Sacroiliac Joint Dysfunction, Sacroiliac Joint Pain
Conditions
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.
Interventions
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.
Sponsors
SI-BONE, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative incidence of: | 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) |
Countries
United States
Outcome results
None listed