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SILVIA
Primary Endpoints:
Radiographic
Proportion of subjects with S2AI screw loosening or other adverse findings on 2-year CT scans (see protocol for details)
Clinical
Proportion of subjects who develop new onset SIJ pain
Change in SIJ pain in subjects with SIJ pain preoperatively (see protocol for details)
Secondary Endpoints:
Clinical
Proportion of subjects requiring revision of S2AI screws
Proportion of subjects who require therapeutic injection or other non-medicine-based intervention to treat SIJ pain
(For further details, see protocol)
Radiographic
Incidence of S2AI screw breakage
Incidence of S2AI screw loosening
Incidence of abnormal bone reaction in the pelvis
Change in sagittal alignment parameters (see protocol for details)
Primary Endpoints:
Radiographic
Proportion of subjects with S2AI screw loosening or other adverse findings on 2-year CT scans (see protocol for details)
Clinical
Proportion of subjects who develop new onset SIJ pain
Change in SIJ pain in subjects with SIJ pain preoperatively (see protocol for details)
Secondary Endpoints:
Clinical
Proportion of subjects requiring revision of S2AI screws
Proportion of subjects who require therapeutic injection or other non-medicine-based intervention to treat SIJ pain
(For further details, see protocol)
Radiographic
Incidence of S2AI screw breakage
Incidence of S2AI screw loosening
Incidence of abnormal bone reaction in the pelvis
Change in sagittal alignment parameters (see protocol for details)
Recruitment Status
Past Studies