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1.  Has Metal-On-Metal Resurfacing Been a Cost-Effective Intervention for Health Care Providers?—A Registry Based Study 
PLoS ONE  2016;11(11):e0165021.
Background
Total hip replacement for end stage arthritis of the hip is currently the most common elective surgical procedure. In 2007 about 7.5% of UK implants were metal-on-metal joint resurfacing (MoM RS) procedures. Due to poor revision performance and concerns about metal debris, the use of RS had declined by 2012 to about a 1% share of UK hip procedures. This study estimated the lifetime cost-effectiveness of metal-on-metal resurfacing (RS) procedures versus commonly employed total hip replacement (THR) methods.
Methodology/Principal Findings
We performed a cost-utility analysis using a well-established multi-state semi-Markov model from an NHS and personal and social services perspective. We used individual patient data (IPD) from the National Joint Registry (NJR) for England and Wales on RS and THR surgery for osteoarthritis recorded from April 2003 to December 2012. We used flexible parametric modelling of NJR RS data to guide identification of patient subgroups and RS devices which delivered revision rates within the NICE 5% revision rate benchmark at 10 years. RS procedures overall have an estimated revision rate of 13% at 10 years, compared to <4% for most THR devices. New NICE guidance now recommends a revision rate benchmark of <5% at 10 years. 60% of RS implants in men and 2% in women were predicted to be within the revision benchmark. RS devices satisfying the 5% benchmark were unlikely to be cost-effective compared to THR at a standard UK willingness to pay of £20,000 per quality-adjusted life-year. However, the probability of cost effectiveness was sensitive to small changes in the costs of devices or in quality of life or revision rate estimates.
Conclusion/Significance
Our results imply that in most cases RS has not been a cost-effective resource and should probably not be adopted by decision makers concerned with the cost effectiveness of hip replacement, or by patients concerned about the likelihood of revision, regardless of patient age or gender.
doi:10.1371/journal.pone.0165021
PMCID: PMC5089767  PMID: 27802289
2.  World Hip Trauma Evaluation (WHiTE): framework for embedded comprehensive cohort studies 
BMJ Open  2016;6(10):e011679.
Introduction
Osteoporotic hip fractures present a significant global challenge to patients, clinicians and healthcare systems. It is estimated that hip fracture accounts for 1.4% of total social and healthcare costs in the established market economies.
Methods and analysis
The World Hip Trauma Evaluation (WHiTE) was set up to measure outcome in a comprehensive cohort of UK patients with hip fracture. All patients in the cohort are treated under a single comprehensive treatment pathway. A core outcome set, including health-related quality of life, is collected on all the patients. This protocol describes the current multicentre project that will be used as a vehicle to deliver a series of embedded observational studies.
Ethics and dissemination
Research Ethics Committee approval was granted (Rec reference 11/LO/0927, approved 18/8/2011) and each hospital trust provided National Health Service (NHS) approvals.
Trial registration number
The study is registered with National Institute of Health Research Portfolio (UKCRN ID 12351) and the ISRCTN registry (ISRCTN63982700).
doi:10.1136/bmjopen-2016-011679
PMCID: PMC5093367  PMID: 27797994
ORTHOPAEDIC & TRAUMA SURGERY; TRAUMA MANAGEMENT
3.  Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) protocol: a pragmatic multi-centre randomised controlled trial of cast treatment versus surgical fixation for the treatment of bi-cortical, minimally displaced fractures of the scaphoid waist in adults 
Background
A scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset.
Methods/Design
We will conduct a randomised controlled trial (RCT) of 438 adult patients with a “clear” and “bicortical” scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment.
Discussion
Scaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults.
Trial registration
The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN67901257). Date registration assigned was 13/02/2013.
doi:10.1186/s12891-016-1107-7
PMCID: PMC4893284  PMID: 27260639
Scaphoid fracture; Screw fixation; Plaster cast; Union; Randomised controlled trial
4.  Inequalities in use of total hip arthroplasty for hip fracture: population based study 
The BMJ  2016;353:i2021.
Objectives To determine whether the use of total hip arthroplasty (THA) among individuals with a displaced intracapsular fracture of the femoral neck is based on national guidelines or if there are systematic inequalities.
Design Observational cohort study using the National Hip Fracture Database (NHFD).
Setting All hospitals that treat adults with hip fractures in England, Wales, and Northern Ireland.
Participants Patients within the national database (all aged ≥60) who received operative treatment for a non-pathological displaced intracapsular hip fracture from 1 July 2011 to 31 April 2015.
Main outcome measures Provision of THA to patients considered eligible under criteria published by the National Institute for Health and Care Excellence (NICE).
