Please note the UKSTAR trial is no longer recruiting participants. Interested patients were invited to read the information below.
If you tear your Achilles tendon, you are eligible to be part of this research project.
You also have to meet the following inclusion criteria:
- aged 16 years or older
- have a primary rupture of the Achilles tendon
- have decided to have non-operative treatment
and not meet these exclusion criteria:
- arriving at the treating hospital more than 14 days after the injury
- some evidence of being unable to adhere to trial procedures or complete questionnaires; for example, a history of permanent cognitive impairment.
Do I have to take part?
It is entirely your decision whether you choose to take part or not. Throughout the study, you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time or a decision not to take part will not affect the standard of care you receive. However, we will not be able to remove the data we have already collected prior to your decision to withdraw.
A decision to withdraw at any time or a decision not to take part will not affect the standard of care you receive.
When you decide to take part in the trial ...
If you decide that you would like to be involved in the research study you will be asked to sign a consent form. You will then be allocated to receive either a Plaster cast or a Walking boot. The treatment you receive will be allocated using a computer. You have the same chance to be entered in the plaster cast group as in the walking boot group. You will be followed up according to the usual treatment at your hospital, in the same way as patients not taking part in this study. The only additional commitment we would ask of you would be to fill out a questionnaire on four occasions during your recovery.
The only additional commitment is to fill out a questionnaire on four occasions during your recovery.
The research team at the hospital will ask you to fill out a questionnaire at 8 weeks, 3, 6 and 9 months after your injury. The questionnaire will either be sent to you in the post or by email as you prefer. If we send it out in the post, we will provide you with a stamped addressed envelope to send it back to us once you have filled it out so there are NO costs involved.
No costs involved.
When the cast/boot is removed after 8 weeks, we will provide you with written advice about the exercises you need to perform to strengthen your calf muscles and support the healing tendon.
When the cast/boot is removed after 8 weeks, we will provide you with written advice about the exercises you need to perform to strengthen your calf muscles and support the healing tendon. The advice has been put together for research trials into Achilles Tendon Rupture, with the help of a large group of physiotherapists and doctors around the country. The advice is the same for patients with the walking boot and the plaster cast.
Will my taking part in this study be kept confidential?
A copy of your consent form and paperwork will also be held by the STAR trial team at the University of Oxford. Only appropriate personnel will have access to your record and all information will be treated with the strictest security and confidentiality.