Degenerative Sacroiliitis, Sacroiliac Joint Disruption
Conditions
Keywords
si joint, si joint pain, si joint injury, si joint treatment, si joint injections, si joint inflammation, si joint problems, si joint symptoms, hypermobile si joint, si joint arthritis, si joint pain treatment, inflamed si joint, si joint sclerosis, locked si joint, si joint injuries, si joint disease, si joint infection, sacroiliac joint pelvic pain, sacroiliac joint arthritis treatment
Brief summary
The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally invasive surgical procedure (one that uses a smaller incision and less damage to the skin and other tissues than standard surgery). The purpose of implanting the device is to stabilize and fuse the SI joint.
Interventions
None listed
Sponsors
SI-BONE, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1\. Age 21-70 at time of screening 2\. Patient has lower back pain for \>6 months inadequately responsive to conservative care 3\. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following: 1. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and 2. Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and 3. Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) (see Section 3.6.4), and 4. One or more of the following: i. SI joint disruption: 1. Asymmetric SI joint widening on X-ray or CT scan 2. Leakage of contrast on diagnostic arthrography ii. Degenerative sacroiliitis: 1. Radiographic evidence of SI joint degeneration, including sclerosis,osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or 2. Due to prior lumbosacral spine fusion 4\. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale 6. Patient has signed study-specific informed consent form 7. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
Exclusion criteria
1. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture 2. Other known sacroiliac pathology such as: 1. Sacral dysplasia 2. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy) 3. Tumor 4. Infection 5. Acute fracture 6. Crystal arthropathy 3. History of recent (\< 1 year) major trauma to pelvis 4. Previously diagnosed osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture). 5. Osteomalacia or other metabolic bone disease 6. Chronic rheumatologic condition (e.g., rheumatoid arthritis) 7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible 8. Chondropathy 9. Known allergy to titanium or titanium alloys 10. Use of medications known to have detrimental effects on bone quality and soft-tissue healing 11. Prominent neurologic condition that would interfere with physical therapy 12. Current local or systemic infection that raises the risk of surgery 13. Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation. 14. Currently pregnant or planning pregnancy in the next 2 years 15. Patient is a prisoner or a ward of the state. 16. Known or suspected drug or alcohol abuse 17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation 18. Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Success | Baseline and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Back Dysfunction | 24 months | 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%. |
| Change in Quality of Life | Baseline and 24 months | Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits |
| Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm) | 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. |
| Work Status | Basline, 24 months | Proportion of non-working subjects who return to work |
| Serious Adverse Events | Procedure, discharge, 1,3,6,12,18 and 24 months | 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. |
| Ambulatory Status | 24 months | Percentage of population fully ambulatory at 24 months post operatively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sacroiliac Joint Fusion SI Joint Fusion with iFuse implant system | 172 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Early site termination | 3 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 5 |
| Overall Study | Withdrawn from analysis at term site | 12 |
| Overall Study | Withdrew prior to treatment | 10 |
Baseline characteristics
| Characteristic | Sacroiliac Joint Fusion |
|---|---|
| Age, Continuous | 50.9 Years |
| Baseline EQ-5D | .43 units on a scale STANDARD_DEVIATION 0.18 |
| Baseline ODI | 55.2 units on a scale STANDARD_DEVIATION 11.5 |
| Baseline SF-36 PCS | 31.7 units on a scale STANDARD_DEVIATION 5.6 |
| Baseline SIJ pain | 79.8 units on a scale STANDARD_DEVIATION 12.8 |
| Duration of prior pain | 5.1 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 165 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 166 Participants |
| Region of Enrollment United States | 172 participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 52 Participants |
| SF-36 MCS | 38.5 units on a scale STANDARD_DEVIATION 11.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 153 / 172 |
| serious Total, serious adverse events | 67 / 172 |
Outcome results
Primary
Subject Success
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Sacroiliac Joint Fusion | Subject Success | 80.5 percentage of participants |
Secondary
Ambulatory Status
Percentage of population fully ambulatory at 24 months post operatively.
Time frame: 24 months
Population: 148 participants had ambulatory status at 24 month post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacroiliac Joint Fusion | Ambulatory Status | 89.2 percentage of participants |
Secondary
Change in Back Dysfunction
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
Population: 147 of participants had ODI at 24 months post-operatively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sacroiliac Joint Fusion | Change in Back Dysfunction | 24.5 units on a scale | Standard Deviation 21.1 |
Secondary
Change in Quality of Life
Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits
Time frame: Baseline and 24 months
Population: 148 participants had QOL information at 24 months post-operatively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sacroiliac Joint Fusion | Change in Quality of Life | SF36 PCS | 8.9 units on a scale | Standard Deviation 10.6 |
| Sacroiliac Joint Fusion | Change in Quality of Life | SF36 MCS | 10.1 units on a scale | Standard Deviation 11.8 |
| Sacroiliac Joint Fusion | Change in Quality of Life | EQ5D TTO | .27 units on a scale | Standard Deviation 0.26 |
Secondary
Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)
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
Population: 148 subjects had SIJ pain scores at 24 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sacroiliac Joint Fusion | Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm) | 53.3 units on a scale | Standard Deviation 27.6 |
Secondary
Serious Adverse Events
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
Population: 149 participants had 24 months of follow up post-operatively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacroiliac Joint Fusion | Serious Adverse Events | 100 serious adverse event |
Secondary
Work Status
Proportion of non-working subjects who return to work
Time frame: Basline, 24 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Sacroiliac Joint Fusion | Work Status | 25.0 percentage of participants |