View clinical trials related to Spinal Disease.
Filter by:This study is designed as a post-marketing observational, controlled, prospective, non-inferiority study where the efficacy and safety of the Degenerative Disc Disease treatment by arthrodesis using PEEK(PolyEtherEtherKetone)-Titanium polyaxial interspinous posterior fusion device ROMEO®2 PAD will be compared to the gold standard treatment by instrumented circumferential arthrodesis. The primary study aim is to evaluate functional improvement at 1 and 2 years after surgery. The fusion at 1 year and 2 years post-surgery, the short and long- term clinical and neurological success and patient related health status satisfaction will also be evaluated.
This study aims to improve understanding of the relationship between spinal alignment and walking and balance in people who have degenerative spinal conditions.
This is a prospective, exploratory study to verify intra-operative handling and safety and to collect preliminary short-term safety and efficacy data of the Turris® Facet Fuser, a small bioresorbable device for the immediate immobilization of the facet joint. Patients eligible for study enrollment will present with degenerative lumbar spinal diseases involving the L4/L5 segment and requiring spinal fusion.
The objective of this pilot study is to determine if degenerative spinal disorders such as acute radiculopathy, myelopathy, stenosis, or disc and facet disease cause detectable alterations in Substance P levels in saliva, serum and cerebrospinal fluid. If this pilot study shows a correlation between Substance P levels and pain associated with degenerative spinal disorders, then a larger study will be initiated to determine the feasibility of using Substance P levels in the diagnosis and treatment of degenerative spinal disease.
Phase 1 - Optimization Phase: Primary Objective: The primary objective of Phase 1 of this study is to determine the time point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard vertebroplasty and Kyphoplasty procedures relative to baseline CTCB. Phase 2 - Comparison Phase: Primary Objective: The primary objective of Phase 2 of this study is to determine the change in CTCB from baseline to post-treatment as measured using the CellSearch™ Assay and to compare the average change between treatment groups with and without the use of the Cavity SpineWand. Secondary Objectives: - To determine the change in self-reported pain level from baseline to post-treatment as measured using the visual analogue scale (VAS) for spine pain and to compare the average change in pain level between treatment groups. - To determine the change in pain status from baseline to post-treatment as measured using the Brief Pain Inventory (BPI) and to compare the average change in pain status between treatment groups. - To determine the change from baseline to post-treatment in the M.D. Anderson Cancer Center Symptom Inventory (MDASI) and to compare the average change between treatment groups. - To determine the change from baseline to post-treatment in time to walk a 50-foot distance and to compare the average change between treatment groups.