WWL Sponsored Studies

Chief Investigator: Prof Adam Watts

Fractures (break in the bone) of the olecranon (point of the elbow) are common and occur usually as a result of a fall onto the elbow. The risk of having this fracture increases as we get older. The bones typically move out of place due to the pull of the large triceps muscle on the back of the upper arm. Provided a patient is well enough, they usually have surgery to fix the fracture. How we keep the bone in the correct position is the subject of this study. The standard method is with metal wires, but these have to be removed in a second operation in a third of cases because of prominence. An alternative method of fixation may reduce this re-operation rate which is better for the patient and has the potential to save the NHS money.

The surgery is usually done as a day case with the patient asleep. A cut is made on the back of the elbow and the bone is put back into the correct position for the fracture to heal. The most widely used technique is to hold the bone with tension band wiring using metal wire bent around the bone and two smooth pins. This is usually effective in holding the position for the fracture to heal. However, the wires can cause pain when the patient leans on the elbow, because they lie just under the skin. Patients often ask the surgeon to remove the wires once the bone is fixed.  Complications can happen such as incorrect wire placement, joint penetration, injury to nerves and blood vessels, elbow stiffness, wires can push out through the skin, wires can break or the bones move out of position.

One in three patients will undergo a second operation with surgical risks and inconvenience to them and increased cost to the National Health Service. Alternative methods of holding the bone have been used, with very strong material cord (tension suture fixation) to counter the muscle forces pulling the bone out of position. Small studies have shown that this technique can reliably hold the bones in a good position while they heal and that the patient does not experience any discomfort from prominence of the suture material. The need for further surgery was reduced in one small study from over one in three patients to less than one in twenty. This could save the NHS about £4 million pounds a year but a larger study is needed to confirm this finding.

We successfully gained funding from the NIHR to compare the tension suture method of fixing the fracture to tension band wiring in a larger group of patients in several hospitals. This is a randomised trial in which neither the clinician nor the consenting patient would choose which fixation method is used. We will assess how well patients are able to manage daily activities, pain, quality of life and whether they need a second operation. Patients would need to attend clinic at four months for an x-ray and questionnaire, and will receive questionnaires at 12, 18 and 24 months by post or email. This will be followed by a telephone call if there is no response.

All other care would be routine care that they could expect if they had not participated in the trial. We have consulted with the Patient and Public Involvement Research Group at WWL who have contributed to the design and summary and agreed to provide advice during the trial. One member is a co-applicant on the bid. The protocol has been amended on their advice to include a standard information booklet for the patients recruited to the study to explain the likely recovery process and physiotherapy guideline.

Start date: November 2019

End date: April 2024

https://www.fundingawards.nihr.ac.uk/award/NIHR127739

WWL Sponsorship Team

• Joanne Farnworth, Research and Development Team Manager
• Dr Jane Martindale, Patient and Public Involvement Lead, Research Sponsorship Manager
• Linzi Heaton, Research Sponsorship Co-ordinator
• Malcolm Ryding, Co-applicant, Patient Representative WWL
• Jill Thomas, Co applicant, Physiotherapy Advisor

Delivery Team

• Valerie Parkinson, Research Nurse
• Amy Newell, Research Administrator

External Co-applicant Team

• Prof Joseph Dias, Co-applicant, University Hospitals Leicester
• Mr Andrew Duckworth, Co-applicant, Edinburgh Royal Infirmary
• Mr Paul Robinson, Co-applicant, North West Anglia NHS Foundation Trust
• Mr Joideep Phadnis, Co-applicant, Brighton and Sussex University Hospitals NHS Trust

York Clinical Trials Unit Team

https://www.york.ac.uk/healthsciences/research/trials/research/trials/sofft/#tab-1

• David Torgerson
• Catherine Hewitt
• Catriona McDaid
• Liz Cook
• Belen Corbacho
• Sophie James

Patient and Public Involvement

Click here to read a copy of the PPI report for the SOFFT study.

