1206657 / CRPS

To evaluate the long-term survivorship of the INFINITY® implant over 10 years (Study due to close 01/09/2021)

1310841 / Sequencing Based Genetic Analysis of Systemic Lupus Erythematosus

Sequencing Based Genetic Analysis of Systemic Lupus Erythematosus (Study due to close 04/12/2022)

1405938 / Unity Total Knee Replacement

The aim of this study is to compare the short-term functional outcomes of the Unity TKR for two different surgical techniques for knee alignment (both commonly used) and then to compare the results retrospectively with a competitor TKR system (Triathlon).  As a new TKR on the market, comparative functional outcome is important.  (Study due to close 30/09/2018)

1406940 / PREVeNT RA

BACKGROUND
Rheumatoid arthritis (RA) is the most common form of chronic inflammatory arthritis and costs the UK economy of £1.8 billion per annum. Both environmental and genetic risk factors interact to influence the development of rheumatoid arthritis. If high risk individuals can be identified in the community, the prevention of RA should be a realistic goal.

STUDY OBJECTIVES
1. To establish a national cohort of first degree-relatives (FDRs) of patients with established RA.

2. To use lifestyle, serological and genetic risk factors in a prediction algorithm to stratify FDRs according to risk.

3. To use serological and proteomic profiling, and ultrasound imaging to study the evolution of disease in those at highest risk.

4. To identify new cases of inflammatory arthritis as they occur within the cohort.

5. To study cardiovascular risk biomarkers including anthropometric measures, blood pressure and aortic pulse wave velocity in a subset of the main cohort.

METHODS & RECRUITMENT
Participants will be identified through their relatives with RA or through responses to adverts. Participants will be asked to donate a blood sample and complete a questionnaire. A subset of the participants will be invited for detailed assessment of risk biomarkers.

CONCLUSION
This “at risk” cohort will allow us to better understand the interplay between the environment, genes and the evolution of immune and inflammatory responses. PREVeNT RA will allow us to define biological signatures that can be exploited to facilitate rapid assembly of high risk individuals from the general population, for timely prevention studies. (Study due to close 31/03/2022)

1501045 / Understanding the experience and provision of surgical treatment for prosthetic joint infection: a qualitative study

Understanding the experience and provision of surgical treatment for
prosthetic joint infection: a qualitative study (Study due to close 31/05/2018)

1501048 / UK FASHIoN

The hip joint has two bones that fit together like a ball in a socket. In some people these bones press against each other and can cause pain. The medical term for this is femoroacetabular impingement (FAI for short). There is now good evidence to suggest a link between FAI and the development of premature osteoarthritis (wear and tear) of the hip. But we do not know how best to treat FAI. There has been a rapid growth around the world and in the NHS to use keyhole surgery to treat this condition. This operation is called ‘hip arthroscopy’. An alternative treatment for patients is a course of best conventional care ( a structured programme of exercised based care supervised by a physiotherapist), aimed at improving the muscle strength and control around the hip joint. There are fewer risks associated with this type of treatment and it is less expensive.

We propose a randomised controlled trial to determine which of these two treatments is most effective for treating patients with FAI up to 12 months after treatment. Patients who agree to take part will be allocated to one of the two treatments and complete follow-up questionnaires about their hip, general health, any complications and any out of pocket expenses as a result of treatment at 6 and 12 months post-study entry, a further procedural questionnaire will be completed at 2 and 3 years. We will recruit patients from 25 hospitals throughout the UK over 20 months. The aim will be to ensure that in just less than five years both patients with FAI and healthcare professionals managing FAI will know what the best treatment is. (Study due to close 01/09/2019)

1504082 / Development of a National Joint Registry DNA Biobank

Development of a National Joint Registry DNA Biobank (Study due to close 01/10/2016)

1510143 / INFORM Surgery

A multicentred randomised trial to compare 1stage with 2 stage revision surgery for prosthetic hip joint infection (Study due to close 31/08/2018)

1511168 / Apoptotic neutrophils in the peripheral blood

Is the accumulation of apoptotic neutrophils in the peripheral blood of systemic lupus erythematosus patients due to decreased levels of plasma membrane peroxidation in these cells? (Study due to close 01/08/2019)