Results 114 119 patients with hip fracture were included, 11 683 (10.2%) of whom underwent THA. Of those who satisfied the NICE criteria, 32% (6780)received a THA. Of patients who underwent THA, 42% (4903) did not satisfy the NICE criteria. A recursive partitioning algorithm found that the NICE eligibility criteria did not optimally explain which patients underwent THA. A model with superior explanatory power drew distinctions that are not supported by NICE, which were an age cut off at 76 and a different ambulation cut off. Among patients who satisfied the NICE eligibility, the use of THA was less likely with higher age (odds ratio 0.88, 95% confidence interval 0.87 to 0.88), worsening abbreviated mental test scores (0.49 (0.41 to 0.58) for normal cognition v borderline cognitive impairment)), worsening American Society of Anesthesiologists score (0.74, 0.66 to 0.84), male sex (0.85, 0.77 to 0.93), worsening ambulatory status (0.32, 0.28 to 0.35 for walking with a stick v independent ambulation), and fifths of worsening socioeconomic area deprivation (0.76 (0.66 to 0.88) for least v most deprived fifth). Patients receiving treatment during the working week were more likely to receive THA than at the weekend (0.90, 0.83 to 0.98).
Conclusions There are wide disparities in the use of THA among individuals with hip fractures, and compliance with NICE guidance is poor. Patients with higher levels of socioeconomic deprivation and those who require surgery at the weekend were less likely to receive THA. Inconsistent compliance with NICE recommendations means that the optimal treatment for older adults with hip fractures can depend on where and when they present to hospital.
doi:10.1136/bmj.i2021
PMCID: PMC4849171  PMID: 27122469
5.  Hospital case volume and outcomes for proximal femoral fractures in the USA: an observational study 
BMJ Open  2016;6(4):e010743.
Objective
To explore whether older adults with isolated hip fractures benefit from treatment in high-volume hospitals.
Design
Population-based observational study.
Setting
All acute hospitals in California, USA.
Participants
All individuals aged ≥65 that underwent an operation for an isolated hip fracture in California between 2007 and 2011. Patients transferred between hospitals were excluded.
Primary and secondary outcomes
Quality indicators (time to surgery) and patient outcomes (length of stay, in-hospital mortality, unplanned 30-day readmission, and selected complications).
Results
91 401 individuals satisfied the inclusion criteria. Time to operation and length of stay were significantly prolonged in low-volume hospitals, by 1.96 (95% CI 1.20 to 2.73) and 0.70 (0.38 to 1.03) days, respectively. However, there were no differences in clinical outcomes, including in-hospital mortality, 30-day re-admission, and rates of pneumonia, pressure ulcers, and venous thromboembolism.
Conclusions
These data suggest that there is no patient safety imperative to limit hip fracture care to high-volume hospitals.
doi:10.1136/bmjopen-2015-010743
PMCID: PMC4838676  PMID: 27056592
minimum volume standards; volume-outcome; hip fracture
6.  Measurement properties of the Disability Rating Index in patients undergoing hip replacement 
Rheumatology (Oxford, England)  2014;54(1):64-71.
Objective. The aim of this study was to establish and validate the measurement properties of the Disability Rating Index (DRI) in a population of adults undergoing hip replacement.
Methods. One hundred and twenty-six adults participating in a randomized controlled trial completed the Oxford Hip Score, Harris Hip Score, DRI and EuroQol Group–Five Dimensions (EQ-5D) questionnaires at four time points. The structural validity of the DRI was assessed using principal component analysis. Cronbach’s α was used to determine the internal consistency and scale reliability was also assessed. Correlation between the DRI and the other functional and health-related quality of life scales was used to check criterion validity. DRI responsiveness was estimated and the interpretability of the scale was also assessed by checking for edge effects.
Results. Results of analyses showed that the DRI was internally consistent (Cronbach’s α = 0.92), had good association with both function-specific and general health-related quality of life scores and was sensitive to change (smallest detectable change = 2.7). No evidence of edge effects was found. Furthermore, structural assessment of the DRI revealed two novel subscales representing simple tasks and difficult tasks.
Conclusions. The DRI is structurally valid, responsive and concurs with functional assessment in adults undergoing hip replacement.
doi:10.1093/rheumatology/keu293
PMCID: PMC4269794  PMID: 25065007
disability evaluation; patient reported outcomes; validity; DRI
7.  Protocol for a randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb: UK Wound management of Open Lower Limb Fractures (UK WOLFF) 
BMJ Open  2015;5(9):e009087.
Introduction
Patients who sustain open lower limb fractures have reported infection risks as high as 27%. The type of dressing applied after initial debridement could potentially affect this risk. In this trial, standard dressings will be compared with a new emerging treatment, negative pressure wound therapy, for patients with open lower limb fractures.
