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Trial record 2 of 5 for:    si-bone

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by SI-BONE, Inc.
Sponsor:
Information provided by (Responsible Party):
SI-BONE, Inc.
ClinicalTrials.gov Identifier:
NCT02270203
First received: October 16, 2014
Last updated: August 23, 2016
Last verified: August 2016
  Purpose

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 Intervention
Degenerative Sacroilitis
Sacroiliac Joint Disruption
Radiation: Pelvic CT at 5 years post-op

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: LOIS: Long-Term Follow-Up in INSITE/SIFI

Further study details as provided by SI-BONE, Inc.:

Primary Outcome Measures:
  • VAS (Visual Analog Scale) [ Time Frame: 3 years on LOIS (5 years post-op) ] [ Designated as safety issue: No ]
    improvement in VAS (Visual Analog Scale), Sacroiliac (SI) joint joint pain by ≥20 mm

  • Absence of device-related SAE (Serious Adverse Events) [ Time Frame: 3 years on LOIS (5 years post-op) ] [ Designated as safety issue: Yes ]
    Absence of device-related SAE (Serious Adverse Events)

  • Absence of neurological worsening [ Time Frame: 3 years on LOIS (5 years post-op) ] [ Designated as safety issue: Yes ]
    Absence of neurological worsening.

  • Absence of surgical re-intervention on the target SI joint [ Time Frame: 3 years on LOIS (5 years post-op) ] [ Designated as safety issue: Yes ]
    Absence of surgical re-intervention on the target SI joint(s)


Secondary Outcome Measures:
  • VAS (Visual Analog Scale) [ Time Frame: 3 years on LOIS ] [ Designated as safety issue: No ]
    Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits.

  • Oswestry Disability Index (ODI) Questionnaire [ Time Frame: 3 years on LOIS ] [ Designated as safety issue: No ]
    Improvement in Oswestry Disability Index (ODI) at follow-up visits.

  • Improvement in quality of life (QOL) [ Time Frame: 3 years on LOIS ] [ Designated as safety issue: No ]
    Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits.

  • non-working subjects returning to work [ Time Frame: 3 years on LOIS ] [ Designated as safety issue: No ]
    Proportion of non-working subjects who return to work

  • CT scans showing bridging bone [ Time Frame: 3 years on LOIS (5 years post-op) ] [ Designated as safety issue: No ]
    Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively

  • SAE (Serious Adverse Events) occurrence rate [ Time Frame: 3 years on LOIS ] [ Designated as safety issue: Yes ]
    Occurrence rate of serious adverse events.


Other Outcome Measures:
  • Patient Satisfaction [ Time Frame: 3 years on LOIS ] [ Designated as safety issue: No ]
    Patient Satisfaction Questionnaire. At clinic follow up visits, the subject will complete a brief questionnaire rating satisfaction with iFuse result and whether the subject would undergo iFuse treatment again.

  • Zung Self-Rating Depression Scale (SDS) [ Time Frame: 3 years on LOIS ] [ Designated as safety issue: No ]
    At clinic follow-up visits subjects will complete a brief questionnaire developed to characterize a patient's level of depression. It is a 20-item multiple-response questionnaire that assesses depressive symptoms.Analysis of depression scores and medications for depression.

  • Denver SI Joint Questionnaire (DSIJQ) [ Time Frame: 3 years on LOIS ] [ Designated as safety issue: No ]
    At clinic follow-up visits subjects will complete a brief questionnaire developed to address sacroiliac joint (SI joint) related dysfunction. Analysis of the Denver SI Joint Questionnaire data as a specific measure of SI joint related disability.


Estimated Enrollment: 225
Study Start Date: October 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Pelvic CT at 5 years post-op
    Pelvic CT at 5 years post-op
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02270203

Contacts
Contact: Kathryn Wine, MPH 408-207-0700 ext 2215 kwine@si-bone.com
Contact: Daniel Cher, MD 408-207-0700 ext 2233 dcher@si-bone.com

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Bethany Samperi    203-737-8356    bethany.samperi@yale.edu   
Principal Investigator: Peter Whang, MD         
United States, Georgia
Regenerative Orthopaedics and Spine Institute Recruiting
Stockbridge, Georgia, United States, 30281
Contact: Terry Price    404-234-8716    terrellprice@gmail.com   
Principal Investigator: Philip Ploska, MD         
United States, Illinois
Orthopaedic Center of Southern Illinois Recruiting
Mt. Vernon,, Illinois, United States, 62864
Contact: Cristy Buchanan    618-242-3778 ext 7176    cristyb@OCOSI.ORG   
Principal Investigator: Don A Kovalsky, MD         
United States, Kentucky
Bluegrass Orthopaedics & Hand Care Recruiting
Lexington, Kentucky, United States, 40509
Contact: Elaine Wilhite    859-422-4552    eschuwilhite@gmail.com   
Principal Investigator: Harry Lockstadt, MD         
United States, Missouri
Columbia Orthopaedic Group Recruiting
Columbia, Missouri, United States, 65201
Contact: Michelle Vogt    573-443-2402 ext 4391    m.vogt@columbiaorthogroup.com   
Principal Investigator: S. Craig Meyer, MD         
United States, Oklahoma
Orthopedic and Reconstructive Center Recruiting
Oklahoma City, Oklahoma, United States, 73109
Contact: Julie White    405-702-4440    jwhite@medicalresearchintl.com   
Contact: Kallena Haynes    405-702-4440    Khaynes@medicalresearchintl.com   
Principal Investigator: Cheng-Lun Soo, MD         
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Matt Yeager    412-359-4272    myeager@wpahs.org   
Principal Investigator: Michael Oh, MD         
United States, South Carolina
MUSC Recruiting
Charleston, South Carolina, United States, 29425
Contact: Monica Baczko, MPA    843-792-8169    baczko@musc.edu   
Principal Investigator: Emily Darr, MD         
Sub-Investigator: John Glaser, MD         
United States, Texas
Precision Spine Care Active, not recruiting
Tyler, Texas, United States, 75701
United States, Washington
Overlake Hospital Medical Center Active, not recruiting
Bellevue, Washington, United States, 98004
United States, Wisconsin
Midwest Orthopedic Specialty Hospital Recruiting
Franklin, Wisconsin, United States, 53132
Contact: Tracy Mente, BSN    414-259-7327    Tracy.Mente@wfhc.org   
Principal Investigator: Clay J Frank, MD         
Aurora Research Institute Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Taylor Romdenne    920-288-3127    taylor.romdenne@aurorabaycare.com   
Principal Investigator: Robert Limoni, MD         
Sponsors and Collaborators
SI-BONE, Inc.
  More Information

Responsible Party: SI-BONE, Inc.
ClinicalTrials.gov Identifier: NCT02270203     History of Changes
Other Study ID Numbers: 300244 
Study First Received: October 16, 2014
Last Updated: August 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by SI-BONE, Inc.:
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

ClinicalTrials.gov processed this record on December 07, 2016