Trial Outcomes & Findings for Sacroiliac Joint Fusion With iFuse Implant System (SIFI) (NCT NCT01640353)
NCT ID: NCT01640353
Last Updated: 2017-03-24
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.
Recruitment status
COMPLETED
Target enrollment
194 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2017-03-24
Participant Flow
Participant milestones
| Measure |
Sacroiliac Joint Fusion
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Overall Study
STARTED
|
194
|
|
Overall Study
Treated
|
172
|
|
Overall Study
Month 1
|
171
|
|
Overall Study
Month 3
|
169
|
|
Overall Study
Month 6
|
168
|
|
Overall Study
Month 12
|
160
|
|
Overall Study
Month 18
|
150
|
|
Overall Study
COMPLETED
|
149
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Sacroiliac Joint Fusion
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Overall Study
Withdrew prior to treatment
|
10
|
|
Overall Study
Withdrawn from analysis at term site
|
12
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Death
|
2
|
|
Overall Study
Early site termination
|
3
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
Baseline characteristics by cohort
| Measure |
Sacroiliac Joint Fusion
n=172 Participants
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Age, Continuous
|
50.9 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
172 participants
n=5 Participants
|
|
Baseline SIJ pain
|
79.8 units on a scale
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Baseline ODI
|
55.2 units on a scale
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Baseline EQ-5D
|
.43 units on a scale
STANDARD_DEVIATION 0.18 • n=5 Participants
|
|
Baseline SF-36 PCS
|
31.7 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
SF-36 MCS
|
38.5 units on a scale
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Duration of prior pain
|
5.1 Years
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Sacroiliac Joint Fusion
n=168 Participants
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Subject Success
|
80.5 percentage of participants
Interval 74.0 to 85.9
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 148 subjects had SIJ pain scores at 24 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.
Outcome measures
| Measure |
Sacroiliac Joint Fusion
n=148 Participants
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)
|
53.3 units on a scale
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 147 of participants had ODI at 24 months post-operatively.
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%.
Outcome measures
| Measure |
Sacroiliac Joint Fusion
n=147 Participants
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Change in Back Dysfunction
|
24.5 units on a scale
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: 148 participants had QOL information at 24 months post-operatively.
Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits
Outcome measures
| Measure |
Sacroiliac Joint Fusion
n=148 Participants
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Change in Quality of Life
SF36 PCS
|
8.9 units on a scale
Standard Deviation 10.6
|
|
Change in Quality of Life
SF36 MCS
|
10.1 units on a scale
Standard Deviation 11.8
|
|
Change in Quality of Life
EQ5D TTO
|
.27 units on a scale
Standard Deviation .26
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 148 participants had ambulatory status at 24 month post-operatively
Percentage of population fully ambulatory at 24 months post operatively.
Outcome measures
| Measure |
Sacroiliac Joint Fusion
n=148 Participants
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Ambulatory Status
|
89.2 percentage of participants
|
SECONDARY outcome
Timeframe: Basline, 24 monthsPopulation: 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).
Proportion of non-working subjects who return to work
Outcome measures
| Measure |
Sacroiliac Joint Fusion
n=148 Participants
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Work Status
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Procedure, discharge, 1,3,6,12,18 and 24 monthsPopulation: 149 participants had 24 months of follow up post-operatively.
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.
Outcome measures
| Measure |
Sacroiliac Joint Fusion
n=149 Participants
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Serious Adverse Events
|
100 serious adverse event
|
Adverse Events
Sacroiliac Joint Fusion
Serious events: 67 serious events
Other events: 153 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sacroiliac Joint Fusion
n=172 participants at risk
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis of the knee
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative disease - spine
|
7.0%
12/172 • Number of events 12 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative disease - knee
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Contralateral SIJ pain
|
4.7%
8/172 • Number of events 8 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Ipsilateral SIJ pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative disease - Hip
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
5/172 • Number of events 5 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Multiple fractures and concussion MVA
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Hammer toe
|
0.58%
1/172 • 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
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Humerus fracture
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Vertebral compression fracture
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Ipsilateral leg pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Degerative disease - shoulder
|
0.58%
1/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain from fractured pedicle screws
|
0.58%
1/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Dislocated shoulder
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Revision - SIJ pain
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Surgery site pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Revision - fusion hardware pressing on SIJF implants
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Revision - neuropathy post op
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Wound infection / irritation
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Hepatobiliary disorders
Choledocholithiasis
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Bowel obstruction
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
GI bleed
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Prolapsing hemorrhoids
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Dehydration
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
General disorders
Morbid obesity
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
General disorders
Dry mouth associated tooth decay
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Suproventricular tachycardia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Syncope with dizziness
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
MI fatal
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
cardiac failure septal defect
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Atrial flutter
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Vascular disorders
DVT - protein S deficient
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Vascular disorders
Worsened arthrosclerosis
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Vascular disorders
Pulmonary embolism with pneumonia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Vascular disorders
Pulmonary embolism
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Infections and infestations
Wound infection post other surgery
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Infections and infestations
Infection around pain pump
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Infections and infestations
Systemic viral infection
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Immune system disorders
Appendicitis
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Immune system disorders
Anaphylaxis
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Immune system disorders
Arthritis - thumb
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Endocrine disorders
Hypercalcemia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Lacunar stroke
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Cerebral infarction
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Intracranial aneurysm
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal cancer
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical cancer
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Psychiatric disorders
Suicide
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
Other adverse events
| Measure |
Sacroiliac Joint Fusion
n=172 participants at risk
SI Joint Fusion with iFuse implant system
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.8%
34/172 • Number of events 37 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Foot fracture
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Thigh pain
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
11.0%
19/172 • Number of events 20 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical stenosis
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical radiculopathy
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Tibial plateau stress fracture
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Ipsilateral SIJ pain
|
12.2%
21/172 • Number of events 24 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative disease - spine
|
16.3%
28/172 • Number of events 33 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Contralateral SIJ pain
|
10.5%
18/172 • Number of events 19 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
5.2%
9/172 • Number of events 9 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
4.1%
7/172 • Number of events 7 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Back muscle spasms
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Degenerative disease - hip
