Health questionnaires: Participants are expected to complete a series of health questionnaires (i.e. numerical rating scale, Oswestry Disability Index) relevant to their treatment using a SI-BONE implant.
Study summary
INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age \> 21 at time of screening.
2. Patient will undergo a procedure utilizing an iFuse Implant family product.
3. Patient is comfortable communicating in written and spoken English.
4. Patient is willing and able to complete study questionnaires online, using either a smartphone, tablet, or computer.
5. Patient is willing and able to provide informed consent to participate
Exclusion Criteria:
1. Patient has fibromyalgia.
2. Patient has a pain pump.
3. Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
Primary outcome measure(s)
Change in patient reported outcomes — From enrollment and at the following timepoints, 1-, 3-, 6-, and 12-months. Change in pain as rated on a numerical rating scale (NRS), 0 being no pain and 10 being the worst pain imaginable at baseline and follow-up timepoints.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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