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Active, not recruiting Observational

Innovative Spinopelvic Solutions With Real-World Evidence

NCT06706908 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2024-12-15
Last updated
2026-04-24

Condition(s) studied

Sacroiliac Joint DysfunctionSacroiliac Joint Pain

Investigational drug(s) / intervention(s)

Health questionnaires

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.

Trial sites (1)

FacilityCityRegionStatus
SI-BONE Santa Clara California
Official registry record

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.

View NCT06706908 on ClinicalTrials.gov ↗ ← All trials in the USA