Innovative Spinopelvic Solutions With Real-World Evidence (INSPIRE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sacroiliac Joint Pain; Sacroiliac Joint Dysfunction
• Intervention / Treatment: Other: Health questionnaires

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Clara, California, United States, 94087
      • SI-BONE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with an implant manufactured by SI-BONE.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient reported outcomes	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.	From enrollment and at the following timepoints, 1-, 3-, 6-, and 12-months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient reported outcomes	Change in patient satisfaction on a four point scale, with 0 being very dissatisfied and 3 being very satisfied at follow-up timepoints.	At the following timepoints: 1-, 3-, 6-, and 12-months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative incidence of:	Serious adverse events probably or definitely related to the implant of interest; Implant failures related to the implant of interest (e.g., revision surgery)	At the following timepoints, 1-, 3-, 6-, and 12-months.

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.
• Investigators: Principal Investigator: Robyn Capobianco, PhD, SI-BONE

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia
• Other Study ID Numbers: 302022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No