Patient and surgeon considerations for revision knee replacement for unexplained, chronic pain

Plain English summary of protocol

Background and study aims
Around one-in-every-five patients reports chronic pain following knee replacement surgery. Many of these patients seek medical help, which prompts the search for a diagnosis to explain their symptoms. However, for a large proportion of patients, no cause is ever found and the pain is said to be ‘unexplained’. In this situation, current guidelines recommend initial supportive treatment (for example, with physiotherapy or pain management). Recent evidence suggests around two-thirds of patients will improve with this treatment. However, the remaining one-third of patients remain the same or are worse off. For these patients, the best treatment option is not known, and some patients request a surgical solution. However, surgery to revise a knee replacement for chronic pain is controversial. The surgery itself may be complex and carry a high risk of complications, whilst the odds of an improvement in symptoms are only about 50/50. Our understanding of the important considerations when deciding whether or not to operate for chronic pain are very limited. The aim of this study is to gain a deeper understanding of these considerations from the perspectives of both patients and surgeons. This study will involve interviews with patients and surgeons, which will take place either over the telephone, via videoconference [using Microsoft Teams] or in-person. These interviews will be recorded and analysed using qualitative research methods. This study may benefit patients and surgeons in the future by providing information on the considerations that should be borne in mind when faced with the clinical dilemma of whether to offer revision surgery to treat chronic pain after knee replacement.

Who can participate?
This study is recruiting patients who have unexplained pain after knee replacement and surgeons treating this condition.

What does the study involve?
The study will involve completing a short data collection form to capture information on your background (age, gender, ethnicity, marital status, employment status, dependents, living arrangements, other health conditions, hobbies). This will be followed by an interview where we will ask you about the problems that you have had with your knee replacement, how these have affected you and your thoughts on the role of revision surgery for this problem.
 
If you decide that you would like to take part, Mr Shiraz Sabah (who is a trainee surgeon undertaking this research as part of a PhD) will contact you to complete a consent form and schedule an interview. The interview will last around an hour. He will discuss with you how you would prefer to be interviewed, with options to do this face-to-face, as a video call or over the telephone. The interview will be audio recorded with consent so that it can be analysed later and sent to an approved transcription service so that it can be typed up word-for-word. The transcription service will be required to delete the recording once the transcript has been returned to us and checked. The researcher will remove information such as names and places that can be used to identify you and add your transcript to our research software under an anonymous identifier (e.g. Participant 1). After we have analysed the interview, we will ask you if you would like to receive a summary to check that we have correctly understood what you told us. We will invite you to provide any feedback or clarifications, but this is optional. We will then write up our findings as a research paper for publication. With your permission, we may use some direct quotations that you have provided us in our reports and publications. These will be anonymised so that they cannot be used to identify you (e.g. Participant 1). We will send you a summary of our main findings at the end of the study.

What are the possible benefits and risks of participating?
This study may not benefit you directly. However, it may benefit patients and surgeons in the future by providing a better understanding of the considerations that are important to you and other patients with chronic pain after knee replacement.

Where is the study run from?
The study is running from the Nuffield Orthopaedic Centre, Oxford and is sponsored by the University of Oxford (UK)

When is the study starting and how long is it expected to run for?
September 2021 to February 2023

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Mr Shiraz Sabah (shiraz.sabah@ndorms.ox.ac.uk)

Contact information

Mr Shiraz Sabah
Scientific

Botnar Research Centre
NDORMS
Old Road
Headington
Oxford
OX3 7LD
United Kingdom

ORCID ID	0000-0003-2401-1372
Phone	+44 7956 534625
Email	shiraz.sabah@ndorms.ox.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

University of Oxford
University/education

Joint Research Office
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom

Phone	+44 1865 616480
Email	ctrg@admin.ox.ac.uk
Website	https://www.ndorms.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

42045 Protocol v1.1 14Apr2022.pdf

42045 PIS v1.1 14Apr2022.pdf

Editorial Notes

09/01/2024: Internal review.
12/07/2022: Trial's existence confirmed by NHS HRA.