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INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative incidence of: |
| At the following timepoints, 1-, 3-, 6-, and 12-months. |
Inclusion Criteria:
Exclusion Criteria:
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Patients treated with an implant manufactured by SI-BONE.
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| Name | Affiliation | Role |
|---|---|---|
| Robyn Capobianco, PhD | SI-BONE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SI-BONE | Santa Clara | California | 94087 | United States |
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