The OPAL Trial: Frequently asked questions

Hip and knee arthritis causes pain which limits daily activities and can make it difficult to work. Hip and knee replacements can relieve pain and improve function and can help many patients of working age continue working or get back to work.

We understand the issues patients face when returning to usual activities and work after hip and knee replacements. We have used this understanding to improve care and develop a support programme to help people return to work and usual activities.

We are inviting patients that are in work and plan to return to work after their hip or knee replacement to join the OPAL trial.

We are interested in supporting people in a number of different work roles including those in full or part-time paid employment, those that are self-employed, and people who work as volunteers and carers.

The OPAL Trial is running across at a number of hospitals across the UK. Please ask your hospital team if they are involved and whether you can take part.

Patients about to have a hip or knee replacement that are working and intend to return to work after surgery, will be identified by a member of their care team as a “return to work patient”. They will pass on details of these patients to a member of the research team who will contact the patient to explain the OPAL Trial and seek their consent to participate.

If the patient decides to take part, they will be allocated to one of the two groups at random after completing the consent form. Patients are allocated to a group using a computer, meaning they, their care team or the researchers cannot choose which group they are in.

The two groups are the “OPAL Occupational Support Programme” and “Study Standard Care”.

We have designed the OPAL support programme to help people return to work and their usual activities after surgery. However, we do not know if it is better than the standard care currently given after hip or knee replacement. The OPAL Trial will help us to assess this.

There are no particular risks associated with this trial. 

The results of the OPAL Trial may be presented to other researchers, at conferences and through publication in scientific journals. Results of the Trial may also be used to support other research in the future, such as health-based research and may be shared anonymously with other researchers.

We will ensure that it will not be possible for anyone to identify any patients involved in the Trial from the published findings.

We will follow established ethical and legal practices. All information collected about you during the study will be kept strictly confidential, safe and secure. Data collected for the study will only be looked at by authorised persons who are organising the research and to check the study is being carried out correctly.

All data about you will have your name and address anonymised and a unique code will be used to help protect your identity. Any information collected about you will be stored in a secure location and electronically on a password protected database. All our reports will be written anonymously so no one can work out you took part in the study.

All personal and research data will be held for up to 5 years in case we need to contact you about the findings of the study unless you ask us not to contact you. Your personal and research data will be disposed of securely after it is no longer necessary to contact you.

As requested by the funder, we will ask for your consent to link the data collected from the study to routinely collected health data stored in national databases (via your NHS number), and to share this information anonymously with other researchers.

If you wish to raise a complaint on how we have handled your personal data, you should contact the research team. If you are not happy after that, you can contact our Data Protection Officer who will investigate the matter. If you are not happy with our response or believe we are processing your personal data in a way that is not right or lawful you can contact the Information Governance Team at the Sponsor’s organisation in the first instance, who may escalate the issue to either the Data Protection Officer or Caldicott Guardian. If you remain unhappy, you can complain to the Information Commissioner’s Office (ICO).

The OPAL Trial is organised by South Tees Hospitals NHS Foundation Trust in collaboration with the University of Nottingham and the University of York. The trial is funded by the National Institute for Health and Care Research, Health Technology Assessment Programme (NIHR133880).

All research in the NHS is reviewed by an independent group of people, called a Research Ethics Committee (REC), to protect the interests of the patients involved in the research.

The OPAL Trial has been reviewed and given favourable opinion by the Egbaston Research Ethics Committee and approved by the Health Research Authority (HRA) (REC Ref Number 23/WM/0013; IRAS project ID 320809).