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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01640353
First Posted: July 13, 2012
Last Update Posted: March 24, 2017
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.
Information provided by (Responsible Party):
SI-BONE, Inc.
  Purpose
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.

Condition
Degenerative Sacroiliitis Sacroiliac Joint Disruption

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

Further study details as provided by SI-BONE, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 194
Study Start Date: July 2012
Study Completion Date: February 2016
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with SI joint pain due to degeneration or disruption of the SI joint
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640353


  Show 26 Study Locations
Sponsors and Collaborators
SI-BONE, Inc.
Investigators
Principal Investigator: Bradley Duhon, MD University of Colorado, Denver
  More Information

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
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data is shared with YODA project.

Keywords provided by SI-BONE, Inc.:
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

Additional relevant MeSH terms:
Ankylosis
Sacroiliitis
Joint Diseases
Musculoskeletal Diseases
Arthritis