Methods and analysis
All adult patients presenting with an open lower limb fracture, with a Gustilo and Anderson (G&A) grade 2/3, will be considered for inclusion. 460 consented patients will provide 90% power to detect a difference of eight points in the Disability Rating Index (DRI) score at 12 months, at the 5% level. A randomisation sequence, stratified by trial centre and G&A grade, will be produced and administered by a secure web-based service. A qualitative substudy will assess patients’ experience of giving consent for the trial, and acceptability of trial procedures to patients and staff. Patients will have clinical follow-up in a fracture clinic up to a minimum of 12 months as per standard National Health Service (NHS) practice. Functional and quality of life outcome data will be collected using the DRI, SF12 and EQ-5D questionnaires at 3, 6, 9 and 12 months postoperatively. In addition, information will be requested with regards to resource use and any late complications or surgical interventions related to their injury. The main analysis will investigate differences in the DRI score at 1 year after injury, between the two treatment groups on an intention-to-treat basis. Tests will be two sided and considered to provide evidence for a significant difference if p values are less than 0.05.
Ethics and dissemination
Ethical approval was given by NRES Committee West Midlands—Coventry & Warwickshire on 6/2/2012 (ref: 12/WM/0001). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences.
Trial registration number
ISRCTN33756652.
doi:10.1136/bmjopen-2015-009087
PMCID: PMC4593163  PMID: 26395498
ACCIDENT & EMERGENCY MEDICINE; WOUND MANAGEMENT; ORTHOPAEDIC & TRAUMA SURGERY
8.  UK Fixation of Distal Tibia Fractures (UK FixDT): protocol for a randomised controlled trial of ‘locking’ plate fixation versus intramedullary nail fixation in the treatment of adult patients with a displaced fracture of the distal tibia 
BMJ Open  2015;5(9):e009162.
Introduction
The treatment of displaced, extra-articular fractures of the distal tibia remains controversial. These injuries are difficult to manage due to limited soft tissue cover, poor vascularity of the area and proximity to the ankle joint. Surgical treatment options are expanding and include locked intramedullary nails, plate and screw fixation and external fixator systems. The nail and plate options are most commonly used in the UK, but controversy exists over which treatment is most clinically and cost-effective. In this multicentre randomised controlled trial we aim to assess ratings of disability 6 months postinjury in patients who have sustained a distal tibia fracture treated with either an intramedullary nail or plate and locking screw fixation.
Methods and analysis
Adult patients presenting at trial centres with an acute fracture of the distal tibia will be considered for inclusion. A total of 320 patients will provide 90% power to detect a difference of 8 points in Disability Rating Index (DRI) score at 6 months at the 5% level. The randomisation sequence is stratified by trial centre and age, and administered via web-based service with 1:1 treatment allocation. Baseline demographic and pre-injury functional data and radiographs will be collected using the DRI, Olerud and Molander, and EuroQol EQ-5D questionnaire. Clinical assessment, early complications and radiographs will be recorded at 6–8 weeks. Functional outcome, health-related quality of life and resource use will be collected at 3, 6 and 12 months postoperatively. The main analysis will investigate differences in DRI 6 months postsurgery, between the two treatment groups, on an intention-to-treat basis. Tests will be two-sided and considered to provide evidence for a significant difference if p values are <0.05.
Ethics and dissemination
NRES Committee West-Midlands, 6/11/2012 (ref:12/WM/0340). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences.
Trial registration number
ISRCTN99771224.
doi:10.1136/bmjopen-2015-009162
PMCID: PMC4577877  PMID: 26384729
ACCIDENT & EMERGENCY MEDICINE; HEALTH ECONOMICS; ORTHOPAEDIC & TRAUMA SURGERY
9.  Biomarkers of early stage osteoarthritis, rheumatoid arthritis and musculoskeletal health 
Scientific Reports  2015;5:9259.
There is currently no biochemical test for detection of early-stage osteoarthritis (eOA). Tests for early-stage rheumatoid arthritis (eRA) such as rheumatoid factor (RF) and anti–cyclic citrullinated peptide (CCP) antibodies require refinement to improve clinical utility. We developed robust mass spectrometric methods to quantify citrullinated protein (CP) and free hydroxyproline in body fluids. We detected CP in the plasma of healthy subjects and surprisingly found that CP was increased in both patients with eOA and eRA whereas anti–CCP antibodies were predominantly present in eRA. A 4-class diagnostic algorithm combining plasma/serum CP, anti-CCP antibody and hydroxyproline applied to a cohort gave specific and sensitive detection and discrimination of eOA, eRA, other non-RA inflammatory joint diseases and good skeletal health. This provides a first-in-class plasma/serum-based biochemical assay for diagnosis and type discrimination of early-stage arthritis to facilitate improved treatment and patient outcomes, exploiting citrullinated protein and related differential autoimmunity.
doi:10.1038/srep09259
PMCID: PMC4365413  PMID: 25788417
10.  Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial 
The BMJ  2014;349:g4807.