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Iliotibial band syndrome
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Trochanteric bursitis
|
5.2%
9/172 • Number of events 10 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Swelling behind left knee
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Ankle strain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
hamstring tear
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Piriformis syndrome
|
2.3%
4/172 • Number of events 4 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Leg, hip, groin pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Revision - SIJ pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Meniscal tear
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis of the wrist
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Wrist fusion surgery implant problem
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Calf pain
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain due to broken lumbar fusion screws
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Supraspinatus tear
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Tennis elbow
|
1.2%
2/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Elbow pain
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis of jaw
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Radial head fracture
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Wrist pain from punching hard object
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
AVN - hip
|
1.2%
2/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Numbness thigh / foot contralateral
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Calf contusion
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Labral tear bilaterally
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Right L5 radicular pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Restless leg syndrome
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Worsened knee extension
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Ischial tuberosity pain
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Knee stiffness
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Iliac crest fibrosis hip pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Contralateral SIJ degeneration
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Flexor sheath cyst in finger
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Humerus tuberosity fracture
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar myofascial pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Ankle jerk
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain
|
0.58%
1/172 • 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
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Back and neck pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical spondylosis
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
General disorders
Abdominal pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
General disorders
Removal of pain pump
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
General disorders
Spontaneous miscarriage
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
General disorders
Fatigue
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Immune system disorders
Rheumatoid arthritis
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Immune system disorders
Eczema
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Immune system disorders
Arthritis - hands
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Immune system disorders
Arthritis - ankles
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Immune system disorders
Allergic rhinitis
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Immune system disorders
Pruritis drug reaction
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Low sensation / strength left leg
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Foot drop - left
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Ankle dorsiflexion
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Contralateral leg weakness
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Foot numbness bilateral
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Migraine
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Fibromyalgia
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Leg numbness
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Foot numbness
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Loss of consciousness
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Hit head
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Diabetic neuropathy
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Right leg weakness
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Left leg sensory
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Bilateral leg neuropathic pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Ipsilateral thigh pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Transient ischemic attack
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Confusion
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
L5 sensory
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Nervous system disorders
Contralateral leg numbness and pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Eye disorders
Cataracts
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Eye disorders
Corneal abrasion
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Endocrine disorders
Type 2 diabetes
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Endocrine disorders
Hypercholesterolemia
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Endocrine disorders
Osteopenia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Endocrine disorders
Diabetes mellitus
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Endocrine disorders
Hypercalcemia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Endocrine disorders
Osteoporosis
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Infections and infestations
Sinusitis
|
1.7%
3/172 • Number of events 4 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Infections and infestations
Wound seroma after pain pump removal
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Infections and infestations
Shingles
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Infections and infestations
Infection at flu shot site
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Infections and infestations
Cellulitis on leg
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Hypertension
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Edema on leg
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Tachycardia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Angina
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Cardiac disorders
Pericarditis
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Renal and urinary disorders
Kidney stone
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Renal and urinary disorders
UTI
|
2.9%
5/172 • Number of events 5 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Renal and urinary disorders
Urinary retention
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Renal and urinary disorders
Hematuria
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Renal and urinary disorders
Urge incontinence
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Dehydration
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Hiatal hernia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Acid reflux
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Gastrointestinal disorders
Bacterial gastroenteritis
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Nausea
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Intraoperative hemorrhage 800cc
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Surgery site pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Right foot weakness
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Wound infection / irritation
|
2.9%
5/172 • Number of events 5 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Revision - SIJ pain
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Injury, poisoning and procedural complications
Incision site numbness
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Blood and lymphatic system disorders
Transient WBC elevation
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Blood and lymphatic system disorders
Bilateral LE edema
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Blood and lymphatic system disorders
Chronic lymphocytic leukemia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Skin and subcutaneous tissue disorders
Allergic dermatitis to tape
|
0.58%
1/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Skin and subcutaneous tissue disorders
Finger laceration
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Skin and subcutaneous tissue disorders
Thumb laceration
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.1%
7/172 • Number of events 7 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.7%
3/172 • Number of events 3 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Psychiatric disorders
Anxiety
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Psychiatric disorders
Xanax withdrawal
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Psychiatric disorders
Drug addiction
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Vascular disorders
Abdominal aortic aneurysm
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Vascular disorders
Wound bleed post cervical fusion
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Numbness related to syringomyelia
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Ear and labyrinth disorders
Ear pain - eustachian tube problem
|
0.58%
1/172 • Number of events 1 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical myelopathy
|
1.2%
2/172 • Number of events 2 • 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
|
Additional Information
Daniel Cher, MD, Vice President of Clinical Affairs
SI-BONE, Inc.
Phone: 650-269-5763
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER