Trust Board Meetings 2021/2022

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Due to the impact of COVID-19, the Trust Board will meet “virtually”.

Trust Board papers will still be published on this website, and interested members of the public are invited to submit questions to trust.secretary@nbt.nhs.uk in line with the Trust’s normal processes. Public meetings will be recorded and uploaded to this page ASAP after the meeting and will be available for viewing for two months following the meeting, when the next meeting’s recording will be uploaded.

The Trust Board meets in public at 10am.

  •  Thursday 27 May 2021, Virtual
  • Thursday 29 July 2021, Virtual
  • Thursday 30 September 2021, Virtual
  • Thursday 25 November 2021, Virtual
  • Thursday 27 January 2022, Virtual
  • Thursday 31 March 2022, Virtual

 

Download Integrated Performance Reports (IPR):

Download Meeting Papers:

Download Final Minutes:

 

Medical Examiner Office

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Medical Examiner Office

Following a bereavement, many families seek reassurance that their loved one was properly cared for in hospital and want to understand the circumstances surrounding their death.

The Medical Examiner service has been introduced in England and Wales to increase understanding and peace of mind for families, as well as improve learning and patient safety in hospital by providing a review of care. This new service will be introduced into law in 2022.

Medical Examiners are independent senior doctors who have not been involved in the care of the person who has died. Talking with a Medical Examiner can help you to understand the cause and circumstances of death. It also provides an opportunity to discuss any issues, concerns, or feedback regarding care that you may have with an independent team.

Our team of Medical Examiners and Medical Examiner Officers work closely alongside existing Bereavement Services. If you would like to get in touch, please call the Medical Examiner Office and a member of our team would be happy to speak to you.

 

Office opening times/phone numbers:

The Sanctuary (Gate 30, Level One), Brunel Building, Southmead Hospital

Office hours – 08.30-16.30

0117 414 3447/3448

Women and Children's Current Research

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The Women and Children’s Research Unit conducts research that aims to improve the care of women and children using Obstetrics and Gynaecology services. This includes pre-conception services through to postnatal care.

The Unit collaborates widely with other disciplines and professions, as well as with women and their companions, to develop ground-breaking research and care, for our patients and throughout the NHS.

Please speak to the person treating you to find out if there is a research study that may be able to help you.

Maternity Studies:

Generation Study

The Generation Study is a national research study that will sequence the genomes of 100,000 newborn babies to test for more than 200 rare and treatable genetic conditions. 

Identifying these conditions shortly after a baby is born, rather than when symptoms might appear later in childhood, means families can receive support, monitoring, and treatment much earlier. Early, effective intervention can help to prevent longer term health problems associated with certain conditions, keeping children out of hospital, and helping them live healthier lives. 

The Generation Study, led by Genomics England in partnership with NHS England, will see parents offered whole genome sequencing using blood samples taken from the umbilical cord shortly after birth.

In Bristol, Southmead Hospital (North Bristol NHS Trust) and St Michael’s Hospital (University Hospitals Bristol and Weston NHS Foundation Trust) are among more than 20 hospitals nationally taking part.

Women planning to give birth at home may also take part in the study. Expectant parents will be informed about the Generation study during pregnancy, and if interested, a research midwife will have a detailed conversation with them to decide if they want to take part. Taking part is voluntary and free. Soon after birth, an NHS doctor, nurse, or midwife will check with parents that they are still happy for their baby to be tested, and a blood sample will be taken and sent to a laboratory for whole genome sequencing.    

Results are then reviewed by NHS genomic scientists. The aim is to share results with parents within 28 days if a condition is suspected, or within a few months if no conditions are suspected. 

If a newborn baby is identified as having a treatable childhood condition through the genome sequencing, families and carers will be provided with further NHS testing to confirm a diagnosis and will receive ongoing support and treatment from the NHS. 

The study will also gather genomic data for wider research purposes, allowing a better understanding of rare genetic conditions. It will also potentially pave the way for new diagnostic tools and treatments and improvements in existing therapies.

In addition, the Generation Study will explore the risks and benefits of storing an individual’s genome over their lifetime. This could allow it to be reanalysed later in life if needed, enabling access to new developments in genomics.

For further information on the Generation Study, visit: www.generationstudy.co.uk

Principal Investigator – Dr Christy Burden 

Planned end date – Currently 31/03/2025.

Local Ref – 5527

DIvO Study

 Digital Imaging versus Opthalmology for congenital cataract screening

About 1 in 3,000 babies are affected by cloudiness of the lens of the eye (cataract) and, in the majority of cases, both eyes are affected. Since a baby’s first months are a critical time for vision and brain development, early surgery is needed to prevent permanent visual impairment. For this reason, cataract is the most common cause of preventable child blindness worldwide. All babies born in the UK are examined (screened) for cataract twice: first, within 3 days of birth in the maternity unit, and then again at the 6-8 week check by their GP. Despite this, late diagnosis of cataract continues to be a problem, causing avoidable visual impairment in some affected children. In the standard examination test, midwives or doctors shine a bright white light torch (an ophthalmoscope) into the eye to assess the reddish reflected light (red-reflex), similar to “red eye” seen in flash photos. Cataract blocks the light reflection causing an absent or dim red-reflex. The test can be difficult to perform because the bright light causes the pupils to constrict and the babies to shut their eyes. The assessment is particularly difficult in babies with dark eyes since eye pigmentation affects the colour and brightness of the red-reflex. Recently, a handheld, non-contact camera, called Neocam, has been developed which takes a picture of the eyes using both infrared and green light. Previous small-scale studies have shown that this technique, called photoscreening, can make childhood cataract detection easier.  In this study, we want to find out if photoscreening is more accurate than the standard test for detecting cataracts in newborn babies.

Visit Divo website to complete the self-enrolment form.

Project Details

Principal Investigator: Dr Daniela Vieten-Kay

Planned end date: 30/6/2024

Local Ref: 5426 

Pioneer

A team of researchers and clinician are conducting a study of the use of a medication called Pravastatin by pregnant women who have been identified as being at higher risk of their babies being born too early (preterm birth).

