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Sacroiliac Joint Fusion With iFuse Implant System (SIFI) (SIFI)

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ClinicalTrials.gov Identifier: NCT01640353
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Degenerative Sacroiliitis
Sacroiliac Joint Disruption
Enrollment 194
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description SI Joint Fusion with iFuse implant system
Period Title: Overall Study
Started 194
Treated 172
Month 1 171
Month 3 169
Month 6 168
Month 12 160
Month 18 150
Completed 149
Not Completed 45
Reason Not Completed
Withdrew prior to treatment             10
Withdrawn from analysis at term site             12
Withdrawal by Subject             5
Death             2
Early site termination             3
Lost to Follow-up             12
Physician Decision             1
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description SI Joint Fusion with iFuse implant system
Overall Number of Baseline Participants 172
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 172 participants
50.9
(23.5 to 71.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
Female
120
  69.8%
Male
52
  30.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
Hispanic or Latino
7
   4.1%
Not Hispanic or Latino
165
  95.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   0.6%
Black or African American
2
   1.2%
White
166
  96.5%
More than one race
0
   0.0%
Unknown or Not Reported
3
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 172 participants
172
Baseline SIJ pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 172 participants
79.8  (12.8)
[1]
Measure Description: The Visual Analog Scale (VAS) is a 100 mm line on which the subjects mark their pain rating. 0= no pain and 100= worst pain imaginable.
Baseline ODI   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 172 participants
55.2  (11.5)
[1]
Measure Description: Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. If all sections are answered, the total possible score is 50/50 = 100% which is the worst disability possible on the scale. (0/50 = no disability at all.) If any section is skipped by the study participant, the total possible score for that section is removed from the denominator. Example - section 8 skipped, total possible score is 45/45 = 100%.
Baseline EQ-5D   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 172 participants
.43  (0.18)
[1]
Measure Description: EuroQoL-5D (EQ-5D) is a standardized instrument to measure health state. It is a single index value for health status. A score of 0 would = worst imaginable health state while a score of 1.0 would be best imaginable health state.
Baseline SF-36 PCS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 172 participants
31.7  (5.6)
[1]
Measure Description: The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. 0% would represent the lowest or worst possible level of functioning while 100% would represent the highest / best possible level of functioning.
SF-36 MCS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 172 participants
38.5  (11.3)
[1]
Measure Description: The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The MCS is the Mental Component Summary score. 0% would represent the lowest or worst possible level of functioning while 100% would represent the highest / best possible level of functioning.
Duration of prior pain  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 172 participants
5.1
(0.43 to 41.08)
1.Primary Outcome
Title Subject Success
Hide Description Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 194 subjects who were eligible and signed informed consent, 10 voluntarily withdrew prior to SIJF. All data from 12 subjects at a single center were excluded due to early termination of the site. 172 subjects were treated. 168 had 6 months of follow up.
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description:
SI Joint Fusion with iFuse implant system
Overall Number of Participants Analyzed 168
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.5
(74.0 to 85.9)
2.Secondary Outcome
Title Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
148 subjects had SIJ pain scores at 24 months.
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description:
SI Joint Fusion with iFuse implant system
Overall Number of Participants Analyzed 148
Mean (Standard Deviation)
Unit of Measure: units on a scale
53.3  (27.6)
3.Secondary Outcome
Title Change in Back Dysfunction
Hide Description Oswestry Disability Index is a validated patient questionnaire aiming to assess low back pain. The computed scores can be 0% to 100%. Lower scores indicate low disability while high scores indicate high disability. There are 10 questions on the questionnaire. Each has 6 possible answers (0 points - 5 points). If the question is skipped, it's points are subtracted from the denominator. If the raw score is 30 and all 10 questions were answered, the calculation would be 30 / 50 = 60%. If one question was skipped, it would be 30 / 45 = 67%.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
147 of participants had ODI at 24 months post-operatively.
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description:
SI Joint Fusion with iFuse implant system
Overall Number of Participants Analyzed 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
24.5  (21.1)
4.Secondary Outcome
Title Change in Quality of Life
Hide Description Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits
Time Frame Baseline and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
148 participants had QOL information at 24 months post-operatively.
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description:
SI Joint Fusion with iFuse implant system
Overall Number of Participants Analyzed 148
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF36 PCS 8.9  (10.6)
SF36 MCS 10.1  (11.8)
EQ5D TTO .27  (.26)
5.Secondary Outcome
Title Ambulatory Status
Hide Description Percentage of population fully ambulatory at 24 months post operatively.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
148 participants had ambulatory status at 24 month post-operatively
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description:
SI Joint Fusion with iFuse implant system
Overall Number of Participants Analyzed 148
Measure Type: Number
Unit of Measure: percentage of participants
89.2
6.Secondary Outcome
Title Work Status
Hide Description Proportion of non-working subjects who return to work
Time Frame Basline, 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with work status data at 24 months post-operatively who were not working due to back pain (at baseline 37.4% were not working due to back pain).
