Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Multi-Center, Single Arm Post-Market Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System.

Conditions
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Sacroiliac Joint Disruption, Degenerative Sacroiliitis

Intervention / Treatment
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* Radiation: Pelvic CT Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient >18 years of age at time of treatment with the CATAMARAN SI Joint Fusion System Patient implanted with the CATAMARAN Fixation Device within the last 12 months Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis Patient, or authorized representative, signs a written Informed Consent form to participate in the study Patient is willing and able to complete study follow-up requirements Exclusion Criteria: Known or suspected active drug or alcohol abuse Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis. Prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture) Prior diagnosis of tumor in sacrum or ilium Unstable fracture of sacrum and or ilium involving the targeted SIJ Osteomalacia or other metabolic bone disease Use of medications known to have detrimental effects on bone quality and soft-tissue healing Patient is pregnant or wishes to become pregnant during the study period Patient is not likely to comply with the follow-up evaluation schedule Patient is a prisoner or a ward of the state

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CATAMARAN SI Joint Fusion System<br>Subjects previously treated with the CATAMARAN Fixation Device | Radiation: Pelvic CT Scan<br>* Pelvic CT-Scan between 6-12 months post-op<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Fusion | The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist. | 6-12 month post CATAMARAN Fixation Device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Status | Radiographic assessment for device status: device placement, loosening, migration and/or breakage | 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 | 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 | 6-12 months post-op | 
| Serious device related adverse events | Summary of all serious device related adverse events | 6-12 months post-op |