Active — Not RecruitingNot Applicable

Innovative Spinopelvic Solutions With Real-World Evidence

United States1,000 participantsStarted 2024-12-15

Plain-language summary

INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Age \> 21 at time of screening.
✓. Patient will undergo a procedure utilizing an iFuse Implant family product.
✓. Patient is comfortable communicating in written and spoken English.
✓. Patient is willing and able to complete study questionnaires online, using either a smartphone, tablet, or computer.
✓. Patient is willing and able to provide informed consent to participate

Exclusion criteria

✕. Patient has fibromyalgia.
✕. Patient has a pain pump.
✕. Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation

What they're measuring

Change in patient reported outcomes

Timeframe: From enrollment and at the following timepoints, 1-, 3-, 6-, and 12-months.

Trial details

NCT IDNCT06706908

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2034-12

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