Objectives To compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius.
Design A multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation.
Setting 18 trauma centres in the United Kingdom.
Participants 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction.
Interventions Kirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws.
Main outcome measures Primary outcome measure: validated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient’s experience of pain and disability to give a score out of 100. Secondary outcomes: disabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery.
Results The baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was −1.3, 95% confidence interval −4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group.
Conclusions Contrary to the existing literature, and against the rapidly increasing use of locking plate fixation, this trial found no difference in functional outcome in patients with dorsally displaced fractures of the distal radius treated with Kirschner wires or volar locking plates. Kirschner wire fixation, however, is cheaper and quicker to perform.
Trial registration Current Controlled Trials ISCRTN 31379280. UKCRN 8956.
doi:10.1136/bmj.g4807
PMCID: PMC4122170  PMID: 25096595
11.  A series of decision-theoretic phase II trials of related treatments 
Trials  2013;14(Suppl 1):O8.
doi:10.1186/1745-6215-14-S1-O8
PMCID: PMC3981629
12.  Cost-effectiveness of total hip arthroplasty versus resurfacing arthroplasty: economic evaluation alongside a clinical trial 
BMJ Open  2012;2(5):e001162.
Objective
To report on the relative cost-effectiveness of total hip arthroplasty and resurfacing arthroplasty (replacement of articular surface of femoral head only) in patients with severe arthritis suitable for hip joint resurfacing arthroplasty.
Design
Cost-effectiveness analysis on an intention-to-treat basis of a single-centre, single-blind randomised controlled trial of 126 adult patients within 12 months of treatment. Missing data were imputed using multiple imputations with differences in baseline quality of life and gender adjusted using regression techniques.
Setting
A large teaching hospital trust in the UK.
Participants
A total of 126 adult patients with severe arthritis of the hip joint suitable for a resurfacing arthroplasty of the hip.
Results
Data were received for 126 patients, 4 of whom did not provide any resource use data. For the remainder, data were imputed for costs or quality of life in at least one time point (baseline, 3, 6 months and 1 year) for 18 patients. Patients in the resurfacing arm had higher quality of life at 12 months (0.795 vs 0.727) and received 0.032 more QALYs within the first 12 months postoperation. At an additional cost of £564, resurfacing arthroplasty offers benefits at £17 451 per QALY within the first 12 months of treatment. When covariates are considered, the health economic case is stronger in men than in women.
Conclusions
Resurfacing arthroplasty appears to offer very short-term efficiency benefits over total hip arthroplasty within a selected patient group. The short-term follow-up in this trial should be noted, particularly in light of the concerns raised regarding adverse reactions to metal debris from metal-on-metal bearing surfaces in the longer term. Longer-term follow-up of resurfacing arthroplasty patients and decision analytic modelling is also advised.
Trial registration
Current controlled Trials ISRCTN33354155. UKCRN 4093.
doi:10.1136/bmjopen-2012-001162
PMCID: PMC3488749  PMID: 23065450
Orthopaedic & trauma surgery < SURGERY
13.  An evaluation of the quality of statistical design and analysis of published medical research: results from a systematic survey of general orthopaedic journals 
Background
The application of statistics in reported research in trauma and orthopaedic surgery has become ever more important and complex. Despite the extensive use of statistical analysis, it is still a subject which is often not conceptually well understood, resulting in clear methodological flaws and inadequate reporting in many papers.
Methods
A detailed statistical survey sampled 100 representative orthopaedic papers using a validated questionnaire that assessed the quality of the trial design and statistical analysis methods.
Results
The survey found evidence of failings in study design, statistical methodology and presentation of the results. Overall, in 17% (95% confidence interval; 10–26%) of the studies investigated the conclusions were not clearly justified by the results, in 39% (30–49%) of studies a different analysis should have been undertaken and in 17% (10–26%) a different analysis could have made a difference to the overall conclusions.
Conclusion
It is only by an improved dialogue between statistician, clinician, reviewer and journal editor that the failings in design methodology and analysis highlighted by this survey can be addressed.
doi:10.1186/1471-2288-12-60
PMCID: PMC3476984  PMID: 22533688
14.  Total hip arthroplasty versus resurfacing arthroplasty in the treatment of patients with arthritis of the hip joint: single centre, parallel group, assessor blinded, randomised controlled trial 
The BMJ  2012;344:e2147.
Objectives To compare the clinical and cost effectiveness of total hip arthroplasty with resurfacing arthroplasty in patients with severe arthritis of the hip.
