Extrait

Background and study aims Spinal fusion surgery (spondylodesis) is a type of surgical procedure which joins two or more vertebrae (small bones that make up the spine) together. It is more often used to treat a condition called spondylolisthesis, where one of the vertebrae slips out of position onto the vertebra below it. There are different approaches to this type of surgery however it is not known which is most effective. The most commonly used method involves fusing the spine with something called a pedicle screw, which anchors the vertebrae together. Although it is an established technique, it is still a very invasive procedure with high complication rates. Therefore, minimally invasive approaches were developed, the medialized bilateral pedicle screw fixation (mPACT) being one of them. The aim of this study is to compare the safety and efficiency of these two procedures. Who can participate? Adults with spondylolisthesis who require spinal fixation surgery. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group undergo surgery using the pedicle screw technique and those in the second group undergo surgery using the mPACT technique. Participants in both groups complete a number of assessments and questionnaires at the start of the study, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery, in order to find out how successful the surgery was. What are the possible benefits and risks of participating? This study does not intervene in the therapeutic decision process of the patients and in the surgical procedure. All participants will receive the same standardized postoperative treatment regime already established in the our center. No additional treatments are required for this study. Postoperative evaluation for study purposes will not differ between the study groups. Patients might benefit from a more frequent and standardized postoperative monitoring and documentation. Since these two techniques are well-established and this study does not intervene in the therapeutic decision process and in the surgical procedure, there is no additional risk for the patient when participating in this study. Where is the study run from? The study is run from International Centre for Diarrhoeal Disease Research, Bangladesh and takes place in villages in Khishoreganj district (Bangladesh) When is the study starting and how long is it expected to run for? July 2016 to August 2018 Who is funding the study? Medical University of Innsbruck (Austria) Who is the main contact? Dr Anja Tschugg [email protected]

Critère d'inclusion

• Spondylodesis

Liens

• isrctn