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

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ClinicalTrials.gov Identifier: NCT02270203
Recruitment Status : Active, not recruiting
First Posted : October 21, 2014
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.

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

Condition or disease Intervention/treatment
Degenerative Sacroilitis Sacroiliac Joint Disruption Radiation: Pelvic CT at 5 years post-op

Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LOIS: Long-Term Follow-Up in INSITE/SIFI
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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


Primary Outcome Measures :
  1. Subject Success [ Time Frame: 3 years on LOIS (5 years post-op) ]
    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).

  2. Radiographic (CT) apposition of bone to sacral and iliac sides of implant [ Time Frame: 3 years on LOIS (5 years post-op) ]
    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.


Secondary Outcome Measures :
  1. VAS (Visual Analog Scale) [ Time Frame: 3 years on LOIS (5 years post-op) ]
    Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits.

  2. Oswestry Disability Index (ODI) Questionnaire [ Time Frame: 3 years on LOIS (5 years post-op) ]
    Improvement in Oswestry Disability Index (ODI) at follow-up visits.

  3. Improvement in quality of life (QOL) [ Time Frame: 3 years on LOIS (5 years post-op) ]
    Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits.

  4. non-working subjects returning to work [ Time Frame: 3 years on LOIS (5 years post-op) ]
    Proportion of non-working subjects who return to work

  5. CT scans showing bridging bone [ Time Frame: 3 years on LOIS (5 years post-op) ]
    Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively

  6. SAE (Serious Adverse Events) occurrence rate [ Time Frame: 3 years on LOIS ]
    Occurrence rate of serious adverse events.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270203


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Georgia
Regenerative Orthopaedics and Spine Institute
Stockbridge, Georgia, United States, 30281
United States, Illinois
Orthopaedic Center of Southern Illinois
Mount Vernon, Illinois, United States, 62864
United States, Kentucky
Bluegrass Orthopaedics & Hand Care
Lexington, Kentucky, United States, 40509
United States, Missouri
Columbia Orthopaedic Group
Columbia, Missouri, United States, 65201
United States, Oklahoma
Orthopedic and Reconstructive Center
Oklahoma City, Oklahoma, United States, 73159
United States, Pennsylvania
Jason Sumner
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
MUSC
Charleston, South Carolina, United States, 29425
United States, Texas
Precision Spine Care
Tyler, Texas, United States, 75701
United States, Washington
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
United States, Wisconsin
Aurora Research Institute
Green Bay, Wisconsin, United States, 54311
Integrated Spine Care
Wauwatosa, Wisconsin, United States, 53132
Sponsors and Collaborators
SI-BONE, Inc.
Investigators
Study Director: Daniel Cher, MD SI-BONE, Inc.

Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT02270203     History of Changes
Other Study ID Numbers: 300244
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by SI-BONE, Inc.:
si joint
si joint injury
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si joint inflammation
si joint problems
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si joint arthritis
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si joint sclerosis
locked si joint
si joint injuries
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sacroiliac joint pelvic pain
sacroiliac joint arthritis treatment
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