Clinical studies of patients with bone sarcomas have been challenged
by insufficient numbers at individual centres to draw valid conclusions.
Our objective was to assess the feasibility of conducting a definitive
multi-centre randomised controlled trial (RCT) to determine whether
a five-day regimen of post-operative antibiotics, in comparison
to a
24-hour regimen, decreases surgical site infections in patients
undergoing endoprosthetic reconstruction for lower extremity primary
bone tumours. We performed a pilot international multi-centre RCT. We used
central randomisation to conceal treatment allocation and sham antibiotics
to blind participants, surgeons, and data collectors. We determined
feasibility by measuring patient enrolment, completeness of follow-up,
and protocol deviations for the antibiotic regimens. Objective
Methods
Femoral stem version has a major influence on
impingement and early post-operative stability after total hip arthroplasty
(THA). The main objective of this study was to evaluate the validity
of a novel radiological method for measuring stem version. Anteroposterior
(AP) radiographs and three-dimensional CT scans were obtained for
115 patients (female/male 63/72, mean age 62.5 years (50 to 75))
who had undergone minimally invasive, cementless THA. Stem version was
calculated from the AP hip radiograph by rotation-based change in
the projected prosthetic neck–shaft (NSA*) angle using the mathematical
formula ST = arcos [tan (NSA*) / tan (135)]. We used two independent
observers who repeated the analysis after a six-week interval. Radiological
measurements were compared with 3D-CT measurements by an independent,
blinded external institute. We found a mean difference of 1.2° ( We found that femoral tilt was associated with the mean radiological
measurement error (r = 0.22, p = 0.02). The projected neck–shaft angle is a reliable method for measuring
stem version on AP radiographs of the hip after a THA. However,
a highly standardised radiological technique is required for its
precise measurement. Cite this article:
The purpose of this study was to undertake a
meta-analysis to determine whether there is lower polyethylene wear and
longer survival when using mobile-bearing implants in total knee
replacement when compared with fixed-bearing implants. Of 975 papers
identified, 34 trials were eligible for data extraction and meta-analysis
comprising 4754 patients (6861 knees). We found no statistically
significant differences between the two designs in terms of the incidence
of radiolucent lines, osteolysis, aseptic loosening or survival.
There is thus currently no evidence to suggest that the use of mobile-bearing
designs reduce polyethylene wear and prolong survival after total
knee replacement. Cite this article:
The routine use of patient reported outcome measures
(PROMs) in evaluating the outcome after arthroplasty by healthcare
organisations reflects a growing recognition of the importance of
patients’ perspectives in improving treatment. Although widely embraced
in the NHS, there are concerns that PROMs are being used beyond
their means due to a poor understanding of their limitations. This paper reviews some of the current challenges in using PROMs
to evaluate total knee arthroplasty. It highlights alternative methods
that have been used to improve the assessment of outcome. Cite this article:
Most patients with a nightstick fracture of the
ulna are treated conservatively. Various techniques of immobilisation or
early mobilisation have been studied. We performed a systematic
review of all published randomised controlled trials and observational
studies that have assessed the outcome of these fractures following
above- or below-elbow immobilisation, bracing and early mobilisation.
We searched multiple electronic databases, related bibliographies and
other studies. We included 27 studies comprising 1629 fractures
in the final analysis. The data relating to the time to radiological
union and the rates of delayed union and nonunion could be pooled
and analysed statistically. We found that early mobilisation produced the shortest radiological
time to union (mean 8.0 weeks) and the lowest mean rate of nonunion
(0.6%). Fractures treated with above- or below-elbow immobilisation
and braces had longer mean radiological times to union (9.2 weeks,
9.2 weeks and 8.7 weeks, respectively) and higher mean rates of
nonunion (3.8%, 2.1% and 0.8%, respectively). There was no statistically
significant difference in the rate of non- or delayed union between
those treated by early mobilisation and the three forms of immobilisation
(p = 0.142 to p = 1.000, respectively). All the studies had significant
biases, but until a robust randomised controlled trial is undertaken
the best advice for the treatment of undisplaced or partially displaced
nightstick fractures appears to be early mobilisation, with a removable
forearm support for comfort as required. Cite this article:
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:
Femoroacetabular Junction Impingement (FAI) describes abnormalities
in the shape of the femoral head–neck junction, or abnormalities
in the orientation of the acetabulum. In the short term, FAI can
give rise to pain and disability, and in the long-term it significantly increases
the risk of developing osteoarthritis. The Femoroacetabular Impingement
Trial (FAIT) aims to determine whether operative or non-operative
intervention is more effective at improving symptoms and preventing
the development and progression of osteoarthritis. FAIT is a multicentre superiority parallel two-arm randomised
controlled trial comparing physiotherapy and activity modification
with arthroscopic surgery for the treatment of symptomatic FAI.
