Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

Sacroiliac Joint Disruption Clinical Trial

— SIFI  

Official title:

Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01640353
• Other study ID #: 300101
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 6, 2012
• Last updated: May 8, 2015
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: SI-BONE, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Sacroiliitis
• Sacroiliac Joint Disruption
• Sacroiliitis

Locations

Country	Name	City	State
United States	Overlake Hospital Medical Center	Bellevue	Washington
United States	Silicon Valley Spine	Campbell	California
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Brazos Spine	College Station	Texas
United States	Columbia Orthopaedic Group	Columbia	Missouri
United States	Orthopaedic Clinic of Daytona Beach	Daytona Beach	Florida
United States	The Orthopaedic Institute/NFRMC	Gainsville	Florida
United States	Spine and Neuro Center	Huntsville	Alabama
United States	East Tennesse Brain & Spine Center	Johnson City	Tennessee
United States	Midwest Division-RMC, LLC,-Research Medical Center	Kansas City	Missouri
United States	Bartow Regional Medical Center	Lakeland	Florida
United States	Alice Peck Day Memorial Hospital	Lebanon	New Hampshire
United States	Bluegrass Orthopaedics & Hand Care Research	Lexington	Kentucky
United States	Piedmont Orhopaedics	Macon	Georgia
United States	Orthopaedic Center of Southern Illinois	Mt. Vernon	Illinois
United States	Manhattan Orthopedic Spine, PLLC	New York	New York
United States	BASIC Spine	Newport Beach	California
United States	Orthopedic and Reconstructive Center (formally)Health Research Institute	Oklahoma City	Oklahoma
United States	Neurosurgical and Spine Specialists	Parker	Colorado
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Texas Back Institute	Plano	Texas
United States	Southern California Center for Neuroscience and Spine (SCCNS)	Pomona	California
United States	Virginia Spine Institute	Reston	Virginia
United States	St. Mary's Spine	San Francisco	California
United States	Mercy Medical Research Institute	Springfield	Missouri
United States	Precision Spine Care	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
SI-BONE, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months	Yes
Secondary	Improvement in SI joint pain	Improvement in SI joint pain VAS score at post-operative visits	Screening,1, 3, 6, 12, 18 and 24 months	No
Secondary	Improvement in back dysfunction	Improvement in ODI at post-operative visits	Screening,1, 3, 6, 12 and 24 months	No
Secondary	Improvement in quality of life	Improvement in QOL as measured by SF-36 PCS and EQ-5D at post-operative visits	Baseline, 6, 12 and 24 months	No
Secondary	Ambulatory status	Time to full ambulation amongst those without full ambulation at baseline	Baseline,1,3, 6, 12, 18 and 24 months	No
Secondary	Work status	Proportion of non-working subjects who return to work	Baseline,1, 3, 6, 12, 18 and 24 months	No
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.	Procedure, discharge, 1,3,6,12,18 and 24 months	Yes