Preterm birth is birth that happens before 37 weeks of pregnancy. It affects around seven out of every 100 babies born in the UK. We do not fully understand why some babies are born too early and at present there are few effective treatments to prevent this from happening. Research shows it is likely that early labour may occur in some pregnancies because of inflammation in the mother’s body. Taking a medication that reduces inflammation, such as Pravastatin, could therefore reduce the number of babies being born too early. Pravastatin is a statin, and statins are a group of medicines which are commonly taken to help lower the risk of heart disease and stroke. Statins work by protecting blood vessels and lowering inflammation in the body.

During the past couple of decades, Pravastatin has been used during pregnancy in studies which have investigated whether Pravastatin prevents or treats other problems/complications of pregnancy. In total 1,303 pregnant women took part in these studies, which showed that there were no safety concerns or problems regarding the baby’s development.

In fact, these studies suggested benefits to the baby, as they found evidence that Pravastatin reduced the number of babies born early. This is what PIONEER will now test. Based on this information, we are interested to find out whether treatment with Pravastatin reduces the chance that a woman will give birth early by: 

  • extending the length of pregnancy
  • reducing the risks associated with babies being born too soon. 

We would also like to find out how Pravastatin might work to reduce early birth by looking at blood samples, vaginal swabs, and stool samples taken from pregnant women who take part in the study.

Everyone who takes part in PIONEER will be randomised into one of two groups: one group will take Pravastatin and the other group will take a placebo (a dummy tablet which looks like Pravastatin but does not contain Pravastatin, only an inactive substance). An equal number of pregnant women will be placed in each group. The aim is to have two groups that are as similar as possible at the start of the study, so that the only thing that differs between the groups is whether they receive the Pravastatin or the placebo. This then allows a fair comparison between the two groups to see if there are differences between the groups in the number of babies born early.

For more information, please visit the study website www.bristol.ac.uk/pioneer

Principal Investigator – Dr Sherif Abdel-Fattah

Planned end date – 31/03/2027.

Local Ref - 5406

CoCo90s

Children of the 90s is a group of around 14,500 children born in the Avon area in 1991 and 1992. Scientists have been studying them ever since and are constantly making discoveries that make a difference to lives around the world.

Some now have children of their own, and we want to follow these pregnancies, births and babies. We call this Children of the Children of the 90s, or COCO90s for short. This is the only project we know of that provides scientists with information on three generations, allowing them to study important social and health issues.

If you or your partner are in Children of the 90s and are about to become or are already a parent, we'd love you, your partner and all your children to take part in COCO90s. It doesn’t matter how much or how little you have been involved in Children of the 90s in the past -- this is a new opportunity to be involved in ground-breaking research.

For more information about this study, visit the CoCo90s website.

Project Details
Principal Investigator: Ms Mary Alvarez
Planned end date: Ongoing
Local Ref: 2801

NICU Studies:

Dolfin

Aim: The DOLFIN trial is a research study looking at whether giving a specially developed nutritional supplement via breast or formula milk for the first year of life helps with brain development. If your baby was born less than 28 weeks old or is receiving cooling therapy, you may be approached about the study.

Recruitment: 30 babies born at less than 28 weeks or receiving cooling therapy.

A small UK study has been carried out and the results were promising, but we need to find out more.  About 500 babies nationally will take part in the study so that we can find out whether the supplement improves neurological child development. Half will receive the nutrient supplement and half will a get a dummy (placebo). You will not know which treatment your baby will receive.  Joining the study involves you giving the supplement daily to your baby until the date they would have turned one.

For more information, please visit the DOLFIN trial website.

Project Details
Principal Investigator: Dr Amiel Billietop
Planned end date: 31/05/2024
Local Ref: 5131

POLAR

Aim: This research project compares two ways we may adjust a commonly used treatment, called positive end-expiratory pressure (or PEEP), to help premature babies’ lungs in the first few minutes after birth.  

Recruitment:  80 babies born before 29 weeks of pregnancy.

The POLAR Trial is a large clinical trial, being conducted in 25 hospitals around the world, including Australia, Europe, the United Kingdom and the USA.

​This trial will establish how to best support the fragile lungs of very premature babies born between 23 and 28 weeks of pregnancy immediately after birth.​

We are comparing two approaches to PEEP levels given to preterm babies’ lungs at birth. We will put your baby into one of two groups, static or dynamic PEEP.  

All the babies in the same group receive the same treatment.  The results are later compared to see if one is better. 

For more information, please visit the POLAR study website.                                                                                          

Project Details
Principal Investigator: Dr Charles Roeher
Planned end date: 30/06/2026
Local Ref: 5152

SurfOn

Aim: To investigate whether in late preterm and early term infants with respiratory distress the early use of surfactant versus expectant management results in a shorter duration of hospital stay and fewer infants who fail to respond to treatment.

Recruiting: Infants born between 34+0- and 28+6-weeks’ gestation admitted to a Neonatal Unit (NNU) with respiratory distress and for whom a clinical decision has been made to provide non-invasive respiratory support.

For more information, please visit the SurfOn website.

Project Details
Principal Investigator: Dr Amiel Billietop
Planned end date: 28/02/2025
Local Ref: 4949

WHEAT

Aim: The WHEAT International trial will compare two different approaches, feeding babies or not feeding babies during blood transfusions, to work out which one is better. 

Recruitment: We are including all babies that are born before 30 weeks of pregnancy. The WHEAT study is an opt-out study.  This means that all babies will take part unless you let a member of the neonatal team that you do not wish your baby to participate. 

Both approaches are standard practice in the UK but we don’t how best to feed babies during blood transfusions – some hospitals and doctors stop feeds while other don’t. 

Some babies who are born early can develop a bowel disease called necrotising enterocolitis (NEC) which can be serious and can have long-term effects on how babies grow and develop. We want to know if feeding babies or not feeding babies while they have a blood transfusion changes the number of babies that get NEC.