Design Single centre, two arm, parallel group, assessor blinded, randomised controlled trial with 1:1 treatment allocation.
Setting One large teaching hospital in the United Kingdom.
Participants 126 patients older than 18 years with severe arthritis of the hip joint, suitable for resurfacing arthroplasty of the hip. Patients were excluded if they were considered to be unable to adhere to trial procedures or complete questionnaires.
Interventions Total hip arthroplasty (replacement of entire femoral head and neck); hip resurfacing arthroplasty (replacement of the articular surface of femoral head only, femoral neck remains intact). Both procedures replaced the articular surface of the acetabulum.
Main outcome measures Hip function at 12 months after surgery, assessed using the Oxford hip score and Harris hip score. Secondary outcomes were quality of life, disability rating, physical activity level, complications, and cost effectiveness.
Results 60 patients were randomly assigned to hip resurfacing arthroplasty and 66 to total hip arthroplasty. Intention to treat analysis showed no evidence for a difference in hip function between treatment groups at 12 months (t test, P=0.242 and P=0.070 for Oxford hip score and Harris hip score, respectively); 95% of follow-up data was available for analysis. Mean Oxford hip score was 40.4 (95% confidence interval 37.9 to 42.9) in the resurfacing group and 38.2 (35.3 to 41.0) in the total arthroplasty group (estimated treatment effect size 2.23 (−1.52 to 5.98)). Mean Harris hip score was 88.4 (84.4 to 92.4) in the resurfacing group and 82.3 (77.2 to 87.5) in the total arthroplasty group (6.04 (−0.51 to 12.58)). Although we saw no evidence of a difference, we cannot definitively exclude clinically meaningful differences in hip function in the short term. Overall complication rates did not differ between treatment groups (P=0.291). However, we saw more wound complications in the total arthroplasty group (P=0.056) and more thromboembolic events in the resurfacing group (P=0.049).
Conclusions No evidence of a difference in hip function was seen in patients with severe arthritis of the hip, one year after receiving a total hip arthroplasty versus resurfacing arthroplasty. The long term effects of these interventions remain uncertain.
Trial registration Current Controlled Trials ISRCTN33354155, UKCRN 4093.
doi:10.1136/bmj.e2147
PMCID: PMC3330050  PMID: 22517930
15.  The Achilles tendon total rupture score: a study of responsiveness, internal consistency and convergent validity on patients with acute Achilles tendon ruptures 
Background
The Achilles tendon Total Rupture Score was developed by a research group in 2007 in response to the need for a patient reported outcome measure for this patient population. Beyond this original development paper, no further validation studies have been published.
Consequently the purpose of this study was to evaluate internal consistency, convergent validity and responsiveness of this newly developed patient reported outcome measure within patients who have sustained an isolated acute Achilles tendon rupture.
Methods
Sixty-four eligible patients with an acute rupture of their Achilles tendon completed the Achilles tendon Total Rupture Score alongside two further patient reported outcome measures (Disability Rating Index and EQ 5D). These were completed at baseline, six weeks, three months, six months and nine months post injury. The Achilles tendon Total Rupture Score was evaluated for internal consistency, using Cronbach's alpha, convergent validity, through correlation analysis and responsiveness, by analysing floor and ceiling effects and calculating its relative efficiency in comparison to the Disability Rating Index and EQ 5D scores.
Results
The Achilles tendon Total Rupture Score demonstrated high internal consistency (Cronbachs alpha > 0.8) and correlated significantly (p < 0.001) with the Disability Rating Index at five time points (pre-injury, six weeks, three, six and nine months) with correlation coefficients between -0.5 and -0.9. However, the confidence intervals were wide. Furthermore, the ability of the new score to detect clinically important changes over time (responsiveness) was shown to be greater than the Disability Rating Index and EQ 5D.
Conclusions
A universally accepted outcome measure is imperative to allow comparisons to be made across practice. This is the first study to evaluate aspects of validity of this newly developed outcome measure, outside of the developing centre. The ATRS demonstrated high internal consistency and responsiveness, with limited convergent validity. This research provides further support for the use of this outcome measure, however further research is required to advocate its universal use in patients with acute Achilles tendon ruptures. Such areas include inter-rater reliability and research to determine the minimally clinically important difference between scores.
All authors have read and concur with the content of this manuscript. The material presented has not been and will not be submitted for publication elsewhere, except as an abstract. All authors have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content and (3) final approval of the submitted version. This research has been funded by Arthritis Research UK, no conflicts of interests have been declared by the authors.
