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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. 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. 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.


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. Results. Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. Conclusions. A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management. Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481–489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1


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. Discussion. Evidence on the optimum choice of prosthesis for hemiarthroplasty of the hip is lacking. National guidance is currently based on expert opinion rather than empirical evidence. The incidence of hip fracture is likely to continue to increase and providing high quality evidence on the optimum treatment will improve patient outcomes and have important health economic implications. Cite this article: A. L. Sims. The World Hip Trauma Evaluation Study 3: Hemiarthroplasty Evaluation by Multicentre Investigation – WH. I. TE 3: HEMI – An Abridged Protocol. Bone Joint Res 2016;5:18–25. doi: 10.1302/2046-3758.51.2000473


Bone & Joint Research
Vol. 3, Issue 12 | Pages 335 - 340
1 Dec 2014
Handoll HHG Goodchild L Brealey SD Hanchard NCA Jefferson L Keding A Rangan A

Objectives . A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. Methods . These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. Results. All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. Conclusion . In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335–40


Bone & Joint Research
Vol. 6, Issue 4 | Pages 216 - 223
1 Apr 2017
Ang BFH Chen JY Yew AKS Chua SK Chou SM Chia SL Koh JSB Howe TS

Objectives

External fixators are the traditional fixation method of choice for contaminated open fractures. However, patient acceptance is low due to the high profile and therefore physical burden of the constructs. An externalised locking compression plate is a low profile alternative. However, the biomechanical differences have not been assessed. The objective of this study was to evaluate the axial and torsional stiffness of the externalised titanium locking compression plate (ET-LCP), the externalised stainless steel locking compression plate (ESS-LCP) and the unilateral external fixator (UEF).

Methods

A fracture gap model was created to simulate comminuted mid-shaft tibia fractures using synthetic composite bones. Fifteen constructs were stabilised with ET-LCP, ESS-LCP or UEF (five constructs each). The constructs were loaded under both axial and torsional directions to determine construct stiffness.


Bone & Joint Research
Vol. 3, Issue 6 | Pages 187 - 192
1 Jun 2014
Penn-Barwell JG Rand BCC Brown KV Wenke JC

Objectives

The purpose of this study was to refine an accepted contaminated rat femur defect model to result in an infection rate of approximately 50%. This threshold will allow examination of treatments aimed at reducing infection in open fractures with less risk of type II error.

Methods

Defects were created in the stablised femurs of anaethetised rats, contaminated with Staphylococcus aureus and then debrided and irrigated six hours later. After 14 days, the bone and implants were harvested for separate microbiological analysis. This basic model was developed in several studies by varying the quantity of bacterial inoculation, introducing various doses of systemic antibiotics with and without local antibiotics.


Bone & Joint Research
Vol. 1, Issue 4 | Pages 50 - 55
1 Apr 2012
O’Neill F Condon F McGloughlin T Lenehan B Coffey C Walsh M

Introduction

The objective of this study was to determine if a synthetic bone substitute would provide results similar to bone from osteoporotic femoral heads during in vitro testing with orthopaedic implants. If the synthetic material could produce results similar to those of the osteoporotic bone, it could reduce or eliminate the need for testing of implants on bone.

Methods

Pushout studies were performed with the dynamic hip screw (DHS) and the DHS Blade in both cadaveric femoral heads and artificial bone substitutes in the form of polyurethane foam blocks of different density. The pushout studies were performed as a means of comparing the force displacement curves produced by each implant within each material.


Bone & Joint Research
Vol. 1, Issue 6 | Pages 111 - 117
1 Jun 2012
von Recum J Matschke S Jupiter JB Ring D Souer J Huber M Audigé L

Objectives

To investigate the differences of open reduction and internal fixation (ORIF) of complex AO Type C distal radius fractures between two different models of a single implant type.

Methods

A total of 136 patients who received either a 2.4 mm (n = 61) or 3.5 mm (n = 75) distal radius locking compression plate (LCP DR) using a volar approach were followed over two years. The main outcome measurements included motion, grip strength, pain, and the scores of Gartland and Werley, the Short-Form 36 (SF-36) and the Disabilities of the Arm, Shoulder, and Hand (DASH). Differences between the treatment groups were evaluated using regression analysis and the likelihood ratio test with significance based on the Bonferroni corrected p-value of < 0.003.


Bone & Joint Research
Vol. 1, Issue 6 | Pages 118 - 124
1 Jun 2012
Grawe B Le T Williamson S Archdeacon A Zardiackas L

Objectives

We aimed to further evaluate the biomechanical characteristics of two locking screws versus three standard bicortical screws in synthetic models of normal and osteoporotic bone.

Methods

Synthetic tubular bone models representing normal bone density and osteoporotic bone density were used. Artificial fracture gaps of 1 cm were created in each specimen before fixation with one of two constructs: 1) two locking screws using a five-hole locking compression plate (LCP) plate; or 2) three non-locking screws with a seven-hole LCP plate across each side of the fracture gap. The stiffness, maximum displacement, mode of failure and number of cycles to failure were recorded under progressive cyclic torsional and eccentric axial loading.