The efficacy of surgical decompression before 24 hours versus 24 to 72 hours in patients with spinal cord injury from T1 to L1 – with specific consideration on ethics: a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>There is no clear evidence that early decompression following spinal cord injury (SCI) improves neurologic outcome. Such information must be obtained from randomized controlled trials (RCTs). To date no large scale RCT has been performed evaluating the timing of surgical decompression in the setting of thoracolumbar spinal cord injury. A concern for many is the ethical dilemma that a delay in surgery may adversely effect neurologic recovery although this has never been conclusively proven. The purpose of this study is to compare the efficacy of early (before 24 hours) verse late (24–72 hours) surgical decompression in terms of neurological improvement in the setting of traumatic thoracolumbar spinal cord injury in a randomized format by independent, trained and blinded examiners.</p> <p>Methods</p> <p>In this prospective, randomized clinical trial, 328 selected spinal cord injury patients with traumatic thoracolumbar spinal cord injury are to be randomly assigned to: 1) early surgery (before 24 hours); or 2) late surgery (24–72 hours). A rapid response team and set up is prepared to assist the early treatment for the early decompressive group. Supportive care, i.e. pressure support, immobilization, will be provided on admission to the late decompression group. Patients will be followed for at least 12 months posttrauma.</p> <p>Discussion</p> <p>This study will hopefully assist in contributing to the question of the efficacy of the timing of surgery in traumatic thoracolumbar SCI.</p> <p>Trial Registration</p> <p><b>RCT registration number: ISRCTN61263382</b></p

Biomechanical Comparison of Transpedicular Versus Extrapedicular Vertebroplasty Using Polymethylmethacrylate

Study Design: An in vitro biomechanical study using osteoporotic cadaveric vertebrae. Objective: To compare the biomechanics of transpedicular and extrapedicular approaches in polymethylmethacrylate vertebroplasty in terms of height restoration, strength, and stiffness. Summary Background Data: Cement is typically injected through a transpedicular approach in both vertebroplasty and kyphoplasty procedures. Previous biomechanical studies were primarily focused on the transpedicular approach. Extrapedicular approach has been recently developed to provide more symmetric cement filling and has good clinical results. However, no biomechanical data are available to compare these 2 techniques. Methods: Twenty-four osteoporotic vertebral bodies were randomly divided into 2 groups for either transpedicular or extrapedicular vertebroplasty. Six lumbar and 6 thoracic vertebrae were used for each group. Each vertebral body was compressed by 25% of its original height and its strength and stiffness were measured. The vertebral bodies were treated with polymethylmethacrylate using either transpedicular or extrapedicular approach. The height restoration was measured before the treated vertebrae were recompressed to determine posttreatment strength and stiffness. Results: Both techniques increased vertebral strength by approximately 50% of the intact strength. There was no statistical difference in posttreatment strength between these 2 techniques. However, the transpedicular technique had higher stiffness recovery (70% to 80%) from the intact stiffness than the extrapedicular technique (60%). The extrapedicular approach achieved greater height restoration in thoracic vertebrae. Conclusions: Both extrapedicular and transpedicular techniques increased strength but reduced stiffness compared with the intact condition. The extrapedicular technique achieved greater height restoration possibly attributed to its easier access to the fracture site. These biomechanical data provide useful information when selecting an approach for cement injection in vertebroplasty procedures