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OpenTrials
Active, Not Recruiting

NCT Number: NCT06706908

Innovative Spinopelvic Solutions With Real-World Evidence

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sacroiliac Joint Dysfunction Sacroiliac Joint Pain

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SI-BONE

Santa Clara, California, 94087, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health questionnaires

Other

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.

Primary outcomes

  1. Change in patient reported outcomes

    Time frame: 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.

Secondary outcomes

  1. Change in patient reported outcomes

    Time frame: At the following timepoints: 1-, 3-, 6-, and 12-months.

    Change in patient satisfaction on a four point scale, with 0 being very dissatisfied and 3 being very satisfied at follow-up timepoints.

Other outcomes

  1. Postoperative incidence of:

    Time frame: At the following timepoints, 1-, 3-, 6-, and 12-months.

    • Serious adverse events probably or definitely related to the implant of interest
    • Implant failures related to the implant of interest (e.g., revision surgery)

Sponsors and collaborators

Lead sponsor

SI-BONE, Inc.

Industry

Registry information

Acronym: INSPIRE

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Nov 27, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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