Clinical trial NCT02270203: LOIS: Long-Term Follow-Up in INSITE/SIFI
Official title: LOIS: Long-Term Follow-Up in INSITE/SIFI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Sacroilitis
Sacroiliac Joint Disruption
Keywords: si joint
si joint injury
si joint treatment
si joint inflammation
si joint problems
si joint symptoms
hypermobile 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
si joint pain
si joint injections
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 103
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement.

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Subject Success
timeFrame: 3 years on LOIS (5 years post-op)
measure: Radiographic (CT) apposition of bone to sacral and iliac sides of implant
timeFrame: 3 years on LOIS (5 years post-op)
Secondary outcomes:
measure: VAS (Visual Analog Scale)
timeFrame: 3 years on LOIS (5 years post-op)
measure: Oswestry Disability Index (ODI) Questionnaire
timeFrame: 3 years on LOIS (5 years post-op)
measure: Improvement in quality of life (QOL)
timeFrame: 3 years on LOIS (5 years post-op)
measure: non-working subjects returning to work
timeFrame: 3 years on LOIS (5 years post-op)
measure: CT scans showing bridging bone
timeFrame: 3 years on LOIS (5 years post-op)
measure: SAE (Serious Adverse Events) occurrence rate
timeFrame: 3 years on LOIS
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Stockbridge
country: United States
facility: Regenerative Orthopaedics and Spine Institute
state: Georgia
city: Mount Vernon
country: United States
facility: Orthopaedic Center of Southern Illinois
state: Illinois
city: Lexington
country: United States
facility: Bluegrass Orthopaedics & Hand Care
state: Kentucky
city: Columbia
country: United States
facility: Columbia Orthopaedic Group
state: Missouri
city: Oklahoma City
country: United States
facility: Oklahoma Center for Spine & Pain Solutions
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allegheny Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Green Bay
country: United States
facility: Aurora Research Institute
state: Wisconsin
city: Wauwatosa
country: United States
facility: Integrated Spine Care
state: Wisconsin
Study officials:
affiliation: SI-BONE, Inc.
name: Daniel Cher, MD
role: STUDY_DIRECTOR
References:
citation: Darr E, Cher D. Four-year outcomes after minimally invasive transiliac sacroiliac joint fusion with triangular titanium implants. Med Devices (Auckl). 2018 Aug 29;11:287-289. doi: 10.2147/MDER.S179003. eCollection 2018.