Frequently Asked Questions
I am an interested surgeon, but I do not have a research staff. Can I participate in this study?
Yes. This is an observational, real-conditions-of-use study. While the study follows ICH and GCP guidelines, this is not an FDA-mandated study; therefore it is not as demanding on your resources. You do not need a designated study coordinator on staff in order to participate. Contact SPIRITT to learn how you can be a part of this study: coflexCOMMUNITY@spirittresearch.com
As a patient, how do I know if I am eligible to participate?
Surgeons participating in the coflex®COMMUNITY study will determine the eligibility of their coflex patients based on the study protocol, and will offer eligible patients the opportunity to participate.
Will my personal information be protected?
Both your doctor and SPIRITT have taken precautions to protect the data collected for this study. These precautions include, for example, developing and using unique user ids and passwords to access the database, not sharing that information with other people, special security clearance to protect your email address in the database, and using an electronic data storage system that is designed to ensure the security of protected health information according to federal HIPAA regulations.
Will I be compensated for my participation in the study?
You maintain responsibility for your healthcare costs whether you participate in the study or not. There will be no cost to you to participate in the study. Compensation will be provided to you at each postoperative study interval for completing the surveys, as listed below.
You will be paid for completing the surveys on the following schedule after your surgery:
6 weeks: $25
3 months: $25
6 months: $25
12 months: $25
24 months: $25
36 months: $25
48 months: $50
60 months: $75
Who do I contact if I have questions about the study?
Please email coflexCOMMUNITY@spirittresearch.com or call 314-738-8026