WHEAT is taking places in neonatal units across the UK and Canada and will involve about 4,500 babies.

Project Details
Principal Investigator: Dr Daniela Vieten-Kay
Planned end date: 31/12/2025
Local Ref: 5236

neoGASTRIC

Aim: The neoGASTRIC study is looking at whether routinely measuring gastric residual volumes (checking what is in the stomach before feeding) helps babies safely get to full feeds more quickly. We are comparing two ways of caring for babies having tube feeds, both ways are standard care commonly used in neonatal units across the UK.

Recruitment: We are including all babies born 6 or more weeks early (before 34 weeks of pregnancy) who require tube feeding unless there is another medical reason why they should not take part. All babies will be in the study unless you let a member of the neonatal team know that you do not wish your baby to take part.

Some doctors and nurses routinely measure gastric residual volumes because they think it might help tell if the baby is coping with their feeds, and may help identify signs of a serious but rare gut disease called necrotising enterocolitis (NEC). Other doctors and nurses think that routinely measuring gastric residual volumes may not be a good idea because it can be inaccurate and we do not know if it does help to identify necrotising enterocolitis (NEC). It also increases the amount of procedures each baby has, and may be uncomfortable for them. Routinely measuring gastric residual volumes may also lead to feeds being reduced or even stopped, this will delay the time it takes for the baby to reach full feeds and might affect how well they grow. It will also mean a baby will need intravenous nutrition for longer which can lead to potential problems like infections.

In the UK about half of doctors and nurses routinely measure gastric residual volumes and about half don’t – so both approaches are standard treatment. 

The study is being run in more than 30 hospitals in the UK and Australia for about 3 to 4 years. We hope to include over 7000 babies in the study (UK and Australia combined).

Project Details
Principal Investigator: Paula Brock
Planned end date: 31/06/2026
Local Ref: 5298

Gynaecology Studies:

Take Part in Research

Patient & Doctor viewing an x-ray

Become one of the thousands of people taking part in research every day within the NHS.

About Research & Development

NBT Researcher

Find out more about our research and how we're working to improve patient care.

Contact Research

Research & Development
North Bristol NHS Trust
Level 3, Learning & Research building
Southmead Hospital
Westbury-on-Trym
Bristol, BS10 5NB

Telephone: 0117 4149330
Email: research@nbt.nhs.uk

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Rheumatology Specific Condition Information and Specialist Clinics

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Ankylosing Spondylitis (AS)

We offer dedicated multi-disciplinary clinics with physiotherapy and specialist nurses.

A well established number of patients are on Biologic Therapy

Find out more information about AS and different treatments.

NASS Bristol (National Ankylosing Spondylitis Society) has been running groups from Southmead Hospital since 1998. Since March 2020, we moved to online stretch sessions due to COVID-19.

We run physiotherapist-led online stretch sessions every Monday afternoon at 1pm and on Wednesday evening at 6:30pm.

If you’re interested in joining in, we ask you to email and we will send you a medical questionnaire for you to complete before starting the session.

Find out more on the Nass Bristol website

Connective Tissue Disease Vasculitis

There are dedicated clinics at Southmead Hospital Bristol for new and follow up patients. The service is run by Dr Harsha Gunawardena, Dr Sam Patel and Dr John Pauling, supported by a specialist nurse and pharmacist.

We have experience in management of all autoimmune connective tissues diseases such as:

We take referrals from GPs and other hospital doctors (tertiary referral) for the more complex cases requiring high level expertise, such as inflammatory muscle disease, systemic sclerosis, and vasculitis.

We prescribe advanced therapies only available at a specialist centre including cyclophosophamide and Rituximab on Medical Day Care. 

For more information on drug treatment in rheumatology please visit the Versus Arthritis website.

Combined clinics with other specialist centres and specialties including Respiratory medicine (interstitial lung disease) and Royal Free Scleroderma service for complex conditions.

Combined clinics

Respiratory CTD Lung ILD Combined Clinic

Week 1 and 3: Dr Adamali and Dr Barratt and Dr Harsha Gunawardena for patients with lung disease secondary to autoimmune connective tissue disease or vasculitis.

Royal Free North Bristol systemic sclerosis outreach clinic

Held every 6 months with Professor Chris Denton and Dr Voon Ong of the Royal Free Hospital, London and Dr Harsha Gunawardena for patients with complicated systemic sclerosis (scleroderma).

Combined Rheumatology and Neurology neuromuscular metabolic bone disease clinic

Held every three months with Dr Emma Clark and Dr Andria Merrison

Osteoporosis

We hold a specialised osteoporosis and metabolic bone disease clinic at Southmead Hospital Bristol with Professor Tobias and Dr Emma Clark.

We have a DEXA scanner (to measure bone density) at Southmead Hospital Bristol. We often do an additional scan as part of standard DXA scans to look at the spine for vertebral fractures (VFA). We have good links with our radiology colleagues and can offer vertebroplasty if it is required.

We also have two dedicated osteoporosis specialist nurses.

Specialist therapies such as Denosumab injections are administered within the nurse clinic and Zoledronic acid infusions are administered on the medical day care unit.

The Royal Osteoporosis Society has up to date information on understanding osteoporosis, the treatments available, information on exercise diet and lifestyle, and local support in your area, please visit the Royal Osteoporosis Society website.

We have close ties with the physiotherapists, elderly care services and the falls services.

Our fracture liaison service is led by Dr Katherine Walsh and Dr Bailey, who are orthogeriatricians assisted by a fracture liaison nurse. The service is designed to identify new patients of 50 years and over who have sustained low trauma fractures injuries (equivalent to fall from head height or less). 

The nurse offers telephone follow up to patients with a high risk of future fracture to assess adherence and tolerability of bone protection medication. Where patients have not started treatment or there are medication issues they will be contacting patients to help resolve any issues.

Further information can be found on the Versus Arthritis Website.

