View clinical trials related to Vertebral Compression Fractures.
Filter by:The VITTA trial is a randomized, controlled, single-blinded, cross-over trial comparing percutaneous vertebroplasty with facet block in patients with acute (<1month) and painful vertebral compression fractures. The treatment offered for vertebral compression fractures (VCFs) in the interventional arm of the trial is vertebroplasty, which will be performed in accordance with the standardized protocol of the Canadian Association of Radiologists. Patients in the control arm will receive facet block, where a long-acting local anesthetic agent and corticosteroids are injected in the spinal articular facets at the affected level.
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA) bone cement. The purpose of the study is to provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the US. This investigational device is intended to restore biomechanical integrity to a vertebral body that has suffered a painful compression fracture in the thoracic or lumbar spine between levels T6 and L5.
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.