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The Bone & Joint Journal
Vol. 98-B, Issue 3 | Pages 410 - 413
1 Mar 2016
Costa ML Jameson SS Reed MR

Aims

Our aim, using English Hospital Episode Statistics data before during and after the Distal Radius Acute Fracture Fixation Trial (DRAFFT), was to assess whether the results of the trial affected clinical practice.

Patients and Methods

Data were grouped into six month intervals from July 2005 to December 2014. All patient episodes in the National Health Service involving emergency surgery for an isolated distal radial fracture were included.


The Bone & Joint Journal
Vol. 98-B, Issue 3 | Pages 414 - 419
1 Mar 2016
Metcalfe D Gabbe BJ Perry DC Harris MB Ekegren CL Zogg CK Salim A Costa ML

Aims

In this study, we aimed to determine whether designation as a major trauma centre (MTC) affects the quality of care for patients with a fracture of the hip.

Patients and Methods

All patients in the United Kingdom National Hip Fracture Database, between April 2010 and December 2013, were included. The indicators of quality that were recorded included the time to arrival on an orthopaedic ward, to review by a geriatrician, and to operation. The clinical outcomes were the development of a pressure sore, discharge home, length of stay, in-hospital mortality, and re-operation within 30 days.


Bone & Joint Research
Vol. 5, Issue 1 | Pages 18 - 25
1 Jan 2016
Sims AL Parsons N Achten J Griffin XL Costa ML Reed MR

Background

Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes.

Design

This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.


The Bone & Joint Journal
Vol. 97-B, Issue 8 | Pages 1082 - 1089
1 Aug 2015
Tubeuf S Yu G Achten J Parsons NR Rangan A Lamb SE Costa ML

We present an economic evaluation using data from the Distal Radius Acute Fracture Fixation Trial (DRAFFT) to compare the relative cost effectiveness of percutaneous Kirschner wire (K-wire) fixation and volar locking-plate fixation for patients with dorsally-displaced fractures of the distal radius.

The cost effectiveness analysis (cost per quality-adjusted life year; QALY) was derived from a multi-centre, two-arm, parallel group, assessor-blind, randomised controlled trial which took place in 18 trauma centres in the United Kingdom. Data from 460 patients were available for analysis, which includes both a National Health Service cost perspective including costs of surgery, implants and healthcare resource use over a 12-month period after surgery, and a societal perspective, which includes the cost of time off work and the need for additional private care.

There was only a small difference in QALYs gained for patients treated with locking-plate fixation over those treated with K-wires. At a mean additional cost of £714 (95% confidence interval 588 to 865) per patient, locking-plate fixation presented an incremental cost effectiveness ratio (ICER) of £89 322 per QALY within the first 12 months of treatment. Sensitivity analyses were undertaken to assess the ICER of locking-plate fixation compared with K-wires. These were greater than £30 000.

Compared with locking-plate fixation, K-wire fixation is a ‘cost saving’ intervention, with similar health benefits.

Cite this article: Bone Joint J 2015;97-B:1082–9.


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 875 - 879
1 Jul 2015
Fernandez MA Griffin XL Costa ML

Hip fracture is a common injury associated with high mortality, long-term disability and huge socio-economic burden. Yet there has been relatively little research into best treatment, and evidence that has been generated has often been criticised for its poor quality. Here, we discuss the advances made towards overcoming these criticisms and the future directions for hip fracture research: how co-ordinating existing national infrastructures and use of now established clinical research networks will likely go some way towards overcoming the practical and financial challenges of conducting large trials. We highlight the importance of large collaborative pragmatic trials to inform decision/policy makers and the progress made towards reaching a consensus on a core outcome set to facilitate data pooling for evidence synthesis and meta-analysis.

These advances and future directions are a priority in order to establish the high-quality evidence base required for this important group of patients.

Cite this article: Bone Joint J 2015;97-B:875–9.


