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

Status: Completed
Location: See all (12) locations...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

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

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

Locations
United States
Connecticut
Yale University School of Medicine
New Haven
Georgia
Regenerative Orthopaedics and Spine Institute
Stockbridge
Illinois
Orthopaedic Center of Southern Illinois
Mount Vernon
Kentucky
Bluegrass Orthopaedics & Hand Care
Lexington
Missouri
Columbia Orthopaedic Group
Columbia
Oklahoma
Oklahoma Center for Spine & Pain Solutions
Oklahoma City
Pennsylvania
Allegheny Medical Center
Pittsburgh
South Carolina
MUSC
Charleston
Texas
Precision Spine Care
Tyler
Washington
Overlake Hospital Medical Center
Bellevue
Wisconsin
Aurora Research Institute
Green Bay
Integrated Spine Care
Wauwatosa
Time Frame
Start Date: 2014-10
Completion Date: 2019-07
Participants
Target number of participants: 103
Related Therapeutic Areas
Sponsors
Leads: SI-BONE, Inc.

This content was sourced from clinicaltrials.gov