Information Summary

• This trial is for patients having the type of knee surgery called a high tibial osteotomy.
• The current surgery involves putting a standard “one size fits all” plate into your knee.  
• We want to know if a plate personalised to your knee, is better than the standard plate.
• Your doctors will have checked that you are eligible to take part. You can then decide if you want to or not.
• During your operation, the personalised plate will be inserted below your knee.
• We will ask you to fill out questionnaires about your health and lifestyle before and after your surgery for up to 12 months.
• You can leave the study at any time.

Frequently Asked Questions (FAQs)

What is the purpose of the PASHiOn study?

We would like to assess the safety of the new TOKA procedure when used during surgery for the first time.

Why have I been invited to take part in the PASHiOn study?

You have been invited to take part because you have already been offered the HTO operation to try to improve your knee symptoms.

Do I have to take part in this study?

No, taking part in research is always optional and if you do not take part, this will not affect the standard of care that you receive. If you do decide to take part, you will be asked to sign a consent form. You are free to leave the study at any point without giving a reason. One of the research team will talk to you about the study and answer any questions you have. You will also have a chance, if you wish, to discuss things further with the orthopaedic surgeon treating you.

What will happen to me if I decide to take part in the study?

As part of routine care, you will receive the usual NHS treatment and aftercare at your hospital.  If you decide to take place in this study, the personalised plate (TOKA) will be inserted during your operation. This is a personalised 3D printed plate, tailored to your knee. All patients participating in this study will be cared for as per standard practice while in hospital and will be asked to attend routine hospital appointments when discharged. If you experience any problems, the clinical team will review the situation and discuss future management with you.

What will I have to do if I am involved in the study?

Once you have read all the information about the study and have spoken to one of the research team, if you then decide to take part you will be asked to provide your written agreement to do so. We call this your ‘consent’. You will be asked to visit the hospital before your surgery to undergo a CT scan and to have data collected about your walking ability. You will also be asked to complete a questionnaire 6 and 12 months after your operation. This will be explained in further detail in the section below.

How will information about my treatment be collected?

We will collect information about your allocated treatment via:

Questionnaires: All patients will be asked to fill in a questionnaire which include some questions about you, your knee, and your general health. This should take about 15-20 minutes to fill in. We will ask you to repeat this at approximately 6 months and 12 months after your operation.  In the event that you forget to return a completed questionnaire, we will send you another one as a reminder, two weeks after the due date. Following this, if we do not receive a completed questionnaire, we will telephone you to ask you a few questions. The telephone call should only take about 15 minutes.

Video Vector Analysis (VVA): You will be asked to attend the hospital on two occasions: once before your operation and then again six months after your operation. One of the ways we will compare the results of the two different plates is by using a measurement technique called VVA. With this, we will be able to measure if the desired change in your knee joint has been achieved.

VVA involves walking in a laboratory specifically set up to look at people’s walking patterns. This takes about 20 minutes. You will be asked to walk normally, over a special platform whilst a video, focused on your legs, is taken of you before the operation, and then repeated approximately 6 months after your operation to see if your walking pattern has changed. Your knee will need to be visible during the appointment so you will be asked to wear comfortable, loose fitting clothing.  

Case Report Forms:  these will be completed by the local research team while you are in hospital.

Hospital scans: 

• X-Ray imaging: You will be asked to attend the radiology department at your hospital before your operation for an X-ray of your leg. The X-ray will also be repeated approximately 6 months after your operation. Along with your VVA, this will help us accurately measure if the desired change in your knee joint has been achieved. Both of these X-rays are routine care, which means you will have them even if you do not agree to take part in this study.
• CT scan:  You will be asked to attend the radiology department at your hospital before your operation for a CT scan of your leg, which is then used to make the personalised TOKA plate. The imaging information will also be used to further improve the design of surgical plates used in HTO in the future. This would not be part of your usual care.

Are there any risks to taking part in the study?