Bone & Joint Research
Vol. 4, Issue 6 | Pages 93 - 98
1 Jun 2015
Smith NA Achten J Parsons N Wright D Parkinson B Thompson P Hutchinson CE Spalding T Costa ML

Objectives

Subtotal or total meniscectomy in the medial or lateral compartment of the knee results in a high risk of future osteoarthritis. Meniscal allograft transplantation has been performed for over thirty years with the scientifically plausible hypothesis that it functions in a similar way to a native meniscus. It is thought that a meniscal allograft transplant has a chondroprotective effect, reducing symptoms and the long-term risk of osteoarthritis. However, this hypothesis has never been tested in a high-quality study on human participants. This study aims to address this shortfall by performing a pilot randomised controlled trial within the context of a comprehensive cohort study design.

Methods

Patients will be randomised to receive either meniscal transplant or a non-operative, personalised knee therapy program. MRIs will be performed every four months for one year. The primary endpoint is the mean change in cartilage volume in the weight-bearing area of the knee at one year post intervention. Secondary outcome measures include the mean change in cartilage thickness, T2 maps, patient-reported outcome measures, health economics assessment and complications.


The Bone & Joint Journal
Vol. 97-B, Issue 6 | Pages 818 - 823
1 Jun 2015
Plant CE Hickson C Hedley H Parsons NR Costa ML

We conducted an observational radiographic study to determine the inter- and intra-observer reliability of the AO classification of fractures of the distal radius. Plain posteroanterior and lateral radiographs of 456 patients with an acute fracture of the distal radius were classified by a consultant orthopaedic hand specialist and two specialist trainees, and the k coefficient for the inter- and intra-observer reliability of the type, group and subgroup classification was calculated.

Only the type of fracture (A, B or C) was found to provide substantial intra-observer reliability (k type 0.65). The inclusion of ‘group’ and ‘subgroup’ into the classification reduced the inter-observer reliability to fair (kgroup 0.29, ksubgroup = 0.28) and the intra-observer reliability to moderate (kgroup 0.53, ksubgroup 0.49). Disagreement was found to arise between specific subgroups, which may be amenable to clarification.

Cite this article: Bone Joint J 2015; 97-B:818–23.


The Bone & Joint Journal
Vol. 97-B, Issue 5 | Pages 590 - 594
1 May 2015
Smith NA Costa ML Spalding T

The anatomy and microstructure of the menisci allow the effective distribution of load across the knee. Meniscectomy alters the biomechanical environment and is a potent risk factor for osteoarthritis. Despite a trend towards meniscus-preserving surgery, many tears are irreparable, and many repairs fail.

Meniscal allograft transplantation has principally been carried out for pain in patients who have had a meniscectomy. Numerous case series have reported a significant improvement in patient-reported outcomes after surgery, but randomised controlled trials have not been undertaken.

It is scientifically plausible that meniscal allograft transplantation is protective of cartilage, but this has not been established clinically to date.

Cite this article: Bone Joint J 2015; 97-B:590–4.


Bone & Joint Research
Vol. 4, Issue 4 | Pages 65 - 69
1 Apr 2015
Kearney RS Parsons N Underwood M Costa ML

Objectives

The evidence base to inform the management of Achilles tendon rupture is sparse. The objectives of this research were to establish what current practice is in the United Kingdom and explore clinicians’ views on proposed further research in this area. This study was registered with the ISRCTN (ISRCTN68273773) as part of a larger programme of research.

Methods

We report an online survey of current practice in the United Kingdom, approved by the British Orthopaedic Foot and Ankle Society and completed by 181 of its members. A total of ten of these respondents were invited for a subsequent one-to-one interview to explore clinician views on proposed further research in this area.


The Bone & Joint Journal
Vol. 97-B, Issue 3 | Pages 372 - 382
1 Mar 2015
Griffin XL Parsons N Achten J Fernandez M Costa ML

Hip fracture is a global public health problem. The National Hip Fracture Database provides a framework for service evaluation in this group of patients in the United Kingdom, but does not collect patient-reported outcome data and is unable to provide meaningful data about the recovery of quality of life.

We report one-year patient-reported outcomes of a prospective cohort of patients treated at a single major trauma centre in the United Kingdom who sustained a hip fracture between January 2012 and March 2014.

