Study on the outcome of surgical and conservative treatment of odontoid fractures in patients over 55 Years Old
Dear Sir/Madam,
We would like to invite you to take part in our research study. Before you decide we would like you to understand why the research is being done and what it would involve for you.
One of our team will go through the information sheet with you and answer any questions you have. Ask us if there is anything that is not clear. It is important that you understand why this research is being conducted and what it includes. It is up to you to decide to join the study. We will describe the study and go through this information sheet. If you agree to take part, we will then ask you to sign a consent form. You are free to withdraw at any time, without giving a reason. This would not affect the standard of care you receive. Please discuss this decision with family/friends if you would like to.
Introduction
You have recently developed a cervical spine fracture. The protrusion on top of your second cervical vertebra (the ‘odontoid’ process) has broken. This fracture can be treated in two ways: either by means of an operation or in a conservative manner (in which case you will receive a cervical collar or a so-called halo-vest). Both these methods have been used for a long time, but it is not yet clear which of these two gives the best results in older patients. In the case of surgical treatment, complications such as infections, bleeding, thrombosis, or complications from the anaesthetic can arise. Conservative treatment poses the risk of the fracture not healing well, which makes later surgery necessary in some cases. The research that we are inviting you to take part in compares the results of the two different treatments. Each doctor will carry out the treatment he or she finds most suitable in your case. Both before and after the start of treatment you will be asked to share your experiences with us by filling in questionnaires.
What is the purpose and design of the study?
The purpose of this study is to gain insight into whether surgical or conservative management is superior for management of odontoid peg fractures. We hope to do this by comparing the outcome and other data from all participating patients. Along with information on the type of treatment that is carried out, data on the type of fracture, physical condition (e.g. degree of osteoporosis) your symptoms and how well you function will be considered. We will ask you about mobility, independence in daily like, pain perception, emotional experiences and use of pain killers/medication. Coordination of this study is being carried out from the Leiden University Medical Centre in the Netherlands. Many European hospitals will be taking part.
What can you expect if you take part in the study?
Your doctor will determine the kind of treatment that will be carried out (this will be the usual treatment and the decision is not effected by the research). Before the start of the treatment, you will be asked to complete a couple of questionnaires. The questions are about your quality of life, pain perception, and other complaints as a result of the odontoid fracture. Completing these lists will take no more than 10 minutes. You will need to visit the clinic five times for a follow-up visit. For this study we ask you, to complete a questionnaire. We will send you this questionnaire before each appointment. You can fill out this questionnaire at home and take them to the clinic after completion. Two years after the start of the study, the last follow-up appointment is scheduled, after which your part in the study ends. We cannot promise the study will help you, but the information we get from this study will help improve the treatment of people with odontoid peg fracture.
Confidentiality of your data
The information we collect from you during this study will be anonymously stored in a database. We will collect the information from the questionnaires that you fill in and any scans that you have during your treatment. Access to the database is possible with a password only. The data will be stored for 15 years after completion of the study. It is possible that the data will also be used for future research. On the consent form you can specify whether or not you agree to this.
Who has reviewed the study?
The study has been reviewed by: The NRES Committees - North of Scotland.
Who will have access to the data?
The data will be provided to the SIPS Group who are coordinating this study. The SIPS Group is based at the University of Leiden in the Netherlands. They will treat the data confidentially.
Where can you obtain more information?
If you have any questions, concerns or complaints during the study please contact your treating doctor/researcher:
Mr Jake Timothy
Department of Neurosurgery
Leeds General Infirmary
Great George Street
West Yorkshire
LS1 3EX
0113 3922283
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March 15, 2014. Version 2