This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
Study Type
OBSERVATIONAL
Enrollment
120
Satisfaction survey will be administered to collect real world evidence on patients that previously received the TransLoc 3D System commercially.
Advanced Orthopedic Center
Port Charlotte, Florida, United States
RECRUITINGPatient Satisfaction Survey
Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint
Time frame: Prospective 12 to 18 months post surgery
Visual Analogue Scale (VAS) of pain
Retrospective analysis of VAS pre and post surgery, if available
Time frame: Baseline up to 1 year post surgery
Oswestry Disability Index (ODI)
Retrospective analysis of ODI pre and post surgery, if available
Time frame: Baseline up to 1 year post surgery
SAEs
Retrospective capture of Serious Adverse Events (SAEs) from the time of SI Fusion up to 90 days post operatively that required re-operation or in-patient hospitalization.
Time frame: Time of surgery up to 90 days post surgery
CT Scan Second Read (Radiological Overread)
CT scan for placement and fusion
Time frame: 12 to 18 months post fusion surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.