1608287 / Rejuvenate

REJUVENATE (Does NAD+ precursor supplementation rejuvenate skeletal muscle mitochondrial function and physical capacity in ageing humans?) (Study due to close 31/10/2019)

1610323 / INFINITY®

To evaluate the long-term survivorship of the INFINITY® implant over 10 years (Study due to close 28/02/2019)

1702372 / The British Orthopaedic Surgery Surveillance Study

Clinical trials randomly allocating treatments in rare orthopaedic diseases are challenging. Perhaps the biggest challenges arise due to the infrequency of disease, and often emergent nature of treatment. Where interventions are surgical, individual surgeons are likely to develop expertise in and therefore preference for one particular technique.

Establishing clinical equipoise, a point at which clinicians are truly uncertain which is the best  treatment option and a prerequisite for a randomised trial, can be very difficult since evidence of effectiveness is usually based on case series from individual centres. Multicentre randomised controlled trials of surgical interventions can therefore be very difficult to establish.

There are many clinical management decisions in such situations which cannot be informed by randomised controlled trials, simply because this evidence does not exist. Robust, population based prospective observational studies can provide an alternative form of high quality evidence to inform policy and practice. Retrospective studies using data collected for administrative purposes, for example hospital admissions databases, cannot provide this quality of evidence, since they do not provide sufficient detail of the timing and type of management strategies used.

The British Orthopaedic Surgery Surveillance (BOSS) Study is a system through which to collect information about individuals with specific orthopaedic conditions, or undergoing specific orthopaedic procedures. BOSS uses the same methodology as a similar successful reporting mechanisms in obstetrics and gynaecology (United Kingdom Obstetric Surveillance System – UKOSS). BOSS will study the risk factors, diagnostic methods and treatments and relate these to outcomes of Perthes’ Disease and Slipped Capital Femoral Epiphysis (though we hope to extend the diseases studied in time) on a national basis in order to make recommendations for best practice to improve outcomes.

The research will be conducted at the University of Liverpool and is funded as part of a Clinician  Scientist Award. (Study due to close 30/06/2019)

1702379 / The STAR trial

The STAR trial: Evaluation of a care pathway for patients with long-term pain after knee replacement.  Our proposed study will run a trial of a new, best care pathway to see if it is of benefit to patients with long-term pain after knee replacement. We will recruit 380 patients with pain at 3 months after knee replacement from four hospitals in the UK. Two-thirds of patients will be randomly chosen to receive the STAR care pathway and one-third of patients will receive the usual care that their hospital provides. The STAR pathway involves a clinic appointment with a healthcare professional to better understand the possible causes of pain after knee replacement.

People will then be referred to see relevant health professionals for treatment as needed, such as physiotherapists, orthopaedic surgeons, GPs, or pain specialists. We may decide that for some people the most appropriate course of action is to regularly monitor their pain, and then begin treatment if the pain worsens. We will ask everyone in the study to complete questionnaires after 6 months and 12 months to see if the STAR care pathway improves patients’ pain. We will also collect information to compare the cost of providing both treatments. The findings from this study will help us to know if providing the STAR care pathway can improve patients’ outcomes after knee replacement and is good value for money to invest NHS resources. (Study due to close 01/03/2020)

1703399 / Osteoarthritis Thumb Therapy trial

Symptomatic thumb base OA affects 20% of the population over 55 years, causing more pain, work disability, reduced
quality of life and function than OA elsewhere in the hand. International experts recommend splinting for hand OA but
there is limited evidence from robust trials to support this.

OTTER II is a multicentre, single blind, randomised controlled clinical effectiveness and efficacy trial. Occupational  therapy and physiotherapy centres in England will recruit participants aged 30 years and over with clinical thumb base OA. People with  symptomatic thumb base OA and moderate to severe thumb base pain will be allocated to either 8 weeks of self-management; 8 weeks of self-management plus a verum splint, or 8 weeks of self-management plus a sham splint. Follow up will be for 12 weeks from baseline.The primary outcome is the AUSCAN hand pain scale. The study end point is 8 weeks. Outcomes will be collected at baseline; 4 weeks; 8 weeks; and 12 weeks. Findings will improve the management of thumb base OA and add to understanding contextual aspects of rehabilitation and self management strategies for OA.