Patients aged 18 to 60 with clinical and radiological evidence of
FAI are eligible. Principal exclusion criteria include previous
surgery to the index hip, established osteoarthritis (Kellgren–Lawrence
≥ 2), hip dysplasia (centre-edge angle <
20°), and completion
of a physiotherapy programme targeting FAI within the previous 12
months. Recruitment will take place over 24 months and 120 patients
will be randomised in a 1:1 ratio and followed up for three years.
The two primary outcome measures are change in hip outcome score
eight months post-randomisation (approximately six-months post-intervention
initiation) and change in radiographic minimum joint space width
38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Aims
Methods
Opinion remains divided as to whether the development
of pathological fracture affects the prognosis of patients with
an osteosarcoma of the extremities. We conducted a comprehensive systematic review and meta-analysis
of papers which reported the outcomes of osteosarcoma patients with
and without a pathological fracture. There were eight eligible papers
for final analysis which reported on 1713 patients, of whom 303
(17.7%) had a pathological fracture. The mean age for 1464 patients in
six studies was 23.2 years old (2 to 82). The mean follow-up for
1481 patients in seven studies was 90.1 months (6 to 240). The pooled estimates of local recurrence rates in osteosarcoma
patients with and without pathological fractures were 14.4% (8.7
to 20.0) The development of a pathological fracture is a negative prognostic
indicator in osteosarcoma and is associated with a reduced five-year
event-free survival and a possibly higher rate of local recurrence.
Our findings suggest that there is no absolute indication for amputation,
as similar rates of local recurrence can be achieved in patients
who are carefully selected for limb salvage. Cite this article:
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:
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:
Data on early morbidity and complications after
revision total hip replacement (THR) are limited. The aim of this nationwide
study was to describe and quantify early morbidity after aseptic
revision THR and relate the morbidity to the extent of the revision
surgical procedure. We analysed all aseptic revision THRs from 1st
October 2009 to 30th September 2011 using the Danish National Patient
Registry, with additional information from the Danish Hip Arthroplasty
Registry. There were 1553 procedures (1490 patients) performed in
40 centres and we divided them into total revisions, acetabular
component revisions, femoral stem revisions and partial revisions.
The mean age of the patients was 70.4 years (25 to 98) and the median
hospital stay was five days (interquartile range 3 to 7). Within 90
days of surgery, the readmission rate was 18.3%, mortality rate
1.4%, re-operation rate 6.1%, dislocation rate 7.0% and infection
rate 3.0%. There were no differences in these outcomes between high-
and low-volume centres. Of all readmissions, 255 (63.9%) were due
to ‘surgical’ complications Cite this article:
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:
The incidence of clinically significant avascular
necrosis (AVN) following medial open reduction of the dislocated
hip in children with developmental dysplasia of the hip (DDH) remains
unknown. We performed a systematic review of the literature to identify
all clinical studies reporting the results of medial open reduction
surgery. A total of 14 papers reporting 734 hips met the inclusion
criteria. The mean follow-up was 10.9 years (2 to 28). The rate
of clinically significant AVN (types 2 to 4) was 20% (149/734).
