Participant Information Form
Study Title: Incidence of new meniscal and chondral injuries between first and second stage revision ACL reconstruction
Principal Investigator: Dr T. McMeniman
Associate Investigators: Dr M. Goldberg, Dr A. O’Neill, Dr B. Collins, Dr P. Myers
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?
Graft re-rupture is a relatively common complication of ACL reconstruction surgery, which often necessitates a revision ACL reconstruction. Revision ACL reconstruction can be performed in either a single or two-stage procedure. A two-stage procedure is usually reserved for patients who have wide, or inappropriately positioned bone tunnels (through which the graft is passed).
In a two-stage revision, the first stage involves debridement (clearing out) and bone-grafting of the existing femoral and tibial tunnels, leaving the ACL unreconstructed. The second stage involves revision of the ligament reconstruction and is usually performed at least six months after the first stage, in order to allow incorporation of the bone graft.
One disadvantage of a two-stage revision ACL reconstruction is that the patient remains ACL-deficient for a longer period of time than if they had had a single stage revision procedure. Studies demonstrate that ACL deficiency for a prolonged period increases the risk of meniscal and chondral injury. Studies suggest that these can lead to poorer outcomes from ACL reconstruction and increase the risk of long term arthritis.
Up until now, there have been very few studies looking at the incidence of new meniscal and cartilage injuries between first and second stage revision ACL reconstruction, and none performed in an Australian patient population. This study aims to quantify the risk of developing a new meniscal or cartilage injury between first and second stage revision ACL reconstruction in an Australian patient population. We are also aiming to see whether these new injuries relate to an increased level of physical activity during the six-month period between the two surgical procedures.
The results of this study will help us to more accurately advise patients about the risks of two stage revision ACL reconstruction surgery. It will also help us to counsel patients about the importance of limiting physical activity levels between the first and second stage procedures.
Why have I been invited to take part?
You have been identified as having had a two-stage revision ACL reconstruction done by Dr Tim McMeniman, Dr Peter Myers, Dr Anthony O’Neill or Dr Brett Collins in the past. We would like to determine whether you had any new meniscal or cartilage injuries sustained in the time between your first and second stage revision procedures. We would also like to find out how much physical activity / exercise you were doing between your two revision ACL revision procedures. We are aiming to determine whether those who engaged in more physical activity were more likely to sustain a new meniscal or cartilage injury.
What does my participation in this research involve?
We would ask that you please complete a short survey about your levels of physical activity between your first and second stage revision ACL procedures. It should take no more than 5 minutes to complete. Your answers to these questions will help us to determine whether increased physical activity correlates with an increased incidence of meniscal or cartilage injury.
Do I have to take part in this research project?
No. Completion of the survey is optional. If you choose not to participate, it will in no way affect your future treatment at this practice. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.
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 revision ACL reconstruction.
Will I be able to access the results of the study?
Yes. We eventually intend to publish the results of this study in a peer-reviewed scientific journal, which will be accessible to you.
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) 3839 5095 the following people:
Name: Dr Tim McMeniman
Position: Orthopaedic Surgeon and Research Director
Telephone: (07) 3839 5095
Email: tmoffice@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