The objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the CATAMARAN SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated.
Patients with degenerative sacroiliitis or sacroiliac joint disruption who already had the CATAMARAN Fixation Device implanted between 6 and 12 months will be asked to return for follow-up visit to evaluate clinical outcomes and undergo a high resolution pelvic CT-Scan to assess fusion. Additionally, retrospective clinical outcomes will be collected from the medical records.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
Pelvic CT-Scan between 6-12 months post-op
Minimally Invasive Neurosurgery of Texas
Plano, Texas, United States
St. George Orthopaedic Spine
St. George, Utah, United States
Radiographic Fusion
The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist.
Time frame: 6-12 month post CATAMARAN Fixation Device implantation
Device Status
Radiographic assessment for device status: device placement, loosening, migration and/or breakage
Time frame: 6-12 months post-op
Surgical re-intervention for SI joint pain
Proportion of patients requiring surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain
Time frame: 6-12 months post-op
Neurologic worsening related to the sacral spine
Proportion of patients experiencing neurologic worsening related to the sacral spine compared to baseline
Time frame: 6-12 months post-op
Serious device related adverse events
Summary of all serious device related adverse events
Time frame: 6-12 months post-op
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