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:
The aim of this study was to review the role
of clinical trial networks in orthopaedic surgery. A total of two
electronic databases (MEDLINE and EMBASE) were searched from inception
to September 2013 with no language restrictions. Articles related
to randomised controlled trials (RCTs), research networks and orthopaedic
research, were identified and reviewed. The usefulness of trainee-led
research collaborations is reported and our knowledge of current
clinical trial infrastructure further supplements the review. Searching
yielded 818 titles and abstracts, of which 12 were suitable for
this review. Results are summarised and presented narratively under
the following headings: 1) identifying clinically relevant research
questions; 2) education and training; 3) conduct of multicentre
RCTs and 4) dissemination and adoption of trial results. This review
confirms growing international awareness of the important role research
networks play in supporting trials in orthopaedic surgery. Multidisciplinary
collaboration and adequate investment in trial infrastructure are crucial
for successful delivery of RCTs. Cite this article:
In this study we evaluated the results of midtarsal
release and open reduction for the treatment of children with convex
congenital foot (CCF) (vertical talus) and compared them with the
published results of peritalar release. Between 1977 and 2009, a
total of 22 children (31 feet) underwent this procedure. In 15 children
(48%) the CCF was isolated and in the remainder it was not (seven
with arthrogryposis, two with spinal dysraphism, one with a polymalformative
syndrome and six with an undefined neurological disorder). Pre-operatively, the mean tibiotalar angle was 150.2° (106° to
175°) and the mean calcaneal pitch angle was -19.3° (-72° to 4°).
The procedure included talonavicular and calcaneocuboid joint capsulotomies,
lengthening of tendons of tibialis anterior and the extensors of
the toes, allowing reduction of the midtarsal joints. Lengthening
of the Achilles tendon was necessary in 23 feet (74%). The mean follow-up was 11 years (2 to 21). The results, as assessed
by the Adelaar score, were good in 24 feet (77.4%), fair in six
(19.3%) and poor in one foot (3.3%), with no difference between
those with isolated CCF and those without. The mean American Orthopaedic
Foot and Ankle Society midfoot score was 89.9 (54 to 100) and 77.8
(36 to 93) for those with isolated CCF and those without, respectively.
At the final follow-up, the mean tibiotalar (120°; 90 to 152) and
calcaneal pitch angles (4°; -13 to 22) had improved significantly
(p <
0.0001). Dislocation of the talonavicular and calcaneocuboid
joints was completely reduced in 22 (70.9%) and 29 (93.6%) of feet,
respectively. Three children (five feet) underwent further surgery
at a mean of 8.5 years post-operatively, three with pes planovalgus
and two in whom the deformity had been undercorrected. No child
developed avascular necrosis of the talus. Midtarsal joint release and open reduction is a satisfactory
procedure, which may provide better results than peritalar release.
Complications include the development of pes planovalgus and persistent
dorsal subluxation of the talonavicular joint. Cite this article:
The February 2014 Shoulder &
Elbow Roundup360 looks at: whether arthroscopic acromioplasty is a cost-effective intervention; shockwave therapy in cuff tear; whether microfracture relieves short-term pain in cuff repair; the promising early results from L-PRF augmented cuff repairs; rehabilitation following cuff repair; supination strength following biceps tendon rupture; whether longer is better in humeral components; fatty degeneration in a rodent model; and the controversial acromioclavicular joint dislocation.
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 December 2013 Wrist &
Hand Roundup360 looks at: Scapholunate instability; three-ligament tenodesis; Pronator quadratus; Proximal row carpectomy; FPL dysfunction after volar plate fixation; Locating the thenar branch of the median nerve; Metallosis CMCJ arthroplasties; and timing of flap reconstruction
The February 2014 Knee Roundup360 looks at: whether sham surgery is as good as arthroscopic meniscectomy; distraction in knee osteoarthritis; whether trans-tibial tunnel placement increases the risk of graft failure in ACL surgery; whether joint replacements prevent cardiac events; the size of the pulmonary embolism problem; tranexamic acid and knee replacement haemostasis; matching the demand for knee replacement and follow-up; predicting the length of stay after knee replacement; and popliteal artery injury in TKR.
