Joint Dysfunction
Conditions
Keywords
Sacro-iliac Joint
Brief summary
The objective of this study is to gather clinical data on SI-LOK® 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-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.
Detailed description
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.
Interventions
DEVICESI-LOK
Sacro-iliac joint fusion
Sponsors
Globus Medical Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* A maximum age of 70 years * Diagnosis of SIJ dysfunction * Ability to provide Informed Consent for study participation and to return for all follow-up visits
Exclusion criteria
* Previous documentation of osteopenia or osteomalacia * History of metabolic bone disease (e.g. diabetes requiring daily insulin) * Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing * Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.) * History of substance abuse (drugs or alcohol) * Condition that would preclude completing patient self assessment questionnaires * Mentally incompetent or prisoner * Currently a participant in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Evaluation | 2 years | Fusion Assessment Radiolucency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization Data | Intra-Operative | Operative Time Blood Loss Blood Transfusion Hospitalization Time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Composite of Patient Self-Assessments | 2 years | Back and Leg Pain Measured by Visual Analog Scale Oswestry Disability Index (ODI) Patient Satisfaction |
Countries
United States
Outcome results
None listed