The study design builds on experience of conducting the OTTER pilot study and the practical implications for supporting clinicians across the UK to recruit into and deliver a fully powered randomised control effectiveness and efficacy trial. This design is a straightforward pragmatic design that will be able to be supported by NHS out-patient
clinics and associated booking procedures throughout the NHS.

The study has been informed by patients and the public and is designed according to the recommendations for the conduct of randomised controlled trials of osteoarthritis [63, 64].  (Study due to close 31/08/2018)

1705419 / Mixed methods evaluation of the Getting it Right First Time programme

The Getting it Right First Time project (GIRFT) aims to deliver improvements in quality and reductions in the cost of NHS orthopaedic care across England. It involves three core strategies: (1) feedback of performance data to hospitals; (2) tailored written feedback to underperforming hospitals; and (3) changes to the way hospitals are paid, to encourage improvement. The GIRFT approach will in due course be rolled out across nine other NHS surgical specialities.

We will evaluate the planned changes to orthopaedics to identify lessons to inform future efforts to improve the organisation and delivery of services. We will study documents relating to the changes and interview a wide range of stakeholders (hospital staff, commissioners, and national project team) about how the changes were implemented and what impact they have had. We will analyse performance and cost data before, during and after the changes to assess whether the GIRFT programme has a) reduced variations in both the cost of care and the way it is delivered and b) improved patient outcome measures. We will also conduct focus groups with patients and members of the public to explore their perceptions of the planned improvements to care.

Evaluation will enable us to understand better what works, at what cost, but also to study how changes of this kind are implemented and sustained. We will provide feedback to change leaders and decision-makers, locally and nationally, as well as identifying lessons to inform future efforts to improve care. We will produce ‘lay’ versions of our reports for patients and the public, as well as management briefings for NHS policy makers, managers and clinical leaders. We will also disseminate findings through academic and professional journals, and presentations at conferences. (Study due to close 31/12/2018)

1705432 / Prevalence of Inflammatory Back Pain in Young Adults & Subsequent Longitudinal Inception Cohort Study

Back pain is one of the commonest reasons why patients visit their General Practitioner; one third people in the UK will suffer an episode of back pain each year, and 20% of those patients will consult their GP for help.  Back pain represents the second commonest cause of sickness absence from work in the UK and is one of the costliest problems faced by the NHS. (Study due to close 31/03/2020)

1709493 / A Randomised Controlled Trial of the effect of a Two-layer Compression Bandage System on Knee Function following total knee arthroplasty

The use of compression bandages in elective orthopaedic knee surgery is well regarded, however, there is a lack of robust, well-designed trials to support this.

The aim is to conduct a randomised controlled trial comparing the use of a two-layer compression bandage worn post-operatively for up to 48 hours after elective total knee replacement, compared to standard practice (non-compressive bandaging).

The study aims to test the hypothesis that the use of a two-layer Compression Bandage System improves function compared to standard wool and crepe bandage, following total knee replacement.

Patients will be approached to take part from participating hospitals and those who agree to be included in this trial will be allocated at random to either of the two treatments.

Outcome will be assessed using a patient self-reported questionnaire which measures knee pain and function after one year.

The associated costs of both treatments to the NHS will also be evaluated. (Study due to close 31/08/2018)

1711519 / BILAG Biologics Prospective Cohort

The BILAG Biologics Prospective Cohort is a prospective observational cohort study of patients with SLE who are starting treatment with a biologic drug or a conventional, non-biologic therapy. The study aims to recruit 220 patients into the biologic treatment group and a further 220 patients into the conventional, non-biologic therapy cohort.

The aim of the BILAG BR is to ascertain whether using biologics in the routine treatment of SLE is associated with an increased risk of hospitalisation for infection, compared to SLE patients with similar disease activity receiving conventional therapies. The secondary purpose of the BILAG Biologics Prospective Cohort is to determine the long-term efficacy of biological therapies in the treatment of SLE.

