ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.

July 6, 2012
July 13, 2012
July 11, 2016
March 24, 2017
March 24, 2017
July 2012
January 2015   (Final data collection date for primary outcome measure)
Subject Success [ Time Frame: 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.
Subject Success [ Time Frame: 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.
Complete list of historical versions of study NCT01640353 on ClinicalTrials.gov Archive Site
  • Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm) [ Time Frame: 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.
  • Change in Back Dysfunction [ Time Frame: 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 [ Time Frame: Baseline and 24 months ]
    Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits
  • Ambulatory Status [ Time Frame: 24 months ]
    Percentage of population fully ambulatory at 24 months post operatively.
  • Work Status [ Time Frame: Basline, 24 months ]
    Proportion of non-working subjects who return to work
  • Serious Adverse Events [ Time Frame: 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.
  • Improvement in SI joint pain [ Time Frame: Screening,1, 3, 6, 12, 18 and 24 months ]
    Improvement in SI joint pain VAS score at post-operative visits
  • Improvement in back dysfunction [ Time Frame: Screening,1, 3, 6, 12 and 24 months ]
    Improvement in ODI at post-operative visits
  • Improvement in quality of life [ Time Frame: Baseline, 6, 12 and 24 months ]
    Improvement in QOL as measured by SF-36 PCS and EQ-5D at post-operative visits
  • Ambulatory Status [ Time Frame: Baseline,1,3, 6, 12, 18 and 24 months ]
    Time to full ambulation amongst those without full ambulation at baseline
  • Work Status [ Time Frame: Baseline,1, 3, 6, 12, 18 and 24 months ]
    Proportion of non-working subjects who return to work
  • Serious Adverse Events [ Time Frame: 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.
Not Provided
Not Provided
 
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Subjects with SI joint pain due to degeneration or disruption of the SI joint
  • Degenerative Sacroiliitis
  • Sacroiliac Joint Disruption
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
250
February 2016
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01640353
300101
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Data is shared with YODA project.
SI-BONE, Inc.
SI-BONE, Inc.
Not Provided
Principal Investigator: Bradley Duhon, MD University of Colorado, Denver
SI-BONE, Inc.
February 2017