SI Joint Stabilization in Long Fusion to the Pelvis (SILVIA)
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- STATUS
- Recruiting
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- End date
- Dec 13, 2024
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- participants needed
- 220
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- sponsor
- SI-BONE, Inc.
Summary
The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.
Description
This is a multicenter randomized controlled, postmarket clinical study to determine the differences between subjects undergoing standard MLF surgery with S2AI fixation in the pelvis vs the additional placement of iFuse 3-D in the bedrock configuration during MLF surgery. Subjects will be monitored for sacroiliac (SI) joint pain and at two years post surgery a CT scan will be taken to assess S2AI screw loosening or any other findings.
Details
| Condition | Sacroiliac Joint Disruption, Scoliosis Lumbar Region |
|---|---|
| Treatment | iFuse 3-D in Bedrock Configuration, Multilevel Lumbar Fusion surgery |
| Clinical Study Identifier | NCT04062630 |
| Sponsor | SI-BONE, Inc. |
| Last Modified on | 13 May 2022 |
Eligibility
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