Participant Information Form
Study Title: Patient reported outcomes of arthroscopic meniscal repair with fibrin clot augmentation.
Principal Investigator: Dr P. Myers
Associate Investigators: Dr M. Goldberg, Dr J. Gill, Dr T. McMeniman
Site: Brisbane Orthopaedic and Sports Medicine Centre, Brisbane Private Hospital
You are being invited to participate in a research study. Before you decide whether to participate, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information and feel free to ask us if you would like more information or if there is anything that you do not understand. We would like to stress that you do not have to accept this invitation and should only agree to take part if you want to.
Thank you for reading this.
What is the purpose of this research?
Tears of the meniscus are a common cause of knee pain and mechanical symptoms, such as locking and giving way. Meniscal tears can be treated surgically by either trimming the torn meniscus (known as debridement) or by repairing the torn meniscus. Your surgeon has selected for you to have a meniscal repair procedure based on your age, level of activity and the pattern of your meniscal tear.
Fibrin clot (blood clot) can be added to a meniscal repair procedure in order to promote meniscal healing. To date, there have been no large studies published about the results of meniscal repair with fibrin clot augmentation. We are hoping that with your participation, we could publish the world’s largest study looking at the results of meniscal repair with fibrin clot augmentation and help to quantify how successful this technique is for treating meniscal tears.
Why have I been invited to take part?
Our medical records indicate that you have undergone a meniscal repair with fibrin clot augmentation with either Dr Peter Myers or Dr Tim McMeniman since January 2016 at the Brisbane Private Hospital. We would like to assess how well your knee is progressing since your surgery. In particular, we would like to look at your knee pain, activity levels, knee-related quality of life and satisfaction with surgery.
What does my participation in this research involve?
It involves completing a brief online survey about how your knee. It should take no more than 10 minutes to complete. Your answers to these questions will help us to assess the outcomes of this technique.
Do I have to take part in this research project?
No. Your participation is completely voluntary If you choose not to participate, it will in no way affect your relationship with your surgeon or clinical care. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage without penalty to your medical care.
Will my information be kept confidential?
Yes. Your information and answers to your questions will be kept confidential. Only the study team will be able to access this information. Any personal details published in the study will be completely de-identified.
Will I be paid for my participation?
No. There will be no financial payment for participating in this study. However, your participation in this study will help to contribute to the medical profession’s knowledge and understanding of this procedure.
Will I be able to access the results of the study?
Yes. We will publish the de-identified summary of results from this study on our website for you to access and view (www.bosmc.com.au/research).
What are the risks and disadvantages of taking part?
There are no risks or disadvantages of taking part. In fact, your participation in this study will help to contribute to the medical profession’s knowledge and understanding of the procedure.
Further information and who to contact
The person you may need to contact will depend on the nature of your query.
Clinical contact person
If you want any further information concerning this project, you can contact the principal study doctor on (07) 3834 6683 the following people:
Name: Dr Peter Myers
Position: Orthopaedic Surgeon and Research Director
Telephone: (07) 3834 6683
Email: p.myers@bosmc.com.au
Complaints contact person
For matters relating to research at the site at which you are participating, the details of the local site complaints person are:
Name: Dr Jessica Bartlett
Position: BOSMC Research Manager
Telephone: (07) 3834 6635
Email: research@bosmc.com.au