This prospective cohort study will recruit an exposed cohort of patients with SLE treated with biological therapies and an unexposed cohort of patients with similar disease characteristics but exposed only to conventional non-biological therapies. Comprehensive data will be collected at baseline, from the clinic team and the patient, including data on disease diagnosis and activity, risk factors for infection and routine laboratory results. Follow-up data will be collected at 3, 6, 12, 24 and 36 months to include any changes in medications, adverse events, hospitalisations for infections, disease activity and quality of life along with biological samples for biomarker analysis. (Study due to close 01/12/2018)

1711525 / Proposal for A Prospective, Randomised Internal Pilot Study Investigating the Use of Metaphyseal Cones versus a Cemented Stem Construct in Revision Total Knee Replacement in Patients with AORI Grade 2 Defects- a Comparison of Clinical, Functional and Radiological Outcome.

In time, some total knee replacements (TKR) will fail-usually either because of wear or loosening of the replacement parts. Further, more complex surgery may be needed- revision TKR. When the old TKR is removed, a large cavity can be left in the bone. The new TKR has to be placed into this. The cavity has to be somehow either filled in or bypassed to ensure the new TKR is secure enough for early weight-bearing and long term survival.

It may be possible to simply cement another TKR into the cavity -using short or long stemmed components. Alternatively, a device called a “cone” is placed into the bony cavity and a new TKR- with short or long stemmed components- can be cemented into this. Bone grows onto the cone to ensure its stability. All of these types of revision TKR are presently in use – no-one knows which type is best.

We are trying to establish which type of revision TKR is best for patients. However, we need to do a pilot study as a rehearsal of all the procedures and logistics that will be undertaken in what is planned to be a full randomised study. We will look at questionnaires to measure how well the patients feel their knee is performing, specific tests to measure knee function, and use x-rays and scans to analyse the performance of the new TKR. The pilot study results will allow us to assess practical matters such recruitment and data collection issues and to calculate the sample size and study power for the substantive study.

Patients who meet the inclusion criteria and consent to be in the study will be randomly allocated to receive one of the revision TKR options as outlined above and their progress monitored for 5 years after the operation. (Study due to close 30/06/2019)

1711530 / ATM

Achilles Tendinopathy Management: A placebo controlled randomised trial evaluating platelet rich plasma injections (Study due to close 31/12/2020)

1711539 / Adjustable or fixed loops in ACL surgery

Adjustable or fixed loops in ACL surgery (Study due to close 31/03/2020)

1802588 / A prospective, randomised, controlled study of the outcomes and cost effectiveness of Triathlon CR knee replacement system:  traditional instruments versus alternative alignment technique.

As many as 20% of patients are unhappy with the results of total knee replacement (TKR). Various changes to surgical technique have tried to address this but have not led to a significant improvement in the numbers of patients satisfied with their operation.
Recently, attention has focussed on alignment of the leg. When viewed from the front, a number of people do not start with a straight, mechanically aligned leg.

Traditionally, when implanting a knee replacement, the surgeon tries to put the shin bone half of the knee replacement perpendicular to the floor to equalise stresses on the in and outside of the joint. However, this may result in the alignment of the leg changing considerably, straining the soft tissues around the knee and contributing to dissatisfaction with TKR.

There has been a move by some surgeons to change practice, and to implant the TKR in a way that replicates the alignment of the patient’s own original knee- alternative alignment. Studies looking at alternative alignment have not shown any loss of satisfaction with results of TKR and indeed are showing some signs that in the short term, function of the knee may be better with the new technique.

We are planning to run a study comparing the knee replacement we use in Exeter- the Triathlon- when put in place using traditional alignment methods versus using the alternative alignment technique. We will assess the results in various ways including patient satisfaction questionnaires, measuring muscle strength, flexibility around the knee, and by assessments of alignment of the new knee on X-rays and CT scans. We will look at short term results for satisfaction and function of the knee, and in the long term look at wear and survivorship to see if we can improve patient satisfaction with TKR. (Study due to close 31/12/2019)

1802591 / A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects with Active Sjogren’s Syndrome

Sjogren’s Syndrome (SjS) is a disease where a person’s own immune system attacks parts of the body such as the joints, the skin and the glands that make tears for the eyes or saliva for the mouth. It is estimated to affect approximately 1% of the population worldwide. Therapeutic options for Sjogren’s syndrome are few. There is an unmet need for safe therapies that can effectively improve the disease course.
This is a randomised, double-blind, placebo-controlled study sponsored by Gilead Sciences, Inc. The purpose of this study is to see how safe and effective filgotinib, GS-9876 and GS-4059 are at treating Sjogren’s Syndrome.