Kind Regards
Rebecca Kearney (corresponding author)
Research Physiotherapist
doi:10.1186/1477-7525-10-24
PMCID: PMC3305449  PMID: 22376047
Achilles tendon; Rupture; Questionnaires; Treatment Outcome
16.  The Warwick patellofemoral arthroplasty trial: a randomised clinical trial of total knee arthroplasty versus patellofemoral arthroplasty in patients with severe arthritis of the patellofemoral joint 
Background
Severe arthritis of the knee is a disabling condition, with over 50,000 knee replacements performed each year in the UK. Isolated patellofemoral joint arthritis occurs in over 10% of these patients with the treatment options being patellofemoral arthroplasty or total knee arthroplasty. Whilst many surgeons believe total knee arthroplasty is the 'gold standard' treatment for severe knee arthritis, patellofemoral arthroplasty has certain potential advantages. Primarily, because this operation allows the patient to keep the majority of their own knee joint; preserving bone-stock and the patients' own ligaments. Patellofemoral arthroplasty has also been recognised as a less 'invasive' operation than primary total knee arthroplasty, facilitating a more rapid recovery. There are currently no published results of randomised clinical trials comparing the two arthroplasty techniques. The primary objective of the current study is to assess whether there is a difference in functional knee scores and quality of life outcome assessments at one year post-operation between patellofemoral arthroplasty and total knee arthroplasty. The secondary objective is to assess the complication rates for both procedures.
Methods/design
Patients who are deemed suitable, by an Orthopaedic Consultant, for patellofemoral arthroplasty and medically fit for surgery are eligible to take part in this trial. The consenting patients will be randomised in a 1:1 allocation to a total knee or patellofemoral arthroplasty. The randomisation sequence will be computer generated and administered by a central independent randomisation service. Following consent, all participants will have their knee function, quality of life and physical activity level assessed through questionnaires. The assigned surgery will then be performed using the preferred technique and implant of the operating surgeon. The first post-operative assessments will take place at six weeks, followed by further assessments at 3, 6 and 12 months. At each assessment time point all complications will be recorded. In addition, community and social care services usage will be collected using a patient questionnaire at 3, 6 & 12 months. The patients will then be sent an annual postal questionnaire. The questionnaire will ask about any problems, knee pain and function following their knee arthroplasty to monitor long-term function and failure rates.
Discussion
This trial is expected to deliver results in early 2013.
Trial Registration
ISRCTN: ISRCTN34863373
UKCRN portfolio ID 6847
doi:10.1186/1471-2474-12-265
PMCID: PMC3235978  PMID: 22111771
17.  UK DRAFFT - A randomised controlled trial of percutaneous fixation with kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius 
Background
Fractures of the distal radius are extremely common injuries in adults. However, the optimal management remains controversial. In general, fractures of the distal radius are treated non-operatively if the bone fragments can be held in anatomical alignment by a plaster cast or orthotic. However, if this is not possible, then operative fixation is required. There are several operative options but the two most common in the UK, are Kirschner-wire fixation (K-wires) and volar plate fixation using fixed-angle screws (locking-plates). The primary aim of this trial is to determine if there is a difference in the Patient-Reported Wrist Evaluation one year following K-wire fixation versus locking-plate fixation for adult patients with a dorsally-displaced fracture of the distal radius.
Methods/design
All adult patients with an acute, dorsally-displaced fracture of the distal radius, requiring operative fixation are potentially eligible to take part in this study. A total of 390 consenting patients will be randomly allocated to either K-wire fixation or locking-plate fixation. The surgery will be performed in trauma units across the UK using the preferred technique of the treating surgeon. Data regarding wrist function, quality of life, complications and costs will be collected at six weeks and three, six and twelve months following the injury. The primary outcome measure will be wrist function with a parallel economic analysis.
Discussion
This pragmatic, multi-centre trial is due to deliver results in December 2013.
Trial registration
Current Controlled Trials ISRCTN31379280
UKCRN portfolio ID 8956
doi:10.1186/1471-2474-12-201
PMCID: PMC3182964  PMID: 21914196
18.  The comprehensive cohort model in a pilot trial in orthopaedic trauma 
Background
The primary aim of this study was to provide an estimate of effect size for the functional outcome of operative versus non-operative treatment for patients with an acute rupture of the Achilles tendon using accelerated rehabilitation for both groups of patients. The secondary aim was to assess the use of a comprehensive cohort research design (i.e. a parallel patient-preference group alongside a randomised group) in improving the accuracy of this estimate within an orthopaedic trauma setting.
Methods
Pragmatic randomised controlled trial and comprehensive cohort study within a level 1 trauma centre. Twenty randomised participants (10 operative and 10 non-operative) and 29 preference participants (3 operative and 26 non-operative). The ge range was 22-72 years and 37 of the 52 patients were men. All participants had an acute rupture of their Achilles tendon and no other injuries. All of the patients in the operative group had a simple end-to-end repair of the tendon with no augmentation. Both groups then followed the same eight-week immediate weight-bearing rehabilitation programme using an off-the-shelf orthotic. The disability rating index (DRI; primary outcome), EQ-5D, Achilles Total Rupture Score and complications were assessed ed at two weeks, six weeks, three months, six months and nine months after initial injury.
