Innovative Spinopelvic Solutions with Real-World Evidence

• Conditions: Sacroiliac Joint Dysfunction; Sacroiliac Joint Pain

• Registration Number: NCT06706908
• Lead Sponsor: SI-BONE, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-27
• Status Verified: 2024-12
• Study Start: 2024-12-15
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2034-12
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change in patient reported outcomes	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.

Trial Locations

Locations (1)

SI-BONE; 🇺🇸 Santa Clara, California, United States