Giant Cell Arteritis

We have a Rapid Access “Hot” Clinic for people suspected to have giant cell arteritis (GCA) with referrals from GPs and also within secondary care.

You will have an urgent appointment arranged and a temporal artery ultrasound carried out.  A further follow up will be planned if Giant Cell Arteritis is diagnosed.

Further information can be found on the Versus Arthritis Website.

Rheumatology bDMARD | tsDMARD therapy (Biologics Medication)

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If your arthritis is not well controlled on conventional therapy, your treatment may be escalated to either a biologic disease modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease modifying anti-rheumatic drugs (tsDMARD). If your Consultant thinks this is the most appropriate treatment option for you, you will have an appointment with a specialist nurse or specialist pharmacist to discuss starting treatment.  

These therapies are either administered via an infusion (‘drip’) in the hospital’s Medical Day Care Unit or supplied by a home delivery company and injected at home (and some of the newer therapies can be taken in tablet form).  The specialist nurse or specialist pharmacist will discuss different treatment options with you, including the risks and potential benefits.  Once you have commenced treatment, you will be followed up under the new bDMARD | tsDMARD monitoring pathway.

Some of the follow up appointments will be in a special type of remote consultation, called the Remote Therapy Clinic (RTC).  These will either be routine RTC appointments where we will send you an appointment letter inviting you to the consultation or they might be ad hoc RTC appointments where we will review your clinical information and might call you out of the blue (for example if we have been informed that you are running out of medication supplies).  If we send you an invite letter to a routine RTC appointment (see example letter below) it is important that you carry out the required steps before your appointment.  This includes having up to date blood tests at your GP surgery and completing your disease activity assessment scores on the disease activity tracking application if you have a smart phone.

Read more information about Biologic and Targeted Synthetic DMARDS in our patient information leaflet.

Discharge Advice After an Epidural or Spinal Anaesthetic

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If you have received an epidural or spinal anaesthetic during the delivery of your baby this information is to provide advice after you are discharged home. It explains symptoms to look out for in the days after the procedure and how to get in touch with us if you have any concerns. We hope that you are satisfied with your anaesthetic care, but if you have any concerns please do get in touch. We are always happy to answer any questions.

 

Headache

Having a headache is not uncommon after giving birth and usually occurs as a result of disrupted sleep, dehydration and tiredness. Around 1 in 100 people who have an epidural or spinal anaesthetic may develop a specific form of headache called ‘post dural puncture headache’. This usually occurs within a couple of days of the anaesthetic but may appear up to a week after the procedure. It tends to be worst on sitting up and walking and can be accompanied by neck pain, nausea, change in hearing and a dislike of bright lights.

If you develop a headache after discharge:

  • Drink plenty of fluids
  • Take simple painkillers regularly such as paracetamol and ibuprofen
  • Contact us for additional advice and follow up. A post dural puncture headache may settle on its own over a few days for some people, but others may need to come to hospital for a treatment called an epidural blood patch.

 

Other symptoms

The following symptoms may be signs of rarer but serious complications. Contact us if you experience any of these so that we can advise and assess you appropriately.

  • Redness, pus, tenderness or significant pain at the anaesthetic insertion site
  • High temperature or experiencing a stiff neck
  • Any numbness or weakness in your legs or buttocks
  • Inability to stand up
  • Difficulty passing urine or incontinence of faeces

 

How to contact us

Please ring the Central Delivery Suite on 0117 41469160117 4146917 and ask to speak to a member of the anaesthetic team who are available 24 hours a day.

Orthopaedics Current Research

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The Avon Orthopaedic Centre, based at North Bristol NHS Trust, has a long history of being one of the leading centres in the country for research and innovation in orthopaedic care.

The Bristol Medical School Musculoskeletal Research Unit are also based within the site, with this partnership enabling clinicians and research methodologists to closely collaborate both locally and internationally to deliver high quality research based on our multidisciplinary expertise.

Please speak to the person treating you to find out if there is a research study that may be able to help you.

An integral part of the Severn Major Trauma Network (SMTN) based at NBT, this highly skilled team are able to include patients in the crucial early phases post traumatic injury in a sensitive and caring manner.

Trauma & Orthopaedics Studies:

*SMTN specific-research

REACH

This study will compare two different ways, to help people with their recovery from a broken shoulder. Patients with this injury are usually referred for physiotherapy appointments for advice on how to get their arm and shoulder working again

In this study, patients will be asked to follow one of two rehabilitation programmes. They will either be offered:  Outpatient physiotherapy appointments to be shown what exercises to do or advice and information about a self-directed exercise programme that can be done at home. Advice will be given by a health professional in the hospital clinic, and you will also be given a high-quality workbook to help guide your recovery. 

PI: Rhian Witham 

Start Date: Jan 2025

End Date: Dec 2026

Local Ref: 5639

IMPACT

Evaluation of safety and efficacy of a resorbable collagan IMplant in treatment of High Grade PArtical thiCkness Tear; A prosepctive, mulitcentre, randomized, control trial.

Patients who are 18 years and over, with a partial rotator cuff injury who’s symptoms persist following 3-6 months of conservative treatment are eligible for this study.

Impact study compares two types of surgery:

The rotator cuff is a group of muscles and their tendons that act to stabilize (hold in place) the shoulder. Torn rotator cuff tendons are common injuries that result in shoulder weakness and pain. These injuries can be treated with medications, injections, and physical therapy. However, when symptoms continue despite these treatments, surgery is often recommended to repair the injured tendon. An alternative to standard surgical procedures for repairing torn rotator cuff tendons involves applying a protective layer of collagen over the injured tendons to aid in healing and stop disease progression. Collagen is the most commonly found protein in the body and is present in the skin, bones, tendons and ligaments. The collagen is extracted from bovine Achilles tendons (from cows).  

The purpose of this study is to find out if the marketed REGENETEN™ Bioinductive Implant is better than standard repair techniques for surgically treating partial-thickness rotator cuff tears. Smith+Nephew is the company paying for the study and REGENETEN is one of their products.

