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Bone & Joint Open
Vol. 2, Issue 7 | Pages 486 - 492
8 Jul 2021
Phelps EE Tutton E Costa M Hing C

Aims. To explore staff experiences of a multicentre pilot randomized controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures. Methods. A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants’ experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone, and were analyzed using thematic analysis. Results. The findings identify that for the treatment of segmental tibial fractures equipoise was a theoretical ideal that was most likely unattainable in clinical practice. This was conveyed through three themes: the ambiguity of equipoise, where multiple definitions of equipoise and a belief in community equipoise were evident; an illusion of equipoise, created by strong treatment preferences and variation in collective surgical skills; and treating the whole patient, where the complexity and severity of the injury required a patient-centred approach and doing the best for the individual patient took priority over trial recruitment. Conclusion. Equipoise can be unattainable for rare injuries such as segmental tibial fractures, where there are substantially different surgical treatments requiring specific expertise, high levels of complexity, and a concern for poor outcomes. Surgeons are familiar with community equipoise. However, a shared understanding of factors that limit the feasibility of RCTs may identify instances where community equipoise is unlikely to translate into practice. Cite this article: Bone Jt Open 2021;2(7):486–492


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. Results. 70 consecutive patients (77 calcaneal fractures) were assessed by a panel of 12 Consultant Trauma surgeons from hospitals acros the UK. All patients were eligible for the UK HeFT according to standard eligibility criteria approach. UnIx demonstrated reliable correlation with level of uncertainty and confidence about treatment choice expressed by surgeons. The panel was certain about treatment for 9 (13%) patients. The assesment results were available within 48 hours from a case submission to the panel. Discussion and Conclusion. UnIx is an effective and ethical eligibility assessment tool based on surgeon's opinion. It can be calculated for every patient in Randomised Controlled Trials. This protects patients when there is no controversy about treatment choice. UnIx can potentially increase patient recruitment by including more patients for eligibility assessment and more sceptical surgeons in clinical trials. Patient's perception that his/her condition was assessed by surgical panel may also be important


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 401 - 411
1 Apr 2024
Carrothers A O'Leary R Hull P Chou D Alsousou J Queally J Bond SJ Costa ML

Aims

To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment.

Methods

Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture. Feasibility outcomes included patients’ willingness to participate, clinicians’ capability to recruit, and dropout rates. The primary clinical outcome measure was the EuroQol five-dimension questionnaire (EQ-5D) at six months. Secondary outcomes were Oxford Hip Score, Disability Rating Index, blood loss, and radiological and mobility assessments.


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 180 - 189
1 Feb 2023
Tohidi M Mann SM Groome PA

Aims

This study aimed to describe practice variation in the use of total hip arthroplasty (THA) for older patients with femoral neck fracture and to determine the association between patient, surgeon, and institution factors and treatment with THA.

Methods

We performed a cross-sectional analysis of 49,597 patients aged 60 years and older from Ontario, Canada, who underwent hemiarthroplasty or THA for femoral neck fracture between 2002 and 2017. This population-based study used routinely collected healthcare databases linked through ICES (formerly known as the Institute for Clinical Evaluative Sciences). Multilevel logistic regression modelling was used to quantify the association between patient, surgeon, and institution-level variables and whether patients were treated with THA. Variance partition coefficient and median odds ratios were used to estimate the variation attributable to higher-level variables and the magnitude of effect of higher-level variables, respectively.


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 972 - 979
1 Aug 2022
Richardson C Bretherton CP Raza M Zargaran A Eardley WGP Trompeter AJ

Aims

The purpose of this study was to determine the weightbearing practice of operatively managed fragility fractures in the setting of publically funded health services in the UK and Ireland.

Methods

The Fragility Fracture Postoperative Mobilisation (FFPOM) multicentre audit included all patients aged 60 years and older undergoing surgery for a fragility fracture of the lower limb between 1 January 2019 and 30 June 2019, and 1 February 2021 and 14 March 2021. Fractures arising from high-energy transfer trauma, patients with multiple injuries, and those associated with metastatic deposits or infection were excluded. We analyzed this patient cohort to determine adherence to the British Orthopaedic Association Standard, “all surgery in the frail patient should be performed to allow full weight-bearing for activities required for daily living”.


Aims

Our objective was to conduct a systematic review and meta-analysis, to establish whether differences arise in clinical outcomes between autologous and synthetic bone grafts in the operative management of tibial plateau fractures.

Methods

A structured search of MEDLINE, EMBASE, the online archives of Bone & Joint Publishing, and CENTRAL databases from inception until 28 July 2021 was performed. Randomized, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture nonunion, or chondral defects were excluded. Outcome data were assessed using the Risk of Bias 2 (ROB2) framework and synthesized in random-effect meta-analysis. The Preferred Reported Items for Systematic Review and Meta-Analyses guidance was followed throughout.


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 902 - 907
1 May 2021
Marson BA Ng JWG Craxford S Chell J Lawniczak D Price KR Ollivere BJ Hunter JB

Aims

The management of completely displaced fractures of the distal radius in children remains controversial. This study evaluates the outcomes of surgical and non-surgical management of ‘off-ended’ fractures in children with at least two years of potential growth remaining.

