Innovative Spinopelvic Solutions with Real-World Evidence

N/AEnrolling By InvitationNCT06706908

SI-BONE, Inc.1,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Sacroiliac Joint Dysfunction Sacroiliac Joint Pain

Interventions

Health questionnairesOTHER

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

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

SI-BONE

Santa Clara, California, United States

Outcomes

Primary Outcomes

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.

Time frame: From enrollment and at the following timepoints, 1-, 3-, 6-, and 12-months.

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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