Project Details:

Principal investigator: Iain Packham

Start date: March 2023

End date: June 2026

Local ref: 5311

POP-I

Peri-Op Iron and Erythropoietin (EPO) Intervention Study 

Anaemia after major emergency surgery in older people with hip fractures is common and is associated with increased mortality, longer length of hospital stay and poorer quality of health. The POP-I trial aims to recruit patients 60 and over, who are anaemic in the postoperative period following either hip fractures. Participants who give their consent will be assigned randomly into one of three study groups: Usual care, Iron Infusion, or iron infusion and an injection that will stimulate red blood cell production.

PI: Katherine Walsh 

Start Date: Nov 2024

End Date: July 2025

Local Ref: 5535

WISE

This study will explore if additional exercise advice for people aged 50 and over who have broken their wrist helps with recovery.

After breaking their wrist, people are often provided with basic advice by the person who is treating them about how to get their wrist working again. WISE would like to find out if more detailed exercise advice given by a Physiotherapist will improve how quickly and how well they recover from a broken wrist.

Project Details:

PI: Mr Alasdair Bott

Start Date: Mar 2024

End Date: Feb 2025

Local Ref: 5452

REPPORT

This study aims to find out the best treatment for patients 16 years and over with repeated dislocations of their kneecap (patella). The study is comparing personalised knee therapy, delivered by a Physiotherapist, to surgical stabilisation for improving patient function following repeated dislocation.

Project Details:

PI: Mr Damian Clark

Start Date: Dec 2023

End Date: Aug 2025

Local Ref: 5440

DIDACT

This study compares surgery to sling immobilisation in the management of adults with a displaced fracture of the distal clavicle (Collarbone) in patients over the age of 18 years old with 21 days of injury. 

When the outer end of the collarbone has broken, parts of the bone may separate and not line up. This can rupture the ligaments connecting the collarbone to the shoulder blade. Doctors commonly treat this type of injury that have had with: A sling, to help support the shoulder while the bone heals naturally; or surgery that uses metal work to try the separated bone while they knit together naturally.  Both treatments work but we do not know which one works the best. The aim of this study is to find this out. 

Project Details:

PI: Iain Packham 

Start Date: December 2023

End Date: 30 June 2025

Local Ref: 5405

WHITE 15 – INITIATE

Following surgery for a hip fracture (broken hip) hospitals aim to help patients out of bed within 48 hours of surgery. Patients should also receive a minimum of 2 hours of rehabilitation per week. Patients who receive more than this seem to recover quicker and return home sooner. This study aims to find out if increasing the level of ward-based mobilisation activities for patients following hip fractures allows them to return home sooner.

Project Details:

PI: Kirsty Derrick

Start Date: August 2024

End Date: August 2025

Local Ref: 5285

DRAFT 3-CASP*

Distal Radius Acute Fracture 3: Cast verus Splint; a randomised non-inferiority trial comparing clinical and cost-effectiveness of a standard cast versus removable splint in Adults with a distal fracture tat does not require Manipulation.

When a person breaks their wrist, the treatment usually involves a support for the injured wrist. This support provides pain relief. It also protects the fracture (the break) whilst it heals.

In most hospitals in the UK, people with a broken wrist are given a plaster cast. After 4 to 6 weeks, they go back to hospital to have the cast taken off.

The results of a recent research study show that a removable wrist splint might provide the wrist with the same amount of support as a cast.

The benefit of this is that you can take it off yourself at home, so you don’t need to have it removed at a hospital. This could be more convenient for you. Providing people with a splint instead of a cast might also save money for the NHS.

At the moment, doctors, physiotherapists and other healthcare professionals are not completely sure if having a splint gives the same level of pain relief and support as a cast.

In this study, we will directly compare people receiving a cast with people receiving a splint for treating broken wrists. We want to find out if levels of pain and the ability to do everyday tasks are similar between the two groups. We will also have a look at the cost of both treatment options to the NHS, and society as a whole.

Project Details:

Principal investigators: Alasdair Bott and Fran Verey

Start date: 03/2023

End date: 12/2024

Local ref: 5350

WHiTE 10 LIT*

Lidocaine Intravenous Trial

A broken hip is a very serious injury that requires surgery to repair or replace the broken bone followed by a period of recovery in hospital. Around a quarter of patients who have a hip fracture have an episode of ‘delirium’ following surgery. Delirium is a condition where the patient loses awareness of themselves and the environment, and has difficulty thinking clearly. Inflammation, caused by the hip fracture and by the surgery to repair the hip, is thought to be the root cause of delirium. 
This study investigates the use of a drug called ‘lidocaine’ to see if it reduces the risk of delirium during surgery for a hip fracture.

Project Details:

Principal Investigator: Dr Paddy Morgan

Planned end date: June 2025

Local Ref: 5120

Rowtate*

Randomised Controlled Trial of Specialist Vocational Rehabilitation and Psychological Support to Enhance Return to Work after Trauma.

Getting back to work, voluntary work or education after an injury can be difficult. Many patients with serious injuries can have difficulties returning to work because of the physical and psychologists’ effects of problems. This can lead to financial and other problems. Overall, being in work is better for health than unemployment or prolonged sick leave. We therefore want to find out the best of healing patients make a successful return voluntary work or education. The Rowtate study aims to test the return-to-work programme support versus the standard trauma care at people returning to work after traumatic injury.

Project Details:

Principal Investigator: Edd Carlton

Planned end date: May 2025

Local Ref: 4927

ProFHER-2*

PROximal Fracture of the Humerus: Evaluation by Randomisation Trial no. 2.

This study is investigating the best way to treat patients aged 65 and over who have broken the top end of the upper arm bone (humerus) near the shoulder where the bone is broken into more than two parts.

