeneration of L4-L510.6
    Worsening fibromyalgia10.6
    Worsening lumbar radicular pain10.6
    Wound drainage10.6
    Wound infection after cervical fusion surgery10.6
    Wound seroma10.6
    Wrist injury from trauma10.6
    Xanax withdrawal10.6
  • Table 4

    Device- or procedure-related events.

    Event categoryn(%)b
    Related to devicea
     Neuropathic pain related to device malposition
     SI joint or buttock pain
     SI joint pain after fall associated with inadequate
     device placement
     Hip pain related to periosteal bone growth around implant
    7
    3 (1.8%)
    2 (1.2%)
    1 (0.6%)
    1 (0.6%)
    Related to procedurea26
     Buttock pain
     Foot weakness related to anesthesia
     iFuse impingement
     Nausea/vomiting
     SI joint pain
     SI joint pain (inadequate stabilization)
     Urinary retention
     Vascular injury
     Wound drainage/irritation/infection
     Wound numbness    		2 (1.2%)
    1 (0.6%)
    3 (1.7%)
    3 (1.7%)
    5 (2.9%)
    3 (1.7%)
    1 (0.6%)
    1 (0.6%)
    6 (3.5%)
    1 (0.6%)

    • ↵a Number (rate) of events divided by number undergoing surgical procedure. Some events were related to both device and procedure.

    • ↵b Events rated as probably or definitely related to the device/procedure by the study site investigator.

  • Table 5

    Findings from CT analysis.

    12-Month CT ScanRight (N=92 sides)Left (N=93 sides)
    SacralIliacSacralIliac
    Adherence of bone to implant on 30% or more
     Implant 1
     Implant 2
     Implant 3
     Implant 4
    88 (95.7%)
    89 (96.7%)
    83 (94.3%)
    7 (87.5%)
    90 (97.8%)
    90 (97.8%)
    86 (97.7%)
    8 (100.0%)
    91 (97.8%)
    90 (96.8%)
    86 (93.5%)
    15 (93.8%)
    91 (97.8%)
    91 (97.8%)
    90 (97.8%)
    16 (100.0%)
    At least 30% apposition on both iliac and sacral sides of at least 2 implants90 (97.8%)90 (96.8%)
    Lucency in at least 1 implant
     Absent
     Present
     Unable to assess
    80 (87.9%)
    9 (9.9%)
    2 (2.2%)
    83 (89.2%)
    8 (8.6%)
    2 (2.2%)
    Breach
     Absent
     Present – anterior sacrum
     Present – sacral foramen
     Unable to assess
    85 (93.4%)
    1 (1.1%)
    3 (3.3%)
    2 (2.2%)
    83 (89.2%)
    1 (1.1%)
    7 (7.5%)
    2 (2.2%)
    Device failure
     No
     Yes
     Unable to assess
    89 (97.8%)
    0 (0%)
    2 (2.2%)
    91 (97.8%)
    0 (0%)
    2 (2.2%)
    Device migration*
     Absent
     Present
     Unable to assess
    89 (97.8%)
    0 (0%)
    2 (2.2%)
    91 (97.8%)
    0 (0%)
    2 (2.2%)
    Adverse bone reaction
     Absent
     Present
     Unable to assess
    86 (94.5%)
    3 (3.3%)
    2 (2.2%)
    85 (91.4%)
    6 (6.5%)
    2 (2.2%)
    Bone remodeling
     Absent
     Present
     Unable to assess
    14 (15.4%)
    75 (82.4%)
    2 (2.2%)
    10 (10.8%)
    81 (87.1%)
    2 (2.2%)
    Bridging bone
     Absent
     Present - adjacent and distant
     Present – adjacent
     Present – distant
     Unable to assess
    68 (74.7%)
    2 (2.2%)
    14 (15.4%)
    4 (4.4%)
    3 (3.3%)
    72 (77.4%)
    2 (2.2%)
    11 (11.8%)
    6 (6.5%)
    2 (2.2%)

    • ↵* Defined as movement ≥3 mm.

  • Table 6

    Findings from X-ray analysis.

    3-, 6- and 24-month X-rayMonth 3Month 6Month 24
    Lucency: right
     Absent
     Present
     Not available*
    Lucency: left
     Absent
     Present
     Not available
    65 (75.6%)
    14 (16.3%)
    7 (8.1%)

    70 (80.5%)
    11 (12.6%)
    6 (6.9%)
    53 (60.9%)
    23 (26.4%)
    7 (8.0%)

    65 (72.2%)
    17 (18.9%)
    4 (4.4%)
    47 (52.2%)
    39 (43.3%)
    0 (0%)

    56 (60.9%)
    32 (34.8%)
    92 (100.0%)
    Positive bone reaction: right
     Absent
     Present
     Not available
    Positive bone reaction: left
     Absent
     Present
     Not available
    78 (91.8%)
    0 (0%)
    7 (8.2%)

    81 (91.0%)
    1 (1.1%)
    7 (7.9%)
    73 (84.9%)
    2 (2.3%)
    7 (8.1%)

    80 (88.9%)
    2 (2.2%)
    4 (4.4%)
    71 (78.9%)
    15 (16.7%)
    0 (0%)

    72 (78.3%)
    16 (17.4%)
    0 (0%)
    Device failuresNoneNoneNone
    Device migrationNoneNoneNone
    Adverse bone reactionNoneNoneNone

    • ↵* Not available=X-ray not done.

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Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial
Bradley S. Duhon, Fabien Bitan, Harry Lockstadt, Don Kovalsky, Daniel Cher, Travis Hillen, on behalf of the SIFI Study Group
International Journal of Spine Surgery Jan 2016, 10 13; DOI: 10.14444/3013
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