Northwestern Medical Center
Saint Albans, Vermont, 05478, United States
NCT Number: NCT01861899
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.
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Notify Me21 year–70 year
All sexes
Observational
Saint Albans, Vermont, 05478, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sacro-iliac joint fusion
Time frame: 2 years
Fusion Assessment Radiolucency
Time frame: Intra-Operative
Operative Time Blood Loss Blood Transfusion Hospitalization Time
Time frame: 2 years
Back and Leg Pain Measured by Visual Analog Scale Oswestry Disability Index (ODI) Patient Satisfaction
Globus Medical Inc
Industry
Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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