There are currently three commonly used treatment options for fractures of this kind, which are two types of joint replacement surgery or structured non-surgical treatment. It is currently not known what the ‘best’ treatment is so this study is comparing non-surgical treatment and two types of joint replacement; ‘hemiarthroplasty’ which involves replacing only the broken ‘ball’ of the joint (top end of the arm bone), or ‘Reverse Shoulder Arthroplasty’ which replaces both the ball and socket, but replaces the ball with a socket and the socket with a ball (hence ‘reverse’).

Project Details:
Principal Investigator: Mr Mark Crowther
Planned End Date: June 2025
Local Ref: 4202

WHITE 11*

Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions (FRUITI).

Patients who sustain hip fractures that involve minimal displacement of the bone fragments may be treated surgically with either replacement of the hip joint of fixation of the fragments. The study is randomly allocating patients with these types of fracture to either type of surgery. Patients will be monitored up to 12 months post surgery.

Project Details:

Principal Investigator: Mr Tim Chesser
Planned End Date: 31/01/2029
Local Ref: 4695

UK ADAPTIS(tm)

This study aims to assess the performance and function of the newly introduced INFINITY(tm) with ADAPTIS(tm) and EVERLAST(tm) technology Total Ankle System for total ankle replacement or arthroplasty

Project Details:
Principle Investigator: Steven Hepple
Planned End Date: 31/05/2025
Local Ref: 5570

Academic Orthopaedics Studies:

PART

The clinical and cost-effectiveness of elective primary total knee replacement with PAtellar Resurfacing compared to selective patellar resurfacing. A pragmatic multicentre randomised controlled Trial with blinding.

Total knee replacement (TKR) is commonly used for treating severe arthritis, with over 100,000 performed annually in the UK. During TKR, surgeons can resurface the patella (replace the under surface of the kneecap with a plastic prosthesis) or leave the native patella to articulate with the femoral implant. Resurfacing the patella is initially more expensive (longer theatre time, higher implant cost, risk of additional post-operative complications), but in the long-term it can reduce the risk of on-going pain which can result in further surgery to resurface the patella. NICE recommends always resurfacing the patella rather than never doing so. NICE did not find sufficient evidence on selective resurfacing (intraoperative decision based on the state of the patellar surface and the patients' symptoms) to make a recommendation on that strategy, but did recommend specific research was conducted on this question. If effective, selective resurfacing could result in optimal individualised patient care. This study evaluates the clinical and cost-effectiveness of elective primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

Project Details:

Chief Investigator: Ashley Blom

Principal Investigator: Sven Putnis

Planned End Date: 31/03/2026

Local Ref: 4999

HIPPY

Hip Implant Prosthesis Programme for the Younger total hip replacement patient.

Over 100,000 hip replacements are performed each year in the UK. Around 90% of patients report good pain relief and mobility after surgery, and most implants last 25 years or more.

Primary hip replacement involves replacing a damaged hip joint with an artificial implant that has two main parts. One part goes into the leg bone and ends in a ball which fits into a socket or cup attached to the pelvis, making a ball-and-socket joint. Implants can be fixed to bone with cement (cemented), without cement (uncemented), or partially cemented (hybrid). Cost ranges from £500 for some cemented to £2,000 for some uncemented implants.

When an implant fails, for example due to loosening or wear, it has to be re-done. Revision is a major operation, typically costing the NHS over £10,000. Cemented hip implants are safe, inexpensive, have a long track-record, and offer the best value-for-money for men aged over 75 and women aged over 65 years. There is no high-quality evidence to suggest more expensive uncemented or hybrid implants are any better than cemented implants for younger patients. Yet three quarters of NHS patients aged under 70 years receive uncemented or hybrid implants.

This Programme of research aims to find out which hip implants are best for patients under 70 years of age.

Project Details:

Chief Investigator: Elsa Marques

Principal Investigator: Mike Whitehouse

Planned End Date: 01/07/2031

Local Ref: 5258, 5259

Elective Orthopaedics Studies:

UK ADAPTIS™

This study aims to assess the performance and function of the newly introduced INFINITY™ with ADAPTIS™ and EVERLAST™ technology Total Ankle System for total ankle replacement or arthroplasty in patients with severe osteoarthritis of the ankle.

Project Details:
Principal Investigator: Steven Hepple

Start Date: 02/09/24
Planned End Date: 31/05/2025
Local Ref: 5570

Furlong Evolution® Hip Trial

This is a commercial study reviewing progress of patients who have undergone total hip replacement surgery using the Furlong short stem implant. The potential benefit for using a short stem implant is that it aids early mobilisations and preserves the femoral bone should further surgery be required.

Project Details:
Principal Investigator: William Poole
Planned End Date: 30/09/2027
Local Ref: 3275

UK Multi-centre, observational, prospective, Post-Market Clinical Follow-up of the INFINITY® Total Ankle System

A commercial study involving review of patients treated with an INFINITY Total Ankle Replacement. The study is collecting clinical and patient reported outcomes up to 10 years following surgery.

Project Details:

Principal Investigator: Mr Steve Hepple
Planned End Date: 31/12/2029
Local Ref: 4168

ReMatch

This study aims to compare two different plates currently used in knee realignment surgery (high tibial osteotomy). The purpose of the metal plates is to maintain the correct realignment achieved at surgery whilst the bone heals. The two plates, TomoFix and ActivMotion are both used in current practice and comply safety regulations.

Once the knee correction has healed (approx. 12 months) the plate can be left in. Some patients may however experience discomfort that related to the plate and benefit from plate removal ,  about a year after their initial operation. The ActivMotion plate design is a smaller than the Tomofix and it is therefore potentially less likely to cause discomfort . It is anticipated that second operations for plate removal will be less frequent than for the Tomofix plate.

In this study we would like to compare the number of plates that need removal following surgery, assess pain levels in patients in the first two years following surgery and compare the amount of pain relief used in the immediate post-operative recovery period.

Participants will be asked to complete a questionnaire before they have their operation and twelve months after the operation to assess their pain and function. This information will be used to compare the outcome of the plates.

