Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.
ClinicalTrials.gov Identifier:
NCT01640353
First received: July 6, 2012
Last updated: July 31, 2014
Last verified: July 2014
  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 Phase
Degenerative Sacroiliitis
Sacroiliac Joint Disruption
Phase 4

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: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Improvement in SI joint pain [ Time Frame: Screening,1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Improvement in ODI at post-operative visits

  • Improvement in quality of life [ Time Frame: Baseline, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time to full ambulation amongst those without full ambulation at baseline

  • Work status [ Time Frame: Baseline,1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
    Proportion of non-working subjects who return to work

  • Serious adverse events [ Time Frame: Procedure, discharge, 1,3,6,12,18 and 24 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 250
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640353

  Show 27 Study Locations
Sponsors and Collaborators
SI-BONE, Inc.
  More Information

No publications provided

Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT01640353     History of Changes
Other Study ID Numbers: 300101
Study First Received: July 6, 2012
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014