OrthoFundamentals, LLC
The purpose of this study is to determine the clinical efficacy of The Trellis SI Joint Fusion System in unilateral sacroiliac (SI) joint fusion surgeries.
This multi-center, post-market, prospective clinical study evaluates patients identified by the Investigator in their practice. The purpose of this study is to determine the clinical efficacy of The Trellis SI Joint Fusion System in unilateral sacroiliac (SI) joint fusion surgeries.
Inclusion Criteria: 1. Age ≥ 21 at time of screening; 2. Diagnosis of unilateral sacroiliac (SI) joint dysfunction (degenerative sacroiliitis or sacroiliac disruption) 3. Presence of low back/buttock pain and unresponsive to non-operative treatment for at least 6 months or has the presence of progressive symptoms in the face of conservative treatment; Oswestry Disability Index (ODI) score ≥ 30%; 4. SIJ pain score ≥ 5 on 0-10 numerical rating scale (NRS); 5. Ability and willingness to comply with follow-up regimen; and 6. Written informed consent by the patient Exclusion Criteria: 1. Low bac…
TRELLIS SI Joint Fusion System
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