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description:
SI Joint Fusion with iFuse implant system
Overall Number of Participants Analyzed 148
Measure Type: Number
Unit of Measure: percentage of participants
25.0
7.Secondary Outcome
Title Serious Adverse Events
Hide Description Occurrence of adverse events meeting the ISO14155:2011 definition of serious occurring during the procedure, at the time of hospital discharge (typically day of or next day after procedure), and at various times in late follow-up.
Time Frame Procedure, discharge, 1,3,6,12,18 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
149 participants had 24 months of follow up post-operatively.
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description:
SI Joint Fusion with iFuse implant system
Overall Number of Participants Analyzed 149
Measure Type: Number
Unit of Measure: serious adverse event
100
Time Frame 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sacroiliac Joint Fusion
Hide Arm/Group Description SI Joint Fusion with iFuse implant system
All-Cause Mortality
Sacroiliac Joint Fusion
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sacroiliac Joint Fusion
Affected / at Risk (%) # Events
Total   67/172 (38.95%)    
Cardiac disorders   
Suproventricular tachycardia   1/172 (0.58%)  1
Syncope with dizziness   1/172 (0.58%)  1
MI fatal   1/172 (0.58%)  1
cardiac failure septal defect   1/172 (0.58%)  1
Sinus tachycardia   1/172 (0.58%)  1
Atrial flutter   1/172 (0.58%)  1
Endocrine disorders   
Hypercalcemia   1/172 (0.58%)  1
Gastrointestinal disorders   
Bowel obstruction   2/172 (1.16%)  2
GI bleed   1/172 (0.58%)  1
Prolapsing hemorrhoids   1/172 (0.58%)  1
Constipation   1/172 (0.58%)  1
Dehydration   1/172 (0.58%)  1
General disorders   
Morbid obesity   1/172 (0.58%)  1
Dry mouth associated tooth decay   1/172 (0.58%)  1
Hepatobiliary disorders   
Cholecystitis   2/172 (1.16%)  2
Choledocholithiasis   1/172 (0.58%)  1
Immune system disorders   
Appendicitis   2/172 (1.16%)  2
Anaphylaxis   1/172 (0.58%)  1
Arthritis - thumb   1/172 (0.58%)  1
Infections and infestations   
Wound infection post other surgery   2/172 (1.16%)  2
Infection around pain pump   1/172 (0.58%)  1
Systemic viral infection   1/172 (0.58%)  1
Injury, poisoning and procedural complications   
Revision - SIJ pain   3/172 (1.74%)  3
Surgery site pain   1/172 (0.58%)  1
Revision - fusion hardware pressing on SIJF implants   1/172 (0.58%)  1
Revision - neuropathy post op   2/172 (1.16%)  2
Wound infection / irritation   1/172 (0.58%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis of the knee   1/172 (0.58%)  1
Degenerative disease - spine   12/172 (6.98%)  12
Degenerative disease - knee   1/172 (0.58%)  1
Contralateral SIJ pain   8/172 (4.65%)  8
Ipsilateral SIJ pain   1/172 (0.58%)  1
Degenerative disease - Hip   1/172 (0.58%)  1
Back pain   5/172 (2.91%)  5
Rotator cuff tear   3/172 (1.74%)  3
Neck pain   2/172 (1.16%)  2
Foot pain   1/172 (0.58%)  1
Wrist fracture   1/172 (0.58%)  1
Shoulder pain   3/172 (1.74%)  3
Multiple fractures and concussion MVA   1/172 (0.58%)  1
Hammer toe   1/172 (0.58%)  1
Osteoarthritis of the hip   2/172 (1.16%)  2
Humerus fracture   1/172 (0.58%)  1
Vertebral compression fracture   2/172 (1.16%)  2
Ipsilateral leg pain   1/172 (0.58%)  1
Degerative disease - shoulder   1/172 (0.58%)  2
Back pain from fractured pedicle screws   1/172 (0.58%)  2
Dislocated shoulder   1/172 (0.58%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Esophageal cancer   1/172 (0.58%)  1
Cervical cancer   1/172 (0.58%)  1
Lung cancer   1/172 (0.58%)  1
Nervous system disorders   
Lacunar stroke   1/172 (0.58%)  1
Cerebral infarction   1/172 (0.58%)  1