Project Details:
Principal Investigator: Mr James Murray
Planned End Date: 31/03/2024
Local Ref: 3810

PERSONA

This study is a prospective, post-market, global, multi-center, non-controlled, observational clinical evaluation of the commercially available Persona® Partial knee implant. The primary objective of the study is to obtain survivorship data and assess clinical performance (outcomes) using outcome measurement tools (e.g. patient questionnaires), radiographic assessments and adverse event data.

In total, there will be 30 global sites in the US and Europe. In the UK, the multi-centre study is being conducted at four sites in England with a maximum of 40 patients at each centre. Male and female individuals aged 18 years and over, with a confirmed diagnosis of osteoarthritis and who qualify for unicompartmental (partial) knee surgery will be potentially eligible to take part. Each Investigator will offer study participation to each consecutive eligible patient who satisfies the Inclusion/Exclusion criteria for partial knee arthroplasty using the commercially available Partial Persona Knee.

Following completion of the informed consent process, participants will undergo preoperative clinical evaluations prior to their partial knee arthroplasty. Patients will then be asked to attend post-operative follow-up clinic visits at 3 months, 1 year, 2 year, 5 year and 10 year. At these follow-up visits, clinical and radiographic evaluations will be conducted.

Project Details:

Principal Investigator: Mr Andrew Porteous
Planned End Date: 31/12/2028
Local Ref: 3905

Hip Replacement Failure & Bone Density

Hip replacements are a very common operation for people with painful arthritis. However, sometimes these hip replacements need to be done again because of pain and loosening.  We think that similar things may lead to loss of bone density (thinning of the bones) and loosening of joint replacements.  Because of this there is concern that loss of bone density may increase the need for further surgery to correct the loose joint replacement.

The study aims to see if there are differences in bone density and other factors that may explain why some people need their hip replacements done again (revised) and some do not.

Project Details:

Principal Investigator: Dr Emma Clark
Planned end date: 31/12/2025
Local Ref: 2503

RAPSODI

 Reverse or Anatomical replacement for Painful Shoulder Osteoarthritis, Differences between Interventions (RAPSODI): a multi-centre, pragmatic, parallel group, superiority randomised controlled trial. 

Patient aged 60 years or over with painful OA of the shoulder and an intact rotator cuff presenting to secondary care and through shared making, having completed non-surgical treatments, proceeding to shoulder replacement. In shoulder replacement surgery, doctors remove the damaged parts of the shoulder and replace them with plastic or metal parts. 

The RAPSODI-UK study compares two types of shoulder replacement: the Total shoulder  replacement, and the Reverse Shoulder replacement.  These are the two types of shoulder replacement that NHS doctors use most often for patients with arthritis who need a shoulder replacement.  

They both help to reduce pain, and maintain or improve movement. However, doctors genuinely don’t know yet which one works best. 

 Project Details:

Principal Investigator: Mr Mark Crowther  

Planned end date: 30/08/2024 

Local Ref: 5267 

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Telephone: 0117 4149330
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Orthopaedics
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What to eat at Christmas - information for kidney patients

Regular On Off

This is a guide to eating and drinking over Christmas if you have been asked to:

  • Eat less potassium – to help prevent a high blood potassium level.
  • Drink less fluid – to help your breathing and control fluid building up.
  • Eat less salt – to reduce thirst and help control blood pressure.

Use this information alongside the information about ‘Eating less potassium’ and ‘Managing fluid intake’ given to you by the dietitian.

What can I eat and drink during Christmas?

Here is information on some foods and drinks you can enjoy over the festive period.

It is still important to be careful with foods high in potassium and keep to your fluid allowance. 

Remember:

  • Foods included here still provide potassium, salt, and phosphate so try not to eat in large amounts.
  • Count foods such as gravy, sauces and custard within your fluid allowance. 
  • Foods such as bacon, ham, sausages, stuffing, gravy, cheese and salted snacks can make you thirsty so eat in smaller portions.
  • If you have diabetes, you can include a portion of dessert and a sweet treat such as cake or biscuits or chocolate. Try to cut back on these afterwards.
  • If you are prescribed phosphate binders, take these with meals and snacks containing phosphate.
  • If you are eating away from home over Christmas, planning ahead can help you to choose suitable foods. Ask the dietitian if you would like to discuss ideas.
  • Try to cut back on festive foods and drinks after Christmas. 

How can I include a high potassium food I like at Christmas? 

You may be able to include a high potassium food by swapping this for another food. For example:

  • If you are eating a high potassium vegetable such as parsnips with your meal, boil first and eat in place of some potatoes.
  • If you eating a small amount of nuts, eat this in place of a fruit.
  • Cutting back on coffee, fruit juice or a milky drink will help to reduce potassium and fluid in case you do eat or drink a little more of other things.
  • Speak to the dietitian for more advice on food swaps.

Low potassium Christmas cake

This recipe makes a fruit cake with a lighter sponge and all the flavours of Christmas. It doesn’t need to mature like a traditional Christmas fruit cake.

Serves 16.

Ingredients

  • 10oz/250g glace cherries, quartered
  • 10oz/250g mixed peel
  • 8 oz/200g tinned prunes, drained and chopped
  • 5 eggs
  • 2 dessert spoons of brandy/rum
  • ½ teaspoon of almond essence (optional)
  • 10oz/250g plain flour
  • 1 teaspoon baking powder
  • 7oz/175g soft brown sugar
  • 10oz/250g unsalted butter, softened
  • ½ teaspoon ground cinnamon
  • 1 teaspoon ground mixed spice

Method

  1. Place the cherries, mixed peel and prunes in a large bowl, add the brandy/rum and leave to soak overnight.
  2. Grease a 7” (18cm) round cake tin, and double line with greaseproof paper. Preheat the oven to 140oC/120oC fan assisted.
  3. Beat the butter, sugar, flour, eggs and spices in a large mixing bowl until well combined. Fold in the pre-soaked fruit and pour into the prepared cake tin.
  4. Place a double layer of greaseproof paper loosely on top of the cake, and bake in the oven for 3 ½ to 4 hours. Remove greaseproof paper 15 minutes towards the end of cooking.
  5. Leave to cool in the tin, and once cooled decorate with the icing of your choice. Store in an airtight container.

