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Bone & Joint Open
Vol. 4, Issue 9 | Pages 676 - 681
5 Sep 2023
Tabu I Goh EL Appelbe D Parsons N Lekamwasam S Lee J Amphansap T Pandey D Costa M

Aims

The aim of this study was to describe the current pathways of care for patients with a fracture of the hip in five low- and middle-income countries (LMIC) in South Asia (Nepal and Sri Lanka) and Southeast Asia (Malaysia, Thailand, and the Philippines).

Methods

The World Health Organization Service Availability and Readiness Assessment tool was used to collect data on the care of hip fractures in Malaysia, Thailand, the Philippines, Sri Lanka, and Nepal. Respondents were asked to provide details about the current pathway of care for patients with hip fracture, including pre-hospital transport, time to admission, time to surgery, and time to weightbearing, along with healthcare professionals involved at different stages of care, information on discharge, and patient follow-up.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 795 - 800
1 Jul 2023
Parsons N Achten J Costa ML

Aims

To report the outcomes of patients with a fracture of the distal tibia who were treated with intramedullary nail versus locking plate in the five years after participating in the Fixation of Distal Tibia fracture (FixDT) trial.

Methods

The FixDT trial reported the results for 321 patients randomized to nail or locking plate fixation in the first 12 months after their injury. In this follow-up study, we report the results of 170 of the original participants who agreed to be followed up until five years. Participants reported their Disability Rating Index (DRI) and health-related quality of life (EuroQol five-dimension three-level questionnaire) annually by self-reported questionnaire. Further surgical interventions related to the fracture were also recorded.


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1802 - 1808
1 Dec 2021
Bruce J Knight R Parsons N Betteridge R Verdon A Brown J Campolier M Achten J Costa ML

Aims

Deep surgical site infection (SSI) is common after lower limb fracture. We compared the diagnosis of deep SSI using alternative methods of data collection and examined the agreement of clinical photography and in-person clinical assessment by the Centers for Disease Control and Prevention (CDC) criteria after lower limb fracture surgery.

Methods

Data from two large, UK-based multicentre randomized controlled major trauma trials investigating SSI and wound healing after surgical repair of open lower limb fractures that could not be primarily closed (UK WOLLF), and surgical incisions for fractures that were primarily closed (UK WHiST), were examined. Trial interventions were standard wound care management and negative pressure wound therapy after initial surgical debridement. Wound outcomes were collected from 30 days to six weeks. We compared the level of agreement between wound photography and clinical assessment of CDC-defined SSI. We are also assessed the level of agreement between blinded independent assessors of the photographs.


Aims

We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial.

Methods

HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months.


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1469 - 1474
1 Nov 2020
Trompeter AJ Knight R Parsons N Costa ML

Aims

To describe a new objective classification for open fractures of the lower limb and to correlate the classification with patient-centred outcomes.

Methods

The proposed classification was investigated within a cohort of adults with open fractures of the lower limb who were recruited as part of two large clinical trials within the UK Major Trauma Network. The classification was correlated with patient-reported Disability Rating Index (DRI) and EuroQol five-dimension questionnaire (EQ-5D) health-related quality of life in the year after injury, and with deep infection at 30 days, according to the Centers for Disease Control and Prevention definition of a deep surgical site infection.


The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1072 - 1081
1 Aug 2020
Png ME Madan JJ Dritsaki M Achten J Parsons N Fernandez M Grant R Nanchahal J Costa ML

Aims

To compare the cost-utility of standard dressing with incisional negative-pressure wound therapy (iNPWT) in adults with closed surgical wounds associated with major trauma to the lower limbs.

Methods

A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective based on data collected from the Wound Healing in Surgery for Trauma (WHiST) multicentre randomized clinical trial. Health resource utilization was collected over a six-month post-randomization period using trial case report forms and participant-completed questionnaires. Cost-utility was reported in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was conducted to test the robustness of cost-effectiveness estimates while uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves.


