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The objective of this study is to gather clinical data on SI-LOKĀ® for the treatment of sacroiliac joint dysfunction.
The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOKĀ® for treatment of sacroiliac joint dysfunction with a minimum of three screws.
Clinical Research Forms will be completed at all pre-op, intra-op and post-op visits by either the surgeon, clinical coordinator or patient.
Forms completed by patients will be checked, initialed and dated by the site coordinator.
Data collected will be presented as mean +/- standard deviation. Statistical significance will be evaluated at the P < 0.05 significance level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SI-Joint Dysfunction | Device- SI-LOK |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SI-LOK | Device | Sacro-iliac joint fusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Evaluation | Fusion Assessment Radiolucency | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization Data | Operative Time Blood Loss Blood Transfusion Hospitalization Time | Intra-Operative |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Patient Self-Assessments | Back and Leg Pain Measured by Visual Analog Scale Oswestry Disability Index (ODI) Patient Satisfaction | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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Patients will be screened according to inclusion/exclusion criteria and will be selected for the treatment using the SI-LOKĀ® system
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| Name | Affiliation | Role |
|---|---|---|
| Michael Barnum, MD | Northwestern Medical Center, St Albans, VT 05478 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medical Center | Saint Albans | Vermont | 05478 | United States |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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