The HTO operation is already well established throughout the world as a treatment for arthritis of the knee. The risks of HTO surgery will have been explained to you by your surgeon at the time of listing you for the operation. We do not anticipate any problems as a result of being involved in this study. We are using a new design of personalised plate which has been approved for research purposes only, by the appropriate regulators, including the Medicines and Healthcare products Regulatory Agency (MHRA). The plate is not CE marked.

X-ray and CT scans are a form of ionising radiation, which can cause cell damage that may, after many years or decades, turn cancerous. We are all at risk of developing cancer during our lifetime. The normal risk is that this will happen to about 50% of people at some point in their life. Taking part in this study will add only a very small chance of this happening to you.

Any safety events will be reviewed periodically by an independent Data Monitoring Committee who will advise if there are any concerns during the study.

Are there any benefits to taking part in the study?

We cannot guarantee any benefit to patients who take part in this study. The results we get from the study are likely to benefit future patients with knee arthritis.

What are the alternatives to taking part in the study?

If you choose not to take part in this study, your usual care will not be affected and your surgeon will discuss your treatment options.

What happens at the end of the study?

After you have completed your final questionnaire (about 12 months after your operation) then you will have completed your involvement in the trial.

What will happen if I don't want to carry on with the study?

Your participation is voluntary and if you decide to take part you are still free to withdraw at any time, without giving a reason, and without your medical care or legal rights being affected. Your surgery and aftercare will continue regardless. If you do decide not to continue with the study or lose the ability to take part during the course of the study, we would keep and use any information you have given us up to that point, unless you tell us that you would like your information removed from the study.

If at any time during the study, you lose the capacity to provide on-going consent to continue, we will withdraw you from the research at that time but will use any data about your HTO operation that we have collected up until that time.

If before your operation you decide not to receive the personalised HTO plate and instead wish to receive the standard HTO plate, with your consent we would still continue to collect data from you.

What will happen to the results of the research study?

We hope to recruit 5 patients for this stage of the study. We will then recruit a further 88 patients from different hospitals across the UK for a larger scale trial.

The results of the study will be published in a medical journal.  A summary of the results will be sent to participants, along with links of where to go for further information. 

Will my General Practitioner/family doctor (GP) be informed of my participation?

With your permission, your GP, and other doctors who may be treating you, will be notified that you are taking part in this study. We may also contact your GP if we lose contact with you for the purpose of sending you the questionnaires.

What if there is a problem regarding my involvement in the study?

Taking part in this study does not affect your normal legal rights. Whether or not you take part, you will retain the same legal rights as any other patient in the NHS. If you have a concern about any aspect of the study, you should first speak with the researcher or your orthopaedic surgeon.

What if I am concerned about my clinical care?

The Patient Advisory Liaison Service (PALS) is a confidential NHS service that can provide you with support for any complaints or queries you may have regarding the care you receive as an NHS patient. 

Who is organising and funding this research?

The study is sponsored by The University of Bath and is managed by the Surgical Intervention Trials Unit, part of the Oxford Clinical Trials and Research Unit at the University of Oxford.   Professor Richie Gill is the Chief Investigator. The study is funded by Versus Arthritis. Versus Arthritis was formed in 2018 following a merger of Arthritis Care and Arthritis Research UK.

Who has approved this study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect participant’s interests. This study has been reviewed and given a favourable opinion by the London Stanmore Research Ethics Committee and approved by the Health Research Authority. . UK Comprehensive Research Network, independent researchers, patient representatives, each hospital’s Research and Development department and your healthcare professional have also reviewed and agreed to take on this study.

Are my expenses covered?

We appreciate the time and money commitment that you are making in helping our important research. For the extra visits associated with your involvement, we can contribute to travel expenses for you at public transport rates (fuel at approximately 40 pence per mile or bus/train fares) and also cover the cost of car parking.

What insurance arrangements are in place?

The University of Bath, as Sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this study. NHS indemnity operates in respect of the clinical treatment which is provided.