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1392 - 1401
1 Nov 2019
Petrou S Parker B Masters J Achten J Bruce J Lamb SE Parsons N Costa ML

Aims

The aim of this study was to estimate the cost-effectiveness of negative-pressure wound therapy (NPWT) in comparison with standard wound management after initial surgical wound debridement in adults with severe open fractures of the lower limb.

Patients and Methods

An economic evaluation was conducted from the perspective of the United Kingdom NHS and Personal Social Services, based on evidence from the 460 participants in the Wound Management of Open Lower Limb Fractures (WOLLF) trial. Economic outcomes were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Bivariate regression of costs (given in £, 2014 to 2015 prices) and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained associated with NPWT dressings. Sensitivity and subgroup analyses were undertaken to assess the impacts of uncertainty and heterogeneity, respectively, surrounding aspects of the economic evaluation.


Aims

This study aimed to compare the change in health-related quality of life of patients receiving a traditional cemented monoblock Thompson hemiarthroplasty compared with a modern cemented modular polished-taper stemmed hemiarthroplasty for displaced intracapsular hip fractures.

Patients and Methods

This was a pragmatic, multicentre, multisurgeon, two-arm, parallel group, randomized standard-of-care controlled trial. It was embedded within the WHiTE Comprehensive Cohort Study. The sample size was 964 patients. The setting was five National Health Service Trauma Hospitals in England. A total of 964 patients over 60 years of age who required hemiarthroplasty of the hip between February 2015 and March 2016 were included. A standardized measure of health outcome, the EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and at four months following the operation.


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 846 - 850
1 Jun 2016
Hoskins W Sheehy R Edwards ER Hau RC Bucknill A Parsons N Griffin XL

Aims

Fractures of the distal femur are an important cause of morbidity. Their optimal management remains controversial. Contemporary implants include angular-stable anatomical locking plates and locked intramedullary nails (IMNs). We compared the long-term patient-reported functional outcome of fixation of fractures of the distal femur using these two methods of treatment.

Patients and Methods

A total of 297 patients were retrospectively identified from a State-wide trauma registry in Australia: 195 had been treated with a locking plate and 102 with an IMN. Baseline characteristics of the patients and their fractures were recorded. Health-related quality-of-life, functional and radiographic outcomes were compared using mixed effects regression models at six months and one year.


The Bone & Joint Journal
Vol. 98-B, Issue 5 | Pages 686 - 689
1 May 2016
Griffin XL Parsons N McArthur J Achten J Costa ML

Aims

The aim of this study was to inform a definitive trial which could determine the clinical effectiveness of the X-Bolt Dynamic Hip Plating System compared with the sliding hip screw for patients with complex pertrochanteric fragility fractures of the femur.

Patients and Methods

This was a single centre, participant blinded, randomised, standard-of-care controlled pilot trial. Patients aged 60 years and over with AO/ASIF A2 and A3 type femoral pertrochanteric fractures were eligible.


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 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 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 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.


Bone & Joint Research
Vol. 2, Issue 10 | Pages 210 - 213
1 Oct 2013
Griffin XL McArthur J Achten J Parsons N Costa ML

Fractures of the proximal femur are one of the greatest challenges facing the medical community, constituting a heavy socioeconomic burden worldwide. Controversy exists regarding the optimal treatment for independent patients with displaced intracapsular fractures of the proximal femur. The recognised alternatives are hemiarthroplasty and total hip replacement. At present there is no established standard of care, with both types of arthroplasty being used in many centres. The principal advantages of total hip replacement are a functional benefit over hemiarthroplasty and a reduced risk of revision surgery. The principal criticism is the increased risk of dislocation. We believe that an alternative acetabular component may reduce the risk of dislocation but still provide the functional benefit of total hip replacement in these patients. We therefore propose to investigate the dislocation risk of a dual-mobility acetabular component compared with standard polyethylene component in total hip replacement for independent patients with displaced intracapsular fractures of the proximal femur within the framework of the larger WHiTE (Warwick Hip Trauma Evaluation) Comprehensive Cohort Study.

Cite this article: Bone Joint Res 2013;2:210–13.


