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Fusion Assessment Clinical Trial
Study Objective: The Fusion Assessment Clinical Trial (FACT) is an observational study designed to evaluate spinal fusion outcomes and investigate potential correlations between pretreatment conservative care and surgical outcomes. There is not an investigational device used in this study. The study simply monitors routinely scheduled spinal fusion procedures. Flexuspine's next study, the Posterior Arthroplasty Safety Study (PASS), will utilize the same inclusion and exclusion criteria as the FACT Study, thus allowing for a solid foundation for comparative analysis between the two patient groups. Participants: Spinal fusion candidates with Degenerative Disc Disease and facet compromise may enroll if they meet specific enrollment criteria. They will complete past medical history review, standard quality of life questionnaire, neurological exam, and x-rays. Study Overview: The spinal fusion procedure and instrumentation used is left up to the surgeon investigator's discretion. Patients are followed according to standard of care practices and are evaluated at hospital discharge; week 6; months 3, 6, 12, and 24. Follow-up visits involve quality of life questionnaires, neurological exam, and x-rays. Study data is recorded on case report forms, and the study will be monitored according to standards of Good Clinical Practice. Outcome measures analyzed: • Assessment of quality of life questionnaires, including Oswestry Disability Index |