LOIS: Long-Term Follow-Up in INSITE/SIFI

Sacroiliac Joint Disruption Clinical Trial

— LOIS  

Official title:

LOIS: Long-Term Follow-Up in INSITE/SIFI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270203
• Other study ID #: 300244
• Status: Completed
• Start date: October 2014
• Est. completion date: July 2019

Study information

• Verified date: August 2019
• Source: SI-BONE, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).

Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are:

• SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and

• INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patient enrolled and treated in SIFI or patient initially randomized to iFuse and treated in INSITE. Note: Patient may be in the initial follow up period associated with SIFI or INSITE at the same time they consent for this study and "extend" their post-operative follow up.

2. Patient has signed study-specific LOIS informed consent form.

3. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.

Exclusion Criteria:

1. Treated with iFuse as a "crossover" in INSITE.

2. Currently pregnant or planning pregnancy within 5 years of iFuse Implant.

3. Patient is a prisoner or a ward of the state.

4. Known or suspected active drug or alcohol abuse.

5. Inadequately treated psychiatric illness (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.

6. Unwilling to perform the long-term follow up requirements of this study.

7. Patient has any condition that could substantially prevent long-term follow-up.

8. Unwilling to return to site at pre-specified study visits.

Related Conditions & MeSH terms

• Degenerative Sacroilitis
• Sacroiliac Joint Disruption

Intervention

Radiation:
• Pelvic CT at 5 years post-op
Pelvic CT at 5 years post-op

Locations

Country	Name	City	State
United States	Overlake Hospital Medical Center	Bellevue	Washington
United States	MUSC	Charleston	South Carolina
United States	Columbia Orthopaedic Group	Columbia	Missouri
United States	Aurora Research Institute	Green Bay	Wisconsin
United States	Bluegrass Orthopaedics & Hand Care	Lexington	Kentucky
United States	Orthopaedic Center of Southern Illinois	Mount Vernon	Illinois
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Oklahoma Center for Spine & Pain Solutions	Oklahoma City	Oklahoma
United States	Allegheny Medical Center	Pittsburgh	Pennsylvania
United States	Regenerative Orthopaedics and Spine Institute	Stockbridge	Georgia
United States	Precision Spine Care	Tyler	Texas
United States	Integrated Spine Care	Wauwatosa	Wisconsin

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 success defined as improvement in VAS (Visual Analog Scale) recorded at SIFI or INSITE Baseline VAS back pain score by =20 mm; Absence of device-related SAE (Serious Adverse Events) ; Absence of neurological worsening related to the sacral spine,& Absence of surgical re-intervention on the target SI joint(s).	3 years on LOIS (5 years post-op)
Primary	Radiographic (CT) apposition of bone to sacral and iliac sides of implant	Proportion of subjects (with CT) who had at least 30% apposition of bone to sacral and iliac sides in at least 2 of 3 iFuse implants.	3 years on LOIS (5 years post-op)
Secondary	VAS (Visual Analog Scale)	Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits.	3 years on LOIS (5 years post-op)
Secondary	Oswestry Disability Index (ODI) Questionnaire	Improvement in Oswestry Disability Index (ODI) at follow-up visits.	3 years on LOIS (5 years post-op)
Secondary	Improvement in quality of life (QOL)	Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits.	3 years on LOIS (5 years post-op)
Secondary	non-working subjects returning to work	Proportion of non-working subjects who return to work	3 years on LOIS (5 years post-op)
Secondary	CT scans showing bridging bone	Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively	3 years on LOIS (5 years post-op)
Secondary	SAE (Serious Adverse Events) occurrence rate	Occurrence rate of serious adverse events.	3 years on LOIS