Information for the public
We hope these answers address any questions you might have about deciding to take part in the STRAP ACL study.
The anterior cruciate ligament (ACL) is a strong band of tissue inside your knee that helps keep it stable. Sometimes, the ACL can tear. Doctors can repair the ACL with an operation called ACL reconstruction (ACLR). Torn ligament (tissue) is replaced to help your knee work well again. Surgeons are trying to make this operation work better. One way which may help is adding a strong, man-made tape inside the knee to help the new tissue heal, and add support. It鈥檚 being used more often by surgeons, but we don鈥檛 know whether this tape helps. We want to do this study to see if the tape helps knees heal better, and we want to see if it鈥檚 worth the extra money for the NHS.
You are being asked to take part because you have had an ACL tear and are going to have surgery to repair this. You also fit our other criteria, for example being 16 years old or older.
No, it鈥檚 up to you. If you don鈥檛 want to take part, it won鈥檛 affect the quality of care you receive.
Consent: We will ask you to give consent, showing you want to take part.
Group Allocation and Surgery: Before your surgery you will be placed into one of two groups (to have the operation with the tape or without the tape). You won鈥檛 be able to choose which group you鈥檙e put into, and you won鈥檛 know which group you鈥檙e in either. This helps to keep the study fair.
Questionnaires: We will ask you to complete some questionnaires before your surgery, and then 3, 6, 12 and 18 months after your surgery. This helps us to understand how well the operation went, how your knee is healing and how you are feeling. The answers will help us to evaluate whether the tape is effective and worth the money to the NHS. The questionnaires will take you about 20 minutes to complete at each timepoint.
18-month appointment: At around 18 months after your surgery, we鈥檒l ask you to see your hospital鈥檚 research team for a simple knee check called a pivot shift test. This is a routine test often done for people who have had ACL injuries and helps the team assess how stable your knee is. You may need to make an additional visit to your hospital for this.
Contact from us: We will contact you to ask you to fill in your questionnaires, and we will send you reminders if we don鈥檛 hear from you. We will also send you participant newsletters to keep you up to date with the study, and a link to the results at the end of the study.
We will collect details of your next of kin (if they agree) and we may contact them if you don鈥檛 complete your questionnaires. You can link them to the Data Information Leaflet on this webpage for more information.
The study is scheduled to last until the end of 2029, but you will be on the trial for about 18 months.
There is a possibility that we will contact you again in the next 20 years to see how your knee is doing.
This is a research study; it might help you, or it might not. What we learn from the study could help other people with knee injuries in the future.
You will not receive payment to take part, but we will reimburse you for your time in the form of vouchers. You will receive a 拢15 voucher at baseline and the 3, 6 and 12-month follow-up timepoints, and a 拢25 voucher at 18-months.
Both types of operations (with tape and without tape) are normally done in NHS hospitals. Joining the study doesn鈥檛 make your treatment riskier, because you are getting the standard care for your ACL. If you receive the tape, it will be CE marked which shows that the manufacturer has checked the product meets health and safety requirements and shows that it follows the law and is allowed to be used in the UK.
There are no special compensation arrangements. The University of 桃色视频 will arrange appropriate insurance for this study. If you are harmed due to someone鈥檚 negligence (e.g. not taking proper care), depending upon the problem, you may have grounds for legal action, but you may have to pay for it.
Depending upon the problem, NHS bodies are legally liable for the negligent acts and omissions of their employees. The University of 桃色视频 has insurance cover in the unlikely event of you being harmed whilst taking part in a clinical trial as a result of negligence on the part of a member of the study team.
Non-negligent harm by NHS staff is not covered by the NHS indemnity scheme.
If you have any concerns about any part of this study, you can contact the researchers at your hospital. Their contact details are on the Participant Information Leaflet that your hospital team has given you. There are also other contact details on here if you need them.
Yes, you can stop at any time and you don鈥檛 have to say why. You can also stop some bits, and not others, e.g. stop your questionnaires but your hospital will provide some follow-up data for you.
If you stop taking part, we will keep the information we already have about you. Your care won鈥檛 be affected.
In this research study we will only use information about you that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study. Everyone involved in this study will keep your data safe and secure.
For more information, please see the Data Information Leaflet on this webpage.
The University of 桃色视频 is in charge of the study. The 桃色视频 Clinical Trials Unit is helping to run it.
The study is funded by the National Institute for Health and Care Research, Health Technology Assessment (NIHR172043).
People who have had ACL surgery helped plan this study and have reviewed documents. Any research that involves the NHS and patients is reviewed by an independent group of people called a Research Ethics Committee. This study has been reviewed and been approved by the South Central – Oxford A Research Ethics Committee.
If you have answer questions, you can talk to your local research team. Their contact details are on the Participant Information Leaflet they gave you.
You can also contact the STRAP ACL team by emailing us at strapacl@warwick.ac.uk
Enquiries:
STRAP ACL Team:
Participant Information Leaflet
Data Information Leaflet