Innovative Spinopelvic Solutions With Real-World Evidence

NCT06706908 | Active Not Recruiting

• 1 other identifier: 302022
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sacroiliac Joint Dysfunction; Sacroiliac Joint Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in patient reported outcomes

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

Other Outcomes (1)

• Postoperative incidence of:

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

Interventions

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with an implant manufactured by SI-BONE.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SI-BONE, Inc.: lead

Study Sites (1)

SI-BONE

Santa Clara, California, 94087, United States

Location

Study Officials

• Robyn Capobianco, PhD

  SI-BONE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 27, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)