Approximately 140 participants (male and female) from 70 study centres in 8 countries, in North America and Europe will take part.   Participation will last about 52 weeks, not including the screening visit.   During this time, participants will be required to visit the clinic at least 14 times.

Participants will be randomly assigned (like tossing a coin) to the medicine. They will have 1 out of 4 chance (25%) to receive filgotinib, 1 out of 4 chance (25%) to receive GS-9876, 1 out of 4 chance (25%) to receive GS-4059, and 1 out of 4 chance (25%) to receive placebo (dummy drug).

Study procedures include: Review your health history and Sjogren’s Syndrome   history, Complete physical examination (including weight and height), physical exam, vital signs   (blood pressure, heart rate, breathing rate, body temperature), blood, urine and saliva samples, examinations, ECG (recording or the heart), breathing tests, dry mouth test, eye exams, ultrasound, CT scan, administration of study medicine. (Study due to close 01/12/2018)

1804575 / A multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.

INSTEP – INSoles To Ease Pressure . A multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.

One of the common problems associated with diabetes is the development of foot ulcers. These are frequently associated with high pressure areas and loss of feeling in the feet.

Insoles and specialist shoes are often provided to move the pressure from the high impact areas to other parts of the foot to try and either heal the ulcer or reduce the risk of ulcers occurring. Unfortunately there are frequent delays in providing the insoles and shoes and no way of testing how efficient they are in moving the pressure around the foot.

Therefore the National Institute of Health Research have funded this study to compare 2 groups of 38 people with diabetes and sensory neuropathy that have been categorised as high risk of developing a foot ulcer from Torbay, Exeter and the Solent areas. One group will be given special insoles made using new technology (a sensor that fits inside the patient’s shoe measuring the walking pressures under the foot) and the other will be given plain cushioned insoles. We will determine whether there is any difference in reducing the harmful pressure points and stopping ulcers forming between the groups over a 12 month period. We also want to interview 12 of the participants and the three clinicians taking part about their experiences of being in the trial.

Once we have collected all of the data we intend to run a large scale trial over many areas around the country to test this new idea. Ultimately we hope to reduce the risk of people with diabetes developing foot ulcers. (Study due to close 11/12/2019)

1805631 / UK Safe

Towards UK post Arthroplasty Follow-up rEcommendations: UK Safe (Study due to close 31/08/2018)

1807652 / Analysis of specimens from patients with painful metal on metal hip replacements

Analysis of specimens from patients with painful metal on metal hip replacements (Study due to close 30/04/2019)

1811712 / ASCRIBED

Research suggests that acute illnesses or injury causing inflammation can accelerate dementia. However there are few studies which examine underlying mechanisms of how this happens in humans. We aim to address this gap. We will compare markers of inflammation and injury found in the blood and cerebrospinal fluid (CSF) of people with and without confirmed dementia who fracture their fracture. A hip fracture is a common example of an acute injury causing an inflammatory response.

People who fracture their hip will undergo an operation to repair it. A common procedure during this operation is the giving of spinal aesthetic. This involves inserting a needle into the patient’s spinal space and injecting anaesthesia into the fluid which bathes the spinal cord (i.e. the CSF). This means CSF can be collected before operation via the same needle.

We will approach and recruit patients due to have a hip fracture operation via spinal anaesthesia with all levels of pre-operative confusion. Patients will be allocated post-operatively to one of three groups; A) confirmed dementia (as obtained from patient’s GP notes/hospital records and/or carer insight); B) non-dementia (no evidence of dementia found in patent’s GP notes/medical records) groupings; C) pre-operatively confused but without confirmed dementia. We aim to recruit 400 patient in total.

Consent will be gained for the storage of surplus samples in a bio-bank to help future studies. Pre-operative blood and CSF samples, post-operative blood samples and a short cognitive questionnaire will be administered to all patients. We will also obtain blood samples and data on memory and thinking at 1, 3 and 6 months from a subgroup of patients. This will allow us to look at the effect of the injury on cognitive decline over this period. (Study due to close 15/03/2019)