Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy...
Vertebral Body Compression Fractures (VCFs)The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.
A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures
Vertebral Compression FracturesOsteoporotic Vertebral Compression Fractures1 moreThe objective of this study is to gather data regarding the efficacy, safety and cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures less than 6 weeks old. The AVAMAX vertebroplasty kits (Care Fusion) will be used for all vertebroplasties. The primary effectiveness analysis will be based on the number of patients whose numeric rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly larger proportion of patients achieving pain reduction than the control group. A secondary analysis will compare the change in mean pain scores and specific activity related pain scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary effectiveness analysis will include the mean change in the back-pain specific limitation in function as quantified by the Roland Scale at these same data collection time points.
Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial
Osteoporotic Vertebral Compression FracturesRandomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.
To Evaluate Success of Cement Treatment of Spinal Compression Fractures
Back PainPatients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Vertebral Compression FractureBalloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.
The PRIORi-T Trial--Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation...
Painful Osteoporotic Vertebral Compression Fractures (VCF)The objective of this post market clinical investigation is to evaluate the clinical effectiveness of a minimally invasive vertebral augmentation procedure, Radiofrequency-Targeted Vertebral Augmentation (RF-TVA) as compared to non-operative management (NOM) for the treatment of appropriately diagnosed acute (≤ 8 weeks) painful osteoporotic vertebral compression fractures (VCF).
Evaluation of Vertebral Compression Fracture Fixation With RF Kyphoplasty in Patients With Multiple...
Multiple MyelomaCompression Fracture of Vertebral ColumnThe objective of this post market clinical study is to collect prospective clinical data to confirm the efficacy of RF Kyphoplasty for the treatment of pathological fractures of the spine caused by multiple myeloma.
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures...
Multiple MyelomaThe purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life.
Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures
Vertebral Body Compression FracturesThe primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.
Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural...
Vertebral CompressionVertebra Compression Fracture1 moreThe goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.