There was an initial marked decline in quality of life from baseline measured using the EuroQol 5 Dimensions score (EQ-5D). It was followed by a significant improvement to 120 days for all patients. Although their quality of life improved during the year after the fracture, it was still significantly lower than before injury irrespective of age group or cognitive impairment (mean reduction EQ-5D 0.22; 95% confidence interval (CI) 0.17 to 0.26). There was strong evidence that quality of life was lower for patients with cognitive impairment. There was a mean reduction in EQ-5D of 0.28 (95% CI 0.22 to 0.35) in patients <  80 years of age. This difference was consistent (and fixed) throughout follow-up. Quality of life does not improve significantly during recovery from hip fracture in patients over 80 years of age (p = 0.928). Secondary measures of function showed similar trends.

Hip fracture marks a step down in the quality of life of a patient: it accounts for approximately 0.22 disability adjusted life years in the first year after fracture. This is equivalent to serious neurological conditions for which extensive funding for research and treatment is made available.

Cite this article: Bone Joint J 2015;97-B:372–82.


The Bone & Joint Journal
Vol. 96-B, Issue 12 | Pages 1578 - 1585
1 Dec 2014
Rankin KS Sprowson AP McNamara I Akiyama T Buchbinder R Costa ML Rasmussen S Nathan SS Kumta S Rangan A

Trauma and orthopaedics is the largest of the surgical specialties and yet attracts a disproportionately small fraction of available national and international funding for health research. With the burden of musculoskeletal disease increasing, high-quality research is required to improve the evidence base for orthopaedic practice. Using the current research landscape in the United Kingdom as an example, but also addressing the international perspective, we highlight the issues surrounding poor levels of research funding in trauma and orthopaedics and indicate avenues for improving the impact and success of surgical musculoskeletal research.

Cite this article: Bone Joint J 2014; 96-B:1578–85.


The Bone & Joint Journal
Vol. 96-B, Issue 12 | Pages 1575 - 1577
1 Dec 2014
Perry DC Parsons N Costa ML

The extent and depth of routine health care data are growing at an ever-increasing rate, forming huge repositories of information. These repositories can answer a vast array of questions. However, an understanding of the purpose of the dataset used and the quality of the data collected are paramount to determine the reliability of the result obtained.

This Editorial describes the importance of adherence to sound methodological principles in the reporting and publication of research using ‘big’ data, with a suggested reporting framework for future Bone & Joint Journal submissions.

Cite this article: Bone Joint J 2014;96-B:1575–7.


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1016 - 1023
1 Aug 2014
Haywood KL Griffin XL Achten J Costa ML

The lack of a consensus for core health outcomes that should be reported in clinical research has hampered study design and evidence synthesis. We report a United Kingdom consensus for a core outcome set (COS) for clinical trials of patients with a hip fracture.

We adopted a modified nominal group technique to derive consensus on 1) which outcome domains should be measured, and 2) methods of assessment. Participants reflected a diversity of perspectives and experience. They received an evidence synthesis and postal questionnaire in advance of the consensus meeting, and ranked the importance of candidate domains and the relevance and suitability of short-listed measures. During the meeting, pre-meeting source data and questionnaire responses were summarised, followed by facilitated discussion and a final plenary session. A COS was determined using a closed voting system: a 70% consensus was required.

Consensus supported a five-domain COS: mortality, pain, activities of daily living, mobility, and health-related quality of life (HRQL). Single-item measures of mortality and mobility (indoor/outdoor walking status) and a generic multi-item measure of HRQL - the EuroQoL EQ-5D - were recommended. These measures should be included as a minimum in all hip fracture trials. Other outcome measures should be added depending on the particular interventions being studied.

Cite this article: Bone Joint J 2014; 96-B:1016–23.


The Bone & Joint Journal
Vol. 96-B, Issue 7 | Pages 853 - 854
1 Jul 2014
Parsons N Griffin XL Stengel D Carey Smith R Perry DC Costa ML

The Bone & Joint Journal provides the latest evidence to guide the clinical practice of orthopaedic surgeons. The benefits of one intervention compared with another are presented using outcome measures; some may be specific to a limb or joint and some are more general health-related quality of life measures. Readers will be familiar with many of these outcome measures and will be able to judge the relative benefits of different interventions when measured using the same outcome tool; for example, different treatments for pain in the knee measured using a particular knee score. But, how should readers compare outcomes between different clinical areas using different outcome measures? This article explores the use of standardised effect sizes.

Cite this article: Bone Joint J 2014;96-B:853–4.