From these papers 221 hips in 174 children had sufficient information
to permit more detailed analysis. The rate of AVN increased with
the length of follow-up to 24% at skeletal maturity, with type 2
AVN predominating in hips after five years’ follow-up. The presence
of AVN resulted in a higher incidence of an unsatisfactory outcome
at skeletal maturity (55% Cite this article:
We investigated whether, in the management of
stable paediatric fractures of the forearm, flexible casts that
can be removed at home are as clinically effective Cite this article:
This multicentre prospective clinical trial aimed
to determine whether early administration of alendronate (ALN) delays
fracture healing after surgical treatment of fractures of the distal
radius. The study population comprised 80 patients (four men and
76 women) with a mean age of 70 years (52 to 86) with acute fragility
fractures of the distal radius requiring open reduction and internal
fixation with a volar locking plate and screws. Two groups of 40 patients
each were randomly allocated either to receive once weekly oral
ALN administration (35 mg) within a few days after surgery and continued
for six months, or oral ALN administration delayed until four months
after surgery. Postero-anterior and lateral radiographs of the affected
wrist were taken monthly for six months after surgery. No differences
between groups was observed with regard to gender (p = 1.0), age
(p = 0.916), fracture classification (p = 0.274) or bone mineral
density measured at the spine (p = 0.714). The radiographs were
assessed by three independent assessors. There were no significant
differences in the mean time to complete cortical bridging observed
between the ALN group (3.5 months ( Cite this article:
We report a systematic review and meta-analysis of published randomised controlled trials evaluating the efficacy of tranexamic acid (TXA) in reducing blood loss and transfusion in total hip replacement (THR). The data were evaluated using the generic evaluation tool designed by the Cochrane Bone, Joint and Muscle Trauma Group. We identified 11 clinical trials which were suitable for detailed extraction of data. There were no trials that used TXA in revision THR. A total of seven studies (comprising 350 patients) were eligible for the blood loss outcome data. The use of TXA reduced intra-operative blood loss by a mean of 104 ml (95% confidence interval (CI) −164 to −44, p = 0.0006, heterogeneity I2 0%), postoperative blood loss by a mean of 172 ml (95% CI −263 to −81, p = 0.0002, heterogeneity I2 63%) and total blood loss by a mean of 289 ml (95% CI −440 to −138, p <
0.0002, heterogeneity I2 54%). TXA led to a significant reduction in the proportion of patients requiring allogeneic blood transfusion (risk difference −0.20, 95% CI −0.29 to −0.11, p <
0.00001, I2 15%). There were no significant differences in deep-vein thrombosis, pulmonary embolism, infection rates or other complications among the study groups.
Dysphagia is a common complication of anterior
surgery of the cervical spine. The incidence of post-operative dysphagia
may be as high as 71% within the first two weeks after surgery,
but gradually decreases during the following months. However, 12%
to 14% of patients may have some persistent dysphagia one year after
the procedure. It has been shown that female gender, advanced age,
multilevel surgery, longer operating time and severe pre-operative
neck pain may be risk factors. Although the aetiology remains unclear
and is probably multifactorial, proposed causes include oesophageal
retraction, prominence of the cervical plate and prevertebral swelling.
Recently, pre-operative tracheal traction exercises and the use
of retropharyngeal steroids have been proposed as methods of reducing
post-operative dysphagia. We performed a systematic review to assess the incidence, aetiology,
risk factors, methods of assessment and management of dysphagia
following anterior cervical spinal surgery. Cite this article:
In Canada, Dupuytren's contracture is managed
with partial fasciectomy or percutaneous needle aponeurotomy (PNA).
Injectable collagenase will soon be available. The optimal management
of Dupuytren’s contracture is controversial and trade-offs exist
between the different methods. Using a cost-utility analysis approach,
our aim was to identify the most cost-effective form of treatment
for managing Dupuytren’s contracture it and the threshold at which
collagenase is cost-effective. We developed an expected-value decision
analysis model for Dupuytren’s contracture affecting a single finger,
comparing the cost-effectiveness of fasciectomy, aponeurotomy and collagenase
from a societal perspective. Cost-effectiveness, one-way sensitivity
and variability analyses were performed using standard thresholds
for cost effective treatment ($50 000 to $100 000/QALY gained).
Percutaneous needle aponeurotomy was the preferred strategy for
managing contractures affecting a single finger. The cost-effectiveness
of primary aponeurotomy improved when repeated to treat recurrence.
Fasciectomy was not cost-effective. Collagenase was cost-effective
relative to and preferred over aponeurotomy at $875 and $470 per
course of treatment, respectively. In summary, our model supports the trend towards non-surgical
interventions for managing Dupuytren’s contracture affecting a single
finger. Injectable collagenase will only be feasible in our publicly
funded healthcare system if it costs significantly less than current
United States pricing. Cite this article: