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PASS (Posterior Arthroplasty Safety Study) Flexuspine has been granted conditional approval by the FDA (as of April, 2010) to begin the initial U.S. phase of the PASS Study. Patient enrollment will be underway shortly in the U.S., while Flexuspine continues to establish clinical study sites in several countries outside the U.S. for a similar study. Study Objective: Flexuspine’s Posterior Arthroplasty Safety Study is an early-stage interventional feasibility study that will provide Flexuspine the opportunity to evaluate safety and early efficacy parameters of the FSU under a controlled clinical setting. Patients who have been screened and found eligible for the study will undergo the FSU implant procedure. Study patient candidates are those most likely to otherwise receive a fusion procedure. See below for study inclusion and exclusion criteria. Participants: There are a limited number of sites and patients in the initial phase of the U.S. feasibility study. Sites outside the U.S. are currently being established. Study patients will be spinal fusion candidates with Degenerative Disc Disease and facet compromise. Enrolled patients will complete a past medical history review, standard quality of life questionnaire, neurological exam, and x-rays. Study Overview: 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: FACT (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. The FACT study is being conducted with similar inclusion and exclusion criteria as the PASS Study, thus allowing for a solid 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 in both studies: Summary of Patient Inclusion Criteria for both PASS and FACT Studies: General Exclusion Criteria for both PASS and FACT studies: For more information on Flexuspine’s clinical studies please contact:
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