Degenerative Sacroiliitis, Sacroiliac Joint Disruption
Conditions
Brief summary
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
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.
Interventions
RADIATIONPelvic CT Scan
Pelvic CT-Scan between 6-12 months post-op
Sponsors
Tenon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Fusion | 6-12 month post CATAMARAN Fixation Device implantation | The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Status | 6-12 months post-op | Radiographic assessment for device status: device placement, loosening, migration and/or breakage |
| Surgical re-intervention for SI joint pain | 6-12 months post-op | Proportion of patients requiring surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain |
| Neurologic worsening related to the sacral spine | 6-12 months post-op | Proportion of patients experiencing neurologic worsening related to the sacral spine compared to baseline |
| Serious device related adverse events | 6-12 months post-op | Summary of all serious device related adverse events |
Countries
United States
Outcome results
None listed