Intracranial aneurysm   1/172 (0.58%)  1
Psychiatric disorders   
Suicide   1/172 (0.58%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia   3/172 (1.74%)  3
Vascular disorders   
DVT - protein S deficient   1/172 (0.58%)  1
Worsened arthrosclerosis   1/172 (0.58%)  1
Pulmonary embolism with pneumonia   1/172 (0.58%)  1
Pulmonary embolism   1/172 (0.58%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sacroiliac Joint Fusion
Affected / at Risk (%) # Events
Total   153/172 (88.95%)    
Blood and lymphatic system disorders   
Transient WBC elevation   1/172 (0.58%)  1
Bilateral LE edema   1/172 (0.58%)  1
Chronic lymphocytic leukemia   1/172 (0.58%)  1
Cardiac disorders   
Hypertension   1/172 (0.58%)  1
Edema on leg   1/172 (0.58%)  1
Tachycardia   1/172 (0.58%)  1
Angina   1/172 (0.58%)  1
Sinus tachycardia   1/172 (0.58%)  1
Pericarditis   1/172 (0.58%)  1
Ear and labyrinth disorders   
Ear pain - eustachian tube problem   1/172 (0.58%)  1
Endocrine disorders   
Type 2 diabetes   1/172 (0.58%)  1
Hypercholesterolemia   2/172 (1.16%)  2
Osteopenia   1/172 (0.58%)  1
Diabetes mellitus   1/172 (0.58%)  1
Hypercalcemia   1/172 (0.58%)  1
Osteoporosis   1/172 (0.58%)  1
Eye disorders   
Cataracts   2/172 (1.16%)  2
Corneal abrasion   1/172 (0.58%)  1
Gastrointestinal disorders   
Nausea   1/172 (0.58%)  1
Constipation   1/172 (0.58%)  1
Dehydration   1/172 (0.58%)  1
Hiatal hernia   1/172 (0.58%)  1
Acid reflux   1/172 (0.58%)  1
Bacterial gastroenteritis   1/172 (0.58%)  1
General disorders   
Abdominal pain   1/172 (0.58%)  1
Removal of pain pump   1/172 (0.58%)  1
Spontaneous miscarriage   1/172 (0.58%)  1
Fatigue   1/172 (0.58%)  1
Hepatobiliary disorders   
Elevated liver enzymes   1/172 (0.58%)  1
Immune system disorders   
Rheumatoid arthritis   2/172 (1.16%)  2
Eczema   1/172 (0.58%)  1
Arthritis - hands   1/172 (0.58%)  1
Arthritis - ankles   1/172 (0.58%)  1
Allergic rhinitis   1/172 (0.58%)  1
Pruritis drug reaction   1/172 (0.58%)  1
Infections and infestations   
Sinusitis   3/172 (1.74%)  4
Wound seroma after pain pump removal   1/172 (0.58%)  1
Shingles   1/172 (0.58%)  1
Infection at flu shot site   1/172 (0.58%)  1
Cellulitis on leg   1/172 (0.58%)  1
Injury, poisoning and procedural complications   
Nausea   3/172 (1.74%)  3
Intraoperative hemorrhage 800cc   1/172 (0.58%)  1
Surgery site pain   1/172 (0.58%)  1
Right foot weakness   1/172 (0.58%)  1
Wound infection / irritation   5/172 (2.91%)  5
Revision - SIJ pain   1/172 (0.58%)  1
Incision site numbness   1/172 (0.58%)  1
Musculoskeletal and connective tissue disorders   
Back pain   34/172 (19.77%)  37
Foot fracture   2/172 (1.16%)  2
Thigh pain   3/172 (1.74%)  3
Buttock pain   19/172 (11.05%)  20
Cervical stenosis   3/172 (1.74%)  3
Cervical radiculopathy   1/172 (0.58%)  1
Shoulder pain   3/172 (1.74%)  3
Tibial plateau stress fracture   1/172 (0.58%)  1
Ipsilateral SIJ pain   21/172 (12.21%)  24
Degenerative disease - spine   28/172 (16.28%)  33
Contralateral SIJ pain   18/172 (10.47%)  19
Hip pain   9/172 (5.23%)  9
Knee pain   7/172 (4.07%)  7
Back muscle spasms   1/172 (0.58%)  1
Degenerative disease - hip   3/172 (1.74%)  3
Iliotibial band syndrome   1/172 (0.58%)  1
Trochanteric bursitis   9/172 (5.23%)  10
Swelling behind left knee   1/172 (0.58%)  1
Ankle strain   1/172 (0.58%)  1
Rotator cuff tear   1/172 (0.58%)  1
hamstring tear   1/172 (0.58%)  1
Piriformis syndrome   4/172 (2.33%)  4
Leg, hip, groin pain   1/172 (0.58%)  1
Revision - SIJ pain   1/172 (0.58%)  1
Meniscal tear   1/172 (0.58%)  1
Osteoarthritis of the wrist   1/172 (0.58%)  1
Wrist fusion surgery implant problem   1/172 (0.58%)  1
Neck pain   3/172 (1.74%)  3
Calf pain   2/172 (1.16%)  2
Back pain due to broken lumbar fusion screws   1/172 (0.58%)  1
Supraspinatus tear   1/172 (0.58%)  1
Tennis elbow   2/172 (1.16%)  3
Elbow pain   2/172 (1.16%)  2
Osteomyelitis of jaw   1/172 (0.58%)  1
Radial head fracture   1/172 (0.58%)  1
Foot pain   2/172 (1.16%)  2
Wrist pain from punching hard object   1/172 (0.58%)  1
AVN - hip   2/172 (1.16%)  3
Leg pain   1/172 (0.58%)  1
Diastasis recti   1/172 (0.58%)  1
Numbness thigh / foot contralateral   1/172 (0.58%)  1
Chest wall pain   1/172 (0.58%)  1
Calf contusion   2/172 (1.16%)  2
Labral tear bilaterally   1/172 (0.58%)  1
Right L5 radicular pain   1/172 (0.58%)  1
Restless leg syndrome   1/172 (0.58%)  1
Worsened knee extension   1/172 (0.58%)  1
Ischial tuberosity pain   2/172 (1.16%)  2
Knee stiffness   1/172 (0.58%)  1
Iliac crest fibrosis hip pain   1/172 (0.58%)  1
Groin pain   3/172 (1.74%)  3
Contralateral SIJ degeneration   1/172 (0.58%)  1
Flexor sheath cyst in finger   1/172 (0.58%)  1
Humerus tuberosity fracture   1/172 (0.58%)  1
Lumbar myofascial pain   1/172 (0.58%)  1
Ankle jerk   1/172 (0.58%)  1
Myofascial pain   1/172 (0.58%)  1
Osteoarthritis of the hip   1/172 (0.58%)  1
Back and neck pain   1/172 (0.58%)  1
Cervical spondylosis   1/172 (0.58%)  1
Cervical myelopathy   2/172 (1.16%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Numbness related to syringomyelia   1/172 (0.58%)  1
Nervous system disorders   
Low sensation / strength left leg   1/172 (0.58%)  1
Foot drop - left   1/172 (0.58%)  1
Ankle dorsiflexion   1/172 (0.58%)  1
Contralateral leg weakness   1/172 (0.58%)  1
Foot numbness bilateral   1/172 (0.58%)  1
Migraine   2/172 (1.16%)  2
Fibromyalgia   2/172 (1.16%)  2
Leg numbness   1/172 (0.58%)  1
Foot numbness   1/172 (0.58%)  1
Loss of consciousness   1/172 (0.58%)  1
Hit head   1/172 (0.58%)  1
Diabetic neuropathy   1/172 (0.58%)  1
Right leg weakness   1/172 (0.58%)  1
Left leg sensory   1/172 (0.58%)  1
Bilateral leg neuropathic pain   1/172 (0.58%)  1
Ipsilateral thigh pain   1/172 (0.58%)  1
Transient ischemic attack   1/172 (0.58%)  1
Confusion   1/172 (0.58%)  1
L5 sensory   1/172 (0.58%)  1
Contralateral leg numbness and pain   1/172 (0.58%)  1
Psychiatric disorders   
Anxiety   1/172 (0.58%)  1
Xanax withdrawal   1/172 (0.58%)  1
Drug addiction   1/172 (0.58%)  1
Renal and urinary disorders   
Kidney stone   3/172 (1.74%)  3
UTI   5/172 (2.91%)  5
Urinary retention   1/172 (0.58%)  1
Hematuria   1/172 (0.58%)  1
Urge incontinence   1/172 (0.58%)  1
Respiratory, thoracic and mediastinal disorders   
Upper respiratory infection   7/172 (4.07%)  7
Bronchitis   3/172 (1.74%)  3
Pneumonia   3/172 (1.74%)  3
Skin and subcutaneous tissue disorders   
Allergic dermatitis to tape   1/172 (0.58%)  2
Finger laceration   1/172 (0.58%)  1
Thumb laceration   1/172 (0.58%)  1
Hair loss   1/172 (0.58%)  1
Vascular disorders   
Abdominal aortic aneurysm   1/172 (0.58%)  1
Wound bleed post cervical fusion   1/172 (0.58%)  1
Indicates events were collected by systematic assessment
Lack of concurrent control group undergoing non-surgical treatment and a 24-month follow up rate that was not as high as desired.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the site is that the sponsor can review results communications prior to public release and must have at least 30 days to do so.
Results Point of Contact
Name/Title: Daniel Cher, MD, Vice President of Clinical Affairs
Organization: SI-BONE, Inc.
Phone: 650-269-5763
Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT01640353     History of Changes
Other Study ID Numbers: 300101
First Submitted: July 6, 2012
First Posted: July 13, 2012
Results First Submitted: July 11, 2016
Results First Posted: March 24, 2017
Last Update Posted: March 24, 2017