Bone & Joint Research
Vol. 2, Issue 10 | Pages 206 - 209
1 Oct 2013
Griffin XL McArthur J Achten J Parsons N Costa ML

Fractures of the proximal femur are one of the greatest challenges facing the medical community, constituting a heavy socioeconomic burden worldwide. Controversy exists regarding the optimal treatment for patients with unstable trochanteric proximal femoral fractures. The recognised treatment alternatives are extramedullary fixation usually with a sliding hip screw and intramedullary fixation with a cephalomedullary nail. Current evidence suggests that best results and lowest complication rates occur using a sliding hip screw. Complications in these difficult fractures are relatively common regardless of type of treatment. We believe that a novel device, the X-Bolt dynamic plating system, may offer superior fixation over a sliding hip screw with lower reoperation risk and better function. We therefore propose to investigate the clinical effectiveness of the X-bolt dynamic plating system compared with standard sliding hip screw fixation within the framework of a the larger WHiTE (Warwick Hip Trauma Evaluation) Comprehensive Cohort Study.

Cite this article: Bone Joint Res 2013;2:206–9.


Bone & Joint Research
Vol. 1, Issue 11 | Pages 310 - 314
1 Nov 2012
Griffin XL Achten J Parsons N Boardman F Griffiths F Costa ML

Fractures of the proximal femur are one of the greatest challenges facing the medical community, constituting a heavy socioeconomic burden worldwide. The National Hip Fracture Audit currently provides a framework for service evaluation. This evaluation is based upon the assessment of process rather than assessment of patient-centred outcome and therefore it fails to provide meaningful data regarding the clinical effectiveness of treatments. This study aims to capture data from the cohort of patients who present with a fracture of the proximal femur at a single United Kingdom Major Trauma Centre. Patient-centred outcomes will be recorded and provide a baseline cohort within which to test the clinical effectiveness of experimental interventions.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 447 - 447
1 Sep 2012
Kulikov Y Parsons N Griffin D
Full Access

Introduction

There is an ever increasing demand for Randomised Controlled Trials (RCTs) in Trauma and Orthopaedic Surgery. Patient recruitment is often challenging. Among other factors, individual surgeon's preference is often quoted as a major obstacle. Collective equipoise based on present or imminent controversy in the expert medical community has been proposed as a solution, but could not help in everyday running of a trial. We wanted to develop a new trial eligibility assessment tool using the Collective Equipoise Principle.

Methods

We developed an online system that quantifies collective uncertainty among a group of surgeons for an individual clinical case in real time. This data was collected for patients in the UK Heel Fracture Trial (UK HeFT) as an independent research project. Both patients who agreed or not to take part in the trial were approached in six weeks follow up clinic to avoid interference with clinical course. For those who agreed, anonymous clinical data together with images (Xrays and CT) was published on a secure on line forum and registered surgeons were alerted via email and SMS. Surgeons submitted their opinion instantly via specially designed interactive voting scale. 80:20 ethical uncertainty distribution limit was applied using Subjective Logic to calculate an Uncertainty Index (UnIx) for every patient. This approach was evaluated as an eligibility assessment tool for RCTs.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 5 | Pages 704 - 708
1 May 2012
Mauffrey C McGuinness K Parsons N Achten J Costa ML

The ideal form of fixation for displaced, extra-articular fractures of the distal tibia remains controversial. In the UK, open reduction and internal fixation with locking-plates and intramedullary nailing are the two most common forms of treatment. Both techniques provide reliable fixation but both are associated with specific complications. There is little information regarding the functional recovery following either procedure.

We performed a randomised pilot trial to determine the functional outcome of 24 adult patients treated with either a locking-plate (n = 12) or an intramedullary nailing (n = 12). At six months, there was an adjusted difference of 13 points in the Disability Rating Index in favour of the intramedullary nail. However, this was not statistically significant in this pilot trial (p = 0.498). A total of seven patients required further surgery in the locking-plate group and one in the intramedullary nail group.

This study suggests that there may be clinically relevant, functional differences in patients treated with nail versus locking-plate fixation for fractures of the distal tibia and differences in related complications. Further trials are required to confirm the findings of this pilot investigation.