Acronym: HipHOP (Hip arthroplasty with Hybrid Or cemented implants: Patient reported outcomes)

https://www.fundingawards.nihr.ac.uk/award/PB-PG-0817-20012             

Chief Investigator: Professor Tim Board

Hip replacement is a common procedure, but patients vary in how well their hip works after surgery. The type of hip implant used may affect how successful the surgery is, but there is no clear evidence on which is the best type of implant. We are undertaking a trial of two types of implant. This is a feasibility study to see if a full trial is possible. Sixty patients from two hospitals will receive either a ‘cemented’ or a ‘hybrid’ hip replacement. Patients’ hip function will be assessed at 6 weeks and 6 months later using standard questionnaires.

Our main outcome is the rate of recruitment. We want to know how many patients will agree to take part, how long recruitment will take, and whether patients will complete the follow-up assessments after surgery. We will also learn how many patients will be needed for the full trial.

In interviews, we will ask patients about their experiences of the trial and their reasons for taking part; we will also ask people who declined about their thoughts. We will ask surgeons about their willingness to take part in a trial and about any barriers there might be to changing their surgery practice following the full trial results.

This topic of research has been discussed with patients at our WWL Patient and Public Involvement (PPI) group and they gave positive feedback that patients would be happy to take part. The PPI group will continue to be involved throughout the study, giving guidance with patient information sheets and letters. Our findings will be presented in scientific meetings, peer reviewed journals and shared with professional bodies. Our PPI group will be helping to advise on sharing the research findings in social media, newspapers and radio. If our study is successful, we would then apply for additional funding to complete the main trial.

Co-investigators:

Dr Cheryl Jones, Dr Rachael Powell, Dr Vikki Wylde, Miss Eftychia Eirini Psarelli, Mr Hiren Divecha, Mr Sion Glyn-Jones, Mr Sunil Panchani, Mrs Carolyn Lee, Professor Paula Ghaneh

WWL Team

• Tracey Taylor, Lead Clinical Research Nurse
• Joanne Farnworth, Research and Development Team Manager
• Dr Jane Martindale, Patient and Public Involvement Lead, Research Sponsorship Manager
• Linzi Heaton, Research Sponsorship Co-ordinator

Delivery Team

• Anne Evans, Research Nurse
• David Wilcock, Research Administrator
• Becky Smith, Research Administrator

The Liverpool Clinical Trials Centre, our partner organisation is responsible for delivery of the HipHop trial:

https://lctc.org.uk/About

https://lctc.org.uk/research/hiphop/

Assessing Post-operative Bleeding, Pain and Return to Work following Tonsillectomy: A multicentre prospective cohort study: POP-T (POST OPERATIVE TONSILLECTOMY QUESTIONNAIRE)

Chief Investigator: Professor Nirmal Kumar

Statistics Lead: Miss Sadie Khwaja

Project Co-ordinator: Mr Samit Ghosh

Project Co-ordinator: Mr John Rocke

Data Custodian: Mr Elliot Heward

Sponsorship Co-ordinator: Miss Linzi Heaton

Funder: BVM Medical Limited

The steering group has members of the North West Otolaryngology Research Trainee Collaborative.

Primary aim: What is the pattern of pain and bleeding in the post-operative phase of tonsillectomy?

Secondary aim: Do people seek medical attention when they suffer post-operative complications and when do people return to normal activity following tonsillectomy?

We know very little about the recovery of patients after their tonsillectomy operations. This is because we do not arrange follow up visits to a clinic. There has also been very little research in the past investigating this area. We want to be able to tell future patients how uncomfortable or painful a tonsillectomy operation might be and the risk of bleeding after the procedure. This information will allow us to more accurately explain to patients what their recovery will be like and advise them when they can go back to school or work.

Participants are given a simple patient diary to fill in each day by circling one option on each row for that day either for the adult or a child. The questionnaire asks about how bad pain has been and how much bleeding has been experienced that day. The diary is completed before going to sleep at night and takes around 1 minute each day for 21 days. Completed diaries are posted back to the study team in a stamped addressed envelope.

This study will aim to better understand the post-operative recovery period following a tonsillectomy operation. It will therefore help clinicians to counsel patients appropriately regarding their recovery, return to work or school and risk of complications. The results will also aid the creation of evidence based patient information leaflets. In addition, trainees who participate will gain valuable research exposure and skills during the study period.

ENT Trainee network collaboration:

Nirmal Kumar as GM CRN lead for ENT has helped establish a trainee network working across GM sites that is recruiting heavily to this trial through the pandemic. The benefit of the POP-T clinical trial is the participation from core and higher trainees in a portfolio adopted trial that improves understanding of clinical research early in the careers and during training allowing them to progress with academic activities alongside clinical training.

Elliot Heward comments from a trainee perspective:

‘The experience I have gained while developing and delivering an NIHR portfolio prospective multi centre cohort study alongside WWL as sponsor has been invaluable. Exposure to this study during my training has helped me understand the importance of sound study design and what is required to submit and ethics application. Having the ability to discuss the study with the PPI group at Wrightington was extremely helpful to shape the study design and certainly helped support the study application. 

The research team at WWL have been very supportive of our goal to improve ENT trainee engagement with research and have helped guide me through the research journey. The process of delivering a research study has been challenging and very rewarding.’ 

Funder: Symbios, Wrightington Wish Foundation, The John Charnley Trust

Chief Investigator

Professor Tim Board

Collaborators:

Edge Hill University: Dr Ben Langley, Professor Mat Greig, PhD student, Mr Adam Jones

WWL: Mr Jonathan Barrow, Mr Anil Gambhir, Mr George Pavlou, Mr Hiren Divecha

Myrecovery: Dr Axel Sylvan

Research Aims and Questions

The overarching aim of this project is to determine if there are any differences in the post-operative recovery and functional performance (joint movement/loading and muscle activation patterns) of patients who receive a standard or a custom Total Knee Replacement (TKR), compared to each other and healthy controls. The principle research question addressed within this study is:

• How does functional recovery compare after standard off-the-shelf or custom TKR during walking and activities of daily living?

To answer the research question comparisons between the standard and custom TKR groups will be made at various time points before and after the TKR surgery. Additionally, the joint motion, loading and muscle activation patterns will be compared to healthy controls to identify which group, if either, recovers to more “normal” patterns.

Secondary research questions associated with the study are:

1. How do joint movement and loading patterns compare between individuals who have undergone TKR and healthy controls during walking and activities of daily living?
2. How do muscle activation patterns compare between individuals who have undergone TKR and healthy controls during walking and activities of daily living?
3. How valid and reliable are knee joint angles recorded by the myrecovery.ai app?
4. How reliable is 3D movement analysis during walking and activities of daily living?
5. What are the smallest differences 3D motion analysis can accurately detect during walking and activities of daily living?

EHU Perspective on Collaboration

The partnership between WWL and Edge Hill University provides an exciting opportunity for clinicians and academic staff to work collaboratively to develop novel, world leading and ground-breaking research which has real world applicability. The collaboration has already enabled research active staff from several departments within the University to broaden their research portfolios, working alongside experienced clinicians. In addition, the partnership offers clinicians at WWL the opportunity to seek support from academics with expertise in biomechanics, epidemiology, health and social care, medical statistics, physical activity, and psychology through the Health Research Institute. Furthermore, the partnership provides staff at WWL with access to a state of the art facilitates such as a biomechanics laboratory housing a 3D motion capture system, Computer Augmented Virtual Environment (CAVE) and a clinical skills and simulation centre.

WWL Team

• Joanne Farnworth, Research and Development Team Manager
• Dr Jane Martindale, Patient and Public Involvement Lead, Research Sponsorship Manager
• Linzi Heaton, Research Sponsorship Co-ordinator

Delivery Team

• Sarah Liderth, Research Nurse
• Becky Smith, Research Administrator