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. 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.Objectives
Methods
We performed A total of 12 cadaveric lower limbs were tested with a commercial
image-free navigation system using trackers secured by bone screws.
We then tested a non-invasive fabric-strap system. The lower limb
was secured at 10° intervals from 0° to 60° of knee flexion and
100 N of force was applied perpendicular to the tibia. Acceptable
coefficient of repeatability (CR) and limits of agreement (LOA)
of 3 mm were set based on diagnostic criteria for anterior cruciate
ligament (ACL) insufficiency.Objectives
Methods
The February 2014 Research Roundup360 looks at: blood supply to the femoral head after dislocation; diabetes and hip replacement; bone remodelling over two decades following hip replacement; sham surgery as good as arthroscopic meniscectomy; distraction in knee osteoarthritis; whether joint replacement prevent cardiac events; tranexamic acid and knee replacement haemostasis; cartilage colonisation in bipolar ankle grafts; CTs and proof of fusion; atorvastatin for muscle re-innervation after sciatic nerve transection; microfracture and short-term pain in cuff repair; promising early results from L-PRF augmented cuff repairs; and fatty degeneration in a rodent model.
The National Institute for Health and Clinical
Excellence (NICE) guidelines from 2011 recommend the use of cemented
hemi-arthroplasty for appropriate patients with an intracapsular
hip fracture. In our institution all patients who were admitted
with an intracapsular hip fracture and were suitable for a hemi-arthroplasty
between April 2010 and July 2012 received an uncemented prosthesis
according to our established departmental routine practice. A retrospective
analysis of outcome was performed to establish whether the continued
use of an uncemented stem was justified. Patient, surgical and outcome
data were collected on the National Hip Fracture database. A total
of 306 patients received a Cathcart modular head on a Corail uncemented
stem as a hemi-arthroplasty. The mean age of the patients was 83.3
years ( Cite this article:
The purpose of this study was to identify changing
trends in the pattern of distribution of the type and demographics
of fractures of the hip in the elderly between 2001 and 2010. A
retrospective cross-sectional comparison was conducted between 179
fractures of the hip treated in 2001, 357 treated in 2006 and 454
treated in 2010. Patients aged <
60 years and those with pathological
and peri-prosthetic fractures were excluded. Fractures were classified
as stable extracapsular, unstable extracapsular or intracapsular
fractures. The mean age of the 179 patients (132 women (73.7%)) treated
in 2001 was 80.8 years (60 to 96), 81.8 years (61 to 101) in the
357 patients (251 women (70.3%)) treated in 2006 and 82.0 years
(61 to 102) in the 454 patients (321 women (70.1%)) treated in 2010
(p = 0.17). There was no difference in the gender distribution between
the three study years (p = 0.68). The main finding was a steep rise in the proportion of unstable
peritrochanteric fractures. The proportion of unstable extracapsular
fractures was 32% (n = 57) in 2001, 35% (n = 125) in 2006 and 45%
(n = 204) in 2010 (p <
0.001). This increase was not significant
in patients aged between 60 and 69 years (p = 0.84), marginally
significant in those aged between 70 and 79 years (p = 0.04) and
very significant in those aged >
80 years (p <
0.001). The proportion
of intracapsular fractures did not change (p = 0.94). At present, we face not only an increasing number of fractures
of the hip, but more demanding and complex fractures in older patients
than a decade ago. This study does not provide an explanation for
this change. Cite this article:
Traumatic brachial plexus injury causes severe functional impairment
of the arm. Elbow flexion is often affected. Nerve surgery or tendon
transfers provide the only means to obtain improved elbow flexion.
Unfortunately, the functionality of the arm often remains insufficient.
Stem cell therapy could potentially improve muscle strength and
avoid muscle-tendