• INSPIRE: Innovative Spinopelvic solutions with Real-world Evidence

  • About this study

    This study aims to collect health outcomes following a procedure using SI-BONE implants.

    Expectations and Requirements

    • You are scheduled for a procedure using an implant manufactured by SI-BONE.
    • You are over the age of 21.
    • You’ll be asked to provide contact information to receive email correspondence.
    • You’ll be asked to complete occasional short surveys related to your pain, health status, and disability before and after treatment.

  • Steps to Enroll

  • You will read some materials and answer a few questions to verify your understanding and eligibility for this study. If you qualify, you can then sign the informed consent form. 

    This should take about 10 minutes. 

  • Informed Consent

  • What is the purpose of this Consent?

    The informed consent describes in detail how the study works and your role in it. Your signature means that you understand and agree to participate in the study.

    You are receiving this Informed Consent Form (Consent) because you are undergoing a procedure using an implant manufactured by SI-BONE. SI-BONE is interested in understanding how your procedure is benefiting you.

    The purpose of this consent form is to provide you with information on: 

    1. what will happen in this study and your responsibilities, 
    2. information that will be collected, 
    3. potential risks associated with your participation,  
    4. how to withdraw from the study, and 
    5. how your data will be used.

    Your decision to participate in this study is completely voluntary. You may decide not to participate, or you may leave the study at any time.  Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled. If you decide to take part in the study, you will receive a signed copy of this Consent.

    Please read this information carefully before you sign it. Ask questions about anything that you don’t understand or want to know more about.

  • Title Innovative Spinopelvic Solutions with Real-World Evidence (INSPIRE)
    Protocol No.:

    303022
    WCG IRB Protocol #20244458
    Sponsor: SI-BONE
    Investigator:

    Robyn Capobianco, PhD
    471 El Camino Real
    Suite 101
    Santa Clara, California 95050
    United States
    Study-related Phone Number:  408-677-2014 (24 hours)

     

  • RESEARCH CONSENT SUMMARY

    You are being asked for your consent to take part in a research study. This document provides a concise summary of this research. It describes the key information that we believe most people need to decide whether to take part in this research. Later sections of this document will provide all relevant details.

    Your participation in this study is voluntary. You may decide not to participate or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled.

    If you have questions, concerns, or complaints, or think this research has hurt you, talk to the research team at the phone number(s) listed in this document.

    How long will I be in this research?

    We expect that your taking part in this research will last for at least 12 months following your procedure, or until the study ends. Your participation may end early if you wish to leave the study, or the study is terminated.

    Why is this research being done?

    The purpose of this research is to collect information on how your pain, health status, and disability improve following treatment.

    What happens to me if I agree to take part in this research?

    If you decide to take part in this research study, the general procedures include completing short surveys about your health status, medical history, pain, disability, and quality of life before and after treatment for your SI joint issues. These surveys will be sent to your email and can be completed on a smartphone, tablet, or computer. No physical exams or office visits are required for the study.

    Could being in this research hurt me?

    The most important risks or discomforts that you may expect from taking part in this research include mental fatigue from completing the questionnaires and emotional discomfort when asked about your medical history. Although all study data that identifies you will be protected and treated as confidential, total confidentiality cannot be guaranteed. There could be unauthorized access to, or security breaches of the systems used to store your study data. There may be other privacy risks that we have not foreseen.

    Will being in this research benefit me?

    The most important benefits that you may expect from taking part in this research include helping doctors gain more information on how to best treat people with conditions like yours and increasing diversity and representation in SI joint research.

    What other choices do I have besides taking part in this research?

    Instead of being in this research, your choices may include not participating in this study.

    There is a possibility that identifiers might be removed from your private information and then used or distributed for future research studies without your additional informed consent.

  • DETAILED RESEARCH INFORMATION

  • Study Purpose

    You are invited to participate in a health outcomes study focused on individuals who have undergone a procedure using an implant manufactured by SI-BONE.

    This study will collect information on how your pain, health status, and disability improve following treatment. The procedure and the implants are not experimental. The implants are cleared by the FDA.

    A description of this clinical trial is available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. This website does not contain individual participant information.

  • What will happen if I take part in the study?

  • How many people will participate in this study?

    The study will enroll up to 1000 people who undergo a procedure using an implant manufactured by SI-BONE.

    How long will my participation in this study take?

    We ask that you agree to participate for at least 12 months following your procedure, or until the study ends. Your participation may end early if you wish to leave the study, or the study is terminated.

    What are the study procedures and where will it take place?

    You will complete short surveys about your health status, medical history, pain, disability, and quality of life before and after treatment for your SI joint issues. These surveys will be sent to your email and can be completed on a smartphone, tablet, or computer. No physical exams or office visits are required for the study.

    Baseline Survey

    Within 1-2 days after you sign this consent, you will receive a link from INSPIRE@si-bone.com to complete a few short surveys that help study staff understand your health status before your procedure. This should take about 10 minutes to complete.

    Follow up Surveys

    Shortly following your procedure and at periodic intervals (i.e., 1, 3, 6 and 12 months) you will receive an email link to complete follow-up health surveys. These surveys will collect your current health status related to your treatment. This should take about 10 minutes to complete. When surveys have been verified as complete, you will receive a $20 electronic Amazon gift card to compensate you for your time.

    Once you have completed the 12-month surveys, your participation in the study is complete. You may be asked to continue participation at this timepoint.

    Are there benefits to participating in this study?

    No. You will not directly benefit from participation in this study. The study will give doctors more information on how to best treat people with conditions like yours. Your participation will help increase diversity and representation in SI joint research.

    Are there any alternatives to participating? 

    This study is for research purposes only. The only alternative is to not participate in this study.

  • Study Data

  • What type of data is collected?

    As part of the study, certain information will be collected from you. This is called “Study Data” and will be used for the purpose described in this consent.

    Data collected for this study include:

    • Your contact information, including your name, email address, and phone number.
    • Information about you, such as your age, gender, height, weight, ethnicity, and race.
    • Brief medical history, including any chronic conditions.
    • Information about your surgical procedure, including the number and type of implants used. This information may be collected from your doctor.
    • Your satisfaction with the results of your procedure.
    • Your average pain rating on a 0-10 scale, where 0=no pain and 10= worst pain.
    • Oswestry Disability Index (ODI) – a questionnaire on disability related you back pain and quality of life.

    If you report having any problems related to your procedure, the study staff may reach out to you to ask more questions. They may also talk to your treating physician and ask for test results to better understand the problem you may be having.

    If you do not want to share this data with study staff, you should not participate in this study.

  • Health information 

    Study staff may need to communicate with your doctor if you have a problem related to your surgery. They may ask for additional information, including test reports and imaging studies that have been performed. These will not be shared with anyone outside of the research team.


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  • How will my study data be kept confidential?  

    Your participation in this study is private and will remain confidential, unless the law requires us to share it.

    Records that identify you as a participant will be kept confidential by trained study staff. Access will be limited to only those who need access in order to conduct the study.

    Your contact information and other directly identifying information (example, date of birth) will be kept secure and separate from the rest of your study data. Your record will be replaced with a random identifier that is unique to you but is not based on any information about you. Your data will not be directly linked to you. This data is called “deidentified” because it is not directly linked to you.

    Who will have access to my study data? 

    Your deidentified study data may be review or used by: 

    • regulatory authorities and government agencies - US Food and Drug Administration or European regulatory bodies.
    • WCG Institutional Review Board (IRB) – An IRB is an independent group of people (scientists and non-scientists) who review the ethics of research.  
    • representatives of the sponsor. 

    How may my study data be used? 
    By signing the consent form, you consent to the investigator and study staff to collect, use, store, analyze, disclose, and otherwise process your study data for the following purposes: 

    • To support and carry out the study.  
    • To contact you about the study. 
    • To analyze study data and publish study results. 
    • To verify that the study is done properly. 
    • To design or improve future studies and or products manufactured by SI-BONE. 
    • To combine the results of this study with other studies. 

    Any information obtained for the purpose of this study that can identify you will be treated as confidential and securely stored.  It will be disclosed only with your permission, or as required by law. 
     
    Results of this study may be published but your identity will not be disclosed. 

    How long will my study data be retained? 

    Your study data will be retained for as long as needed for the purposes of the study. 

  • Risks, Inconveniences, and Financial Considerations

  • What risks or inconveniences should I expect from participating?

    There is no potential risk for physical harm if you participate in this study.

    You may experience mental fatigue from completing the questionnaires. The system allows you to take breaks, as needed, while completing the surveys. You may experience emotional discomfort, for example, when asked about your medical history. You can withdraw from the study at any time.

    Although all study data that identifies you will be protected and treated as confidential, total confidentiality cannot be guaranteed. There could be unauthorized access to, or security breaches of the systems used to store your study data. There may be other privacy risks that we have not foreseen.

    As with all studies, there may be risks that are not known at this time.

    What happens if there are new information during the study?

    Any new information that is discovered during this study, which may influence your willingness to continue participating will be sent to you by email. You may be asked to sign a new consent form if this occurs.

    Will it cost anything for me to participate?

    There is no cost to you to participate in this study. You must have access to the internet to participate in the study. Standard phone usage rates may apply if you communicate with researchers by phone.

    Will I be paid for participating?

    Upon completion of each follow-up survey (starting at 1-month), you will receive a $20 Amazon electronic gift card to compensate you for your time.

    Is there an opportunity for commercial gain by participating?

    The sponsor has no plans to offer you financial compensation or share any profits from the commercialization of any products, technologies, or processes developed from this study. You will not lose any legal rights to which you are entitled by signing this consent.

  • Withdrawing from the study

  • Your participation in this study may be stopped at any time with or without your consent for any of the following reasons:

    • if you fail to follow directions for participating in the study.
    • it is discovered that you do not meet the study requirements.
    • if the study staff finds that it is not in your best interest to continue taking part in the study.
    • if the study is cancelled.

    You can stop participating in the study at any time, without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care.

    This is done by notifying the study staff via email. If you leave the study before the planned final follow-up, data collected up to the time you withdraw will remain part of the research project results.

  • Study Contact Information

    The person you may need to contact will depend on the nature of your question.

  • Sponsor Information

    This study is initiated and sponsored by SI-BONE, Inc, the manufacturer of the implant. “Study staff” includes employees of SI-BONE who are working on this study, including the principal investigator listed at the beginning of this Consent.

    Study-related questions

    If you have any questions about the study at any time, you can visit the Frequently asked questions (FAQs) available on the study website. If you want any further information concerning this project not covered on the FAQs, please send an email to INSPIRE@si-bone.com.

    For technical assistance relating to study surveys

    Please send an email to INSPIRE@si-bone.com

    Medical Emergencies

    For medical emergencies, please call 911.

    Research Ethics 

    This research is being overseen by WCG IRB. An IRB is a group of people who perform independent reviews of research studies. If you have any question, concerns, or complaints that are not being answered by the research team about any aspect of the trial, the way it is being conducted, your rights as a research subject, or any questions about being a research participant in general, then you may contact:

    WCG IRB, tel: (855) 818-2289 or clientcare@wcgclinical.com.

  • Authorization for Release of Health Information

  • I have been given the information about the use and disclosure of my health information for this research study.  My questions have been answered.  
      
    I authorize the use and disclosure of my health information to the parties listed in the authorization section of this consent for the purposes described above.  

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  • Thank you for your interest in our study. We regret to inform you that you do not meet the eligibility criteria. We appreciate your time and understanding.

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