The Bone & Joint Journal
Vol. 96-B, Issue 5 | Pages 652 - 657
1 May 2014
Griffin XL Parsons N Achten J Costa ML

We compared a new fixation system, the Targon Femoral Neck (TFN) hip screw, with the current standard treatment of cannulated screw fixation. This was a single-centre, participant-blinded, randomised controlled trial. Patients aged 65 years and over with either a displaced or undisplaced intracapsular fracture of the hip were eligible. The primary outcome was the risk of revision surgery within one year of fixation.

A total of 174 participants were included in the trial. The absolute reduction in risk of revision was of 4.7% (95% CI 14.2 to 22.5) in favour of the TFN hip screw (chi-squared test, p = 0.741), which was less than the pre-specified level of minimum clinically important difference. There were no significant differences in any of the secondary outcome measures.

We found no evidence of a clinical difference in the risk of revision surgery between the TFN hip screw and cannulated screw fixation for patients with an intracapsular fracture of the hip.

Cite this article: Bone Joint J 2014;96-B:652–7.


Bone & Joint Research
Vol. 3, Issue 4 | Pages 123 - 129
1 Apr 2014
Perry DC Griffin XL Parsons N Costa ML

The surgical community is plagued with a reputation for both failing to engage and to deliver on clinical research. This is in part due to the absence of a strong research culture, however it is also due to a multitude of barriers encountered in clinical research; particularly those involving surgical interventions. ‘Trauma’ amplifies these barriers, owing to the unplanned nature of care, unpredictable work patterns, the emergent nature of treatment and complexities in the consent process. This review discusses the barriers to clinical research in surgery, with a particular emphasis on trauma. It considers how barriers may be overcome, with the aim to facilitate future successful clinical research.

Cite this article: Bone Joint Res 2014;3:123–9.


Bone & Joint Research
Vol. 3, Issue 3 | Pages 69 - 75
1 Mar 2014
Parsons N Griffin XL Achten J Costa ML

Objectives

To study the measurement properties of a joint specific patient reported outcome measure, a measure of capability and a general health-related quality of life (HRQOL) tool in a large cohort of patients with a hip fracture.

Methods

Responsiveness and associations between the Oxford Hip Score (a hip specific measure: OHS), ICEpop CAPability (a measure of capability in older people: ICECAP-O) and EuroQol EQ-5D (general health-related quality of life measure: EQ-5D) were assessed using data available from two large prospective studies. The three outcome measures were assessed concurrently at a number of fixed follow-up time-points in a consecutive sequence of patients, allowing direct assessment of change from baseline, inter-measure associations and validity using a range of statistical methods.


The Bone & Joint Journal
Vol. 95-B, Issue 11 | Pages 1443 - 1444
1 Nov 2013
Griffin XL Parsons N Carey Smith R Stengel D Costa ML

The importance for observing the intention-to-treat approach in clinical studies is explained.

Cite this article: Bone Joint J 2013;95-B:1443–4.


Bone & Joint Research
Vol. 2, Issue 11 | Pages 245 - 247
1 Nov 2013
Sprowson AP Rankin KS McNamara I Costa ML Rangan A

The peer review process for the evaluation of manuscripts for publication needs to be better understood by the orthopaedic community. Improving the degree of transparency surrounding the review process and educating orthopaedic surgeons on how to improve their manuscripts for submission will help improve both the review procedure and resultant feedback, with an increase in the quality of the subsequent publications. This article seeks to clarify the peer review process and suggest simple ways in which the quality of submissions can be improved to maximise publication success.

Cite this article: Bone Joint Res 2013;2:245–7.


Bone & Joint Research
Vol. 2, Issue 10 | Pages 227 - 232
1 Oct 2013
Kearney RS Parsons N Costa ML

Objectives

To conduct a pilot randomised controlled trial to evaluate the feasibility of conducting a larger trial to evaluate the difference in Victorian Institute of Sports Assessment-Achilles (VISA-A) scores at six months between patients with Achilles tendinopathy treated with a platelet-rich plasma (PRP) injection compared with an eccentric loading programme.

Methods

Two groups of patients with mid-substance Achilles tendinopathy were randomised to receive a PRP injection or an eccentric loading programme. A total of 20 patients were randomised, with a mean age of 49 years (35 to 66). All outcome measures were recorded at baseline, six weeks, three months and six months.