Methods

A total of 34 boys and 22 girls aged 0 to ten years with a closed, completely displaced metaphyseal distal radial fracture presented between 1 November 2015 and 1 January 2020. After 2018, children aged ten or under were offered treatment in a straight plaster or manipulation under anaesthesia with Kirschner (K-)wire stabilization. Case notes and radiographs were reviewed to evaluate outcomes. In all, 16 underwent treatment in a straight cast and 40 had manipulation under anaesthesia, including 37 stabilized with K-wires.


Bone & Joint Open
Vol. 1, Issue 10 | Pages 644 - 653
14 Oct 2020
Kjærvik C Stensland E Byhring HS Gjertsen J Dybvik E Søreide O

Aims

The aim of this study was to describe variation in hip fracture treatment in Norway expressed as adherence to international and national evidence-based treatment guidelines, to study factors influencing deviation from guidelines, and to analyze consequences of non-adherence.

Methods

International and national guidelines were identified and treatment recommendations extracted. All 43 hospitals routinely treating hip fractures in Norway were characterized. From the Norwegian Hip Fracture Register (NHFR), hip fracture patients aged > 65 years and operated in the period January 2014 to December 2018 for fractures with conclusive treatment guidelines were included (n = 29,613: femoral neck fractures (n = 21,325), stable trochanteric fractures (n = 5,546), inter- and subtrochanteric fractures (n = 2,742)). Adherence to treatment recommendations and a composite indicator of best practice were analyzed. Patient survival and reoperations were evaluated for each recommendation.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 17 - 25
1 Jan 2020
Trickett RW Mudge E Price P Pallister I

Aims

The aim of this study was to develop a psychometrically sound measure of recovery for use in patients who have suffered an open tibial fracture.

Methods

An initial pool of 109 items was generated from previous qualitative data relating to recovery following an open tibial fracture. These items were field tested in a cohort of patients recovering from an open tibial fracture. They were asked to comment on the content of the items and structure of the scale. Reduction in the number of items led to a refined scale tested in a larger cohort of patients. Principal components analysis permitted further reduction and the development of a definitive scale. Internal consistency, test-retest reliability, and responsiveness were assessed for the retained items.


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1416 - 1422
1 Nov 2019
Rohilla R Sharma PK Wadhwani J Rohilla S Beniwal R Singh R Devgan A

Aims

In this randomized study, we aimed to compare quality of regenerate in monolateral versus circular frame fixation in 30 patients with infected nonunion of tibia.

Patients and Methods

Both groups were comparable in demographic and injury characteristics. A phantom (aluminium step wedge of increasing thickness) was designed to compare the density of regenerate on radiographs. A CT scan was performed at three and six months postoperatively to assess regenerate density. A total of 30 patients (29 male, one female; mean age 32.54 years (18 to 60)) with an infected nonunion of a tibial fracture presenting to our tertiary institute between June 2011 and April 2016 were included in the study.


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1408 - 1415
1 Nov 2019
Hull PD Chou DTS Lewis S Carrothers AD Queally JM Allison A Barton G Costa ML

Aims

The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients.

Patients and Methods

Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients’ willingness to participate, clinicians’ willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury.


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 964 - 972
1 Jul 2017
Duckworth AD Clement ND McEachan JE White TO Court-Brown CM McQueen MM

Aims

The aim of this prospective randomised controlled trial was to compare non-operative and operative management for acute isolated displaced fractures of the olecranon in patients aged ≥ 75 years.

Patients and Methods

Patients were randomised to either non-operative management or operative management with either tension-band wiring or fixation with a plate. They were reviewed at six weeks, three and six months and one year after the injury. The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at one year.


Bone & Joint Research
Vol. 5, Issue 10 | Pages 481 - 489
1 Oct 2016
Handoll HHG Brealey SD Jefferson L Keding A Brooksbank AJ Johnstone AJ Candal-Couto JJ Rangan A

Objectives

Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck.

Methods

The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons.


The Bone & Joint Journal
Vol. 97-B, Issue 1 | Pages 104 - 108
1 Jan 2015
Bretherton CP Parker MJ

There has been extensive discussion about the effect of delay to surgery on mortality in patients sustaining a fracture of the hip. Despite the low level of evidence provided by many studies, a consensus has been accepted that delay of > 48 hours is detrimental to survival. The aim of this prospective observational study was to determine if early surgery confers a survival benefit at 30 days.

Between 1989 and 2013, data were prospectively collected on patients sustaining a fracture of the hip at Peterborough City Hospital. They were divided into groups according to the time interval between admission and surgery. These thresholds ranged from <  6 hours to between 49 and 72 hours. The outcome which was assessed was the 30-day mortality. Adjustment for confounders was performed using multivariate binary logistic regression analysis. In all, 6638 patients aged > 60 years were included.

Worsening American Society of Anaesthesiologists grade (p < 0.001), increased age (p <  0.001) and extracapsular fracture (p < 0.019) increased the risk of 30-day mortality.

Increasing mobility score (p = 0.014), mini mental test score (p < 0.001) and female gender (p = 0.014) improved survival. After adjusting for these confounders, surgery before 12 hours improved survival compared with surgery after 12 hours (p = 0.013). Beyond this the increasing delay to surgery did not significantly affect the 30-day mortality.

Cite this article: Bone Joint J 2015;97-B:104–8.