Extrait

Background and study aims Scoliosis is a progressive condition where the spine twists and curves in an abnormal way over time. Symptoms include a curved spine, prominent ribcage and one shoulder being higher than the other. It can cause back pain, particularly in adults, emotional problems (associated with body image and self-esteem) and, in some more severe cases, lung and heart problems as the ribcage can be pushed against these organs. In some cases, again particularly in adults, the bones in the spine can compress nerves which can lead to a number of problems including back and leg pain, numbness in the legs, incontinence and (in men) erectile dysfunction. One possible treatment is surgery, where the spine is moved to a more normal position using metal rods, plates and screws before finally being fused into place with bone grafts. This results in a completely stiff spine. A new system has been developed which corrects the spine which fusion, keeping it flexible. Since the spine is connected to the trunk (torso), this is corrected as well. To assess the new scoliosis correction device it is necessary to determine the individual stiffness of the patient’s trunk. To determine the stiffness of the trunk, a device named “Scolibed” has been developed. It is a bed-shaped mechanical system, divided into two parts, connected by an axis. It is unknown whether the device can measure the stiffness in a reproducible way and whether there is a large individual variation. From a scientific point of view it is interesting to know if the stiffness of a scoliotic spine is different from a healthy one, since it may provide information about the underlying mechanisms of scoliosis, which are not currently known. Here, we aim to the reproducibility of the device to observe and compare the variation in stiffness found among healthy subjects and scoliotic patients. The results of this work will be used as the basis for a bigger study assessing truncal stiffness in healthy subjects and patients. Who can participate? Healthy volunteers, between 12 and 14 years old and scoliotic patients, between 12 and 14 years old. What does the study involve? The participants are positioned on a vacuum mattress that is fixed to the “Scolibed” and strapped to the bed with Velcro® straps that are passed over the subject’s body (two straps over the upper part and three straps over the legs). Then the upper part is rotated relative to the lower part. The burden for the subjects is the tightness of the straps, and the unnatural feeling of being bent. The maximum time for a measurement session is limited to 60 minutes and will be done after a regular appointment with the orthopedic surgeon in case of patient subjects. Four measurement sessions have to be performed, three in the same day and one with a time difference of minimum 5 days and maximum 20 days. In this way, we hope to determine the repeatability of the “Scolibed” results, variation in stiffness for healthy individuals and variation in stiffness for scoliotic patients. We will also compare the results of healthy individuals and scoliotic patients. What are the possible benefits and risks of participating? The main risk of taking part in the study is that the participant is bent too much and experience pain. But since this being is done manually an immediate stop and movement back is possible. There is also a risk of device breaking or malfunctioning, causing the participant to fall on the ground. The design has been tested with volunteers and passed without any signs of failure. Finally, it is possible that the participants will receive an electric shock from the device. This risk is very low, however, since the patient is lying on a plastic vacuum mattress and a wooden bed frame and the sensors are running on low voltage. Where is the study run from? Department of Orthopaedic Surgery, Groningen University Medical Centre (Netherlands) When is the study starting and how long is it expected to run for? April 2015 to May 2015 Who is funding the study? Investigator initiated and funded Who is the main contact? Professor Bart Verkerke

Critère d'inclusion

• Scoliosis

Liens

• ictrp
• isrctn