Results
At nine months, there was no significant difference in DRI between patients randomised to operative or non-operative management. There was no difference in DRI between the randomised group and the parallel patient preference group. The use of a comprehensive cohort of patients did not provide useful additional information as to the treatment effect size because the majority of patients chose non-operative management.
Conclusions
Recruitment to clinical trials that compare operative and non-operative interventions is notoriously difficult; especially within the trauma setting. Including a parallel patient preference group to create a comprehensive cohort of patients has been suggested as a way of increasing the power of such trials. In our study, the comprehensive cohort model doubled the number of patients involved in the study. However, a strong preference for non-operative treatment meant that the increased number of patients did not significantly increase the ability of the trial to detect a difference between the two interventions.
Trial registration
ISRCTN: ISRCTN29053307
doi:10.1186/1471-2288-11-39
PMCID: PMC3083383  PMID: 21466700
19.  Warwick Hip Trauma Study: a randomised clinical trial comparing interventions to improve outcomes in internally fixed intracapsular fractures of the proximal femur. Protocol for The WHiT Study 
Background
Controversy exists regarding the optimal treatment for patients with displaced intracapsular fractures of the proximal femur. The recognised treatment alternatives are arthroplasty and internal fixation. The principal criticism of internal fixation is the high rate of non-union; up to 30% of patients will have a failure of the fixation leading to revision surgery. We believe that improved fracture healing may lead to a decreased rate of failure of fixation. We therefore propose to investigate strategies to both accelerate fracture healing and improve fixation that may significantly improve outcomes after internal fixation of intracapsular femoral fractures. We aim to test the clinical effectiveness of the osteoinductive agent platelet rich plasma and conduct a pilot study of a novel fixed-angle fixation system.
Design
We have planned a three arm, single centre, standard-of-care controlled, double blinded, pragmatic, randomised clinical trial. The trial will include a standard two-way comparison between platelet-rich plasma and standard-of-care fixation versus standard-of-care fixation alone. In addition there will be a subsidiary pilot arm testing a fixed-angle screw and plate fixation system.
Trial Registration
Current Controlled Trials ISRCTN49197425
doi:10.1186/1471-2474-11-184
PMCID: PMC2928173  PMID: 20716348
20.  Utilization of Immunoglobulin G Fc Receptors by Human Immunodeficiency Virus Type 1: a Specific Role for Antibodies against the Membrane-Proximal External Region of gp41▿  
Journal of Virology  2009;83(15):7397-7410.
Receptors (FcγRs) for the constant region of immunoglobulin G (IgG) are an important link between humoral immunity and cellular immunity. To help define the role of FcγRs in determining the fate of human immunodeficiency virus type 1 (HIV-1) immune complexes, cDNAs for the four major human Fcγ receptors (FcγRI, FcγRIIa, FcγRIIb, and FcγRIIIa) were stably expressed by lentiviral transduction in a cell line (TZM-bl) commonly used for standardized assessments of HIV-1 neutralization. Individual cell lines, each expressing a different FcγR, bound human IgG, as evidence that the physical properties of the receptors were preserved. In assays with a HIV-1 multisubtype panel, the neutralizing activities of two monoclonal antibodies (2F5 and 4E10) that target the membrane-proximal external region (MPER) of gp41 were potentiated by FcγRI and, to a lesser extent, by FcγRIIb. Moreover, the neutralizing activity of an HIV-1-positive plasma sample known to contain gp41 MPER-specific antibodies was potentiated by FcγRI. The neutralizing activities of monoclonal antibodies b12 and 2G12 and other HIV-1-positive plasma samples were rarely affected by any of the four FcγRs. Effects with gp41 MPER-specific antibodies were moderately stronger for IgG1 than for IgG3 and were ineffective for Fab. We conclude that FcγRI and FcγRIIb facilitate antibody-mediated neutralization of HIV-1 by a mechanism that is dependent on the Fc region, IgG subclass, and epitope specificity of antibody. The FcγR effects seen here suggests that the MPER of gp41 could have greater value for vaccines than previously recognized.
doi:10.1128/JVI.00656-09
PMCID: PMC2708617  PMID: 19458010
21.  A randomised controlled trial of total hip arthroplasty versus resurfacing arthroplasty in the treatment of young patients with arthritis of the hip joint 
Background
Hip replacement (arthroplasty) surgery is a highly successful treatment for patients with severe symptomatic arthritis of the hip joint. For older patients, several designs of Total Hip Arthroplasty have shown excellent results in terms of both function and value for money. However, in younger more active patients, there is approximately a 50% failure rate at 25 years for traditional implants. Hip resurfacing is a relatively new arthroplasty technique. In a recent review of the literature on resurfacing arthroplasty it was concluded that the short-term functional results appear promising but some potential early disadvantages were identified, including the risk of femoral neck fracture and collapse of the head of the femur. The aim of the current study is to assess whether there is a difference in functional hip scores at one year post-operation between Total Hip Arthroplasty and Resurfacing Arthroplasty. Secondary aims include assessment of complication rates for both procedures as well cost effectiveness.