Orange & cinnamon icing for Christmas cake

Ingredients

  • 120g icing sugar
  • 1tsp ground cinnamon
  • 1tsp (5ml) water
  • 2tsp (10ml) juice of an orange

Method

Sieve the icing sugar together with 1 tsp cinnamon, and mix with the water and juice of an orange. The icing should be thick enough to coat the back of the spoon. If it is too runny add a little extra sieved icing sugar, or if it is too thick then add a little more water.

Low potassium Christmas pudding

Ingredients

  • 8oz/200g plain flour
  • 1 apple, grated
  • 1 carrot, grated
  • 4oz/100g sugar
  • 4oz/100g mixed peel
  • 3oz/75g glacé cherries
  • 4oz/100g white breadcrumbs
  • 3oz/75g tinned plums, drained and chopped
  • 4oz/100g tinned prunes, drained and chopped
  • 2 teaspoons mixed spice
  • 1 egg
  • 6 fl oz/150 ml milk
  • 2 fl oz/50 ml brandy
  • Caramel colouring
  • 2 teaspoons lemon juice

Method

  1. Mix together the flour, apple, carrot, sugar, mixed peel, cherries, breadcrumbs, plums, prunes and mixed spice.
  2. Add the milk, brandy, egg, a little caramel colouring and lemon juice. Mix well.
  3. Line a pudding bowl with a floured pudding cloth and place the mixture in the centre. Tie securely.
  4. Put into a large pan half filled with hot water and boil the pudding for 4 hours. Cool and keep in the fridge.
  5. Steam again for 4 hours before serving hot.

Christmas dinner

Meat, poultry, fish

Foods to choose from

Turkey, chicken, duck, goose, beef, lamb, pork or fish.

Vegetarian main instead of meat or fish

Foods to choose from

Dishes made with tofu, Quorn, lentils, pumpkin,or squash. Cheese or brie and cranberry pastry parcels.

Foods high in potassium

Dishes made with nuts, courgette, mushrooms, spinach, sweet potato.

Potatoes

Foods to choose from

Boil potatoes first to make roast or mashed potatoes.

Foods high in potassium

Potatoes which have not been boiled.

Vegetables

2-3 portions

1 portion = 2-3 tablespoons

Foods to choose from

Boil vegetables. Choose those lower in potassium such as carrots, red cabbage and cauliflower. Limit Brussel
sprouts to 6.

Foods high in potassium

Vegetables such as mushrooms, parsnips, spinach, vegetable/tomato soup.

Trimmings and sauces

Foods to choose from

Yorkshire pudding, apple sauce, cranberry sauce, homemade bread sauce, mint sauce and horseradish.

Desserts

Foods to choose from

Fruit pie or crumble (except for rhubarb, blackcurrant or apricot), artic roll, gateaux, ice cream, sorbet, pavlova,
profiteroles or trifle. Brandy/rum butter or double cream with puddings.

Foods high in potassium

Try to limit to 1 portion of either Christmas pudding or Christmas cake or 1 mince pie or 1 slice of Yule log.

Fruits (2 fruit portions)

Foods to choose from

Clementines, satsumas, apple, raspberries, tinned fruit.

Foods high in potassium

Fruits such as apricots, bananas, dried fruit and fruit juices.

Nibbles & snacks

Foods to choose from

Plain breadsticks, unsalted popcorn, corn, maize or wheat snacks (choose those without potassium chloride), pickled onions, cheese and biscuits. Carrot or cucumber sticks with cottage/cream cheese or sour cream or mayonnaise dips. Cranberries. Chestnuts (5)

Foods high in potassium

Potato crisps, Twiglets, guacamole, salsa, nuts and dried fruit.

Canapes

Foods to choose from

Chicken or fish goujons, mini sausages, blinis or crispbreads with pate or salmon and cream cheese, prawns, arancini balls, mini quiches or vol au vents.

Biscuits & cakes

Foods to choose from

Sponge cake, gateaux, cream cakes, jam tarts, jam or cream swiss roll, brandy snaps, gingerbread or shortbread.

Foods high in potassium

Stollen, biscuits, cake containing dried fruit, nuts.

Sweets & chocolate

Foods to choose from

Jelly sweets, mint creams, marshmallows and Turkish delight.

Foods high in potassium

Liquorice, hot chocolate. Limit chocolate to 4 pieces / squares or 2 chocolate coated biscuits.

Alcoholic drinks

Foods to choose from

Liqueurs, port, sherry, spirits. 1 small beer/lager or 1 glass of wine/mulled wine or champagne.

Foods high in potassium

Cider and strong ales. Drinks/cocktails with fruit juice.

Where can I find some recipe ideas?

The Kidney Care UK website has a range of recipes and can be found at: https://www.kidneycareuk.org/about-kidney-health/living-kidney-disease/kidney-kitchen/recipes/

These also include a selection of low potassium Christmas recipes:

  • Pear and white cheddar salad
  • Christmas Cake
  • Traditional mince pies
  • Gingerbread Christmas Log
  • Steamed Christmas pudding
  • Brie and cranberry parcels
  • Sausage Christmas tree
  • Turkey Curry
  • Chocolate profiteroles with Chantilly cream
  • Christmas pudding cheesecake
  • Christmas turkey crown with all the trimmings

Some recipes are also low phosphate or low salt. You can check this under the ‘Nutrition’ section of each recipe.

If you are unable to look at the recipes on the Kidney Care UK website and would like a printed a copy of a particular recipe, please ask your renal dietitian for this.

© North Bristol NHS Trust. This edition published June 2023. Review due June 2026. NBT003433.

Contact Nutrition & Dietetics

Kendon House
Kendon Way
Southmead Hospital
Bristol

Telephone:  0117 414 5428 or 0117 414 5429