Methods/design
All patients medically fit for surgery and deemed suitable for a resurfacing arthroplasty are eligible to take part in this study. A randomisation sequence will be produced and administered independently. After consenting, all patients will be clinically reviewed and hip function, quality of life and physical activity level will be assessed through questionnaires. The allocated surgery will then be performed with the preferred technique of the surgeon. Six weeks post-operation hip function will be assessed and complications recorded. Three, six and 12 months post-operation hip function, quality of life and physical activity level will be assessed. Additional information about patients' out-of-pocket expenses will also be collected.
Trial registration
Current Controlled Trials ISRCTN33354155
UKCLRN portfolio ID 4093
doi:10.1186/1471-2474-11-8
PMCID: PMC2826290  PMID: 20074324
22.  Total hip arthroplasty versus resurfacing arthroplasty in the treatment of patients with arthritis of the hip joint: single centre, parallel group, assessor blinded, randomised controlled trial 
Objectives To compare the clinical and cost effectiveness of total hip arthroplasty with resurfacing arthroplasty in patients with severe arthritis of the hip.
Design Single centre, two arm, parallel group, assessor blinded, randomised controlled trial with 1:1 treatment allocation.
Setting One large teaching hospital in the United Kingdom.
Participants 126 patients older than 18 years with severe arthritis of the hip joint, suitable for resurfacing arthroplasty of the hip. Patients were excluded if they were considered to be unable to adhere to trial procedures or complete questionnaires.
Interventions Total hip arthroplasty (replacement of entire femoral head and neck); hip resurfacing arthroplasty (replacement of the articular surface of femoral head only, femoral neck remains intact). Both procedures replaced the articular surface of the acetabulum.
Main outcome measures Hip function at 12 months after surgery, assessed using the Oxford hip score and Harris hip score. Secondary outcomes were quality of life, disability rating, physical activity level, complications, and cost effectiveness.
Results 60 patients were randomly assigned to hip resurfacing arthroplasty and 66 to total hip arthroplasty. Intention to treat analysis showed no evidence for a difference in hip function between treatment groups at 12 months (t test, P=0.242 and P=0.070 for Oxford hip score and Harris hip score, respectively); 95% of follow-up data was available for analysis. Mean Oxford hip score was 40.4 (95% confidence interval 37.9 to 42.9) in the resurfacing group and 38.2 (35.3 to 41.0) in the total arthroplasty group (estimated treatment effect size 2.23 (−1.52 to 5.98)). Mean Harris hip score was 88.4 (84.4 to 92.4) in the resurfacing group and 82.3 (77.2 to 87.5) in the total arthroplasty group (6.04 (−0.51 to 12.58)). Although we saw no evidence of a difference, we cannot definitively exclude clinically meaningful differences in hip function in the short term. Overall complication rates did not differ between treatment groups (P=0.291). However, we saw more wound complications in the total arthroplasty group (P=0.056) and more thromboembolic events in the resurfacing group (P=0.049).
Conclusions No evidence of a difference in hip function was seen in patients with severe arthritis of the hip, one year after receiving a total hip arthroplasty versus resurfacing arthroplasty. The long term effects of these interventions remain uncertain.
Trial registration Current Controlled Trials ISRCTN33354155, UKCRN 4093.
doi:10.1136/bmj.e2147
PMCID: PMC3330050  PMID: 22517930
23.  Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial 
Objectives To compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius.
Design A multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation.
Setting 18 trauma centres in the United Kingdom.
Participants 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction.
Interventions Kirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws.
Main outcome measures Primary outcome measure: validated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient’s experience of pain and disability to give a score out of 100. Secondary outcomes: disabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery.
Results The baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was −1.3, 95% confidence interval −4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group.
Conclusions Contrary to the existing literature, and against the rapidly increasing use of locking plate fixation, this trial found no difference in functional outcome in patients with dorsally displaced fractures of the distal radius treated with Kirschner wires or volar locking plates. Kirschner wire fixation, however, is cheaper and quicker to perform.
Trial registration Current Controlled Trials ISCRTN 31379280. UKCRN 8956.
doi:10.1136/bmj.g4807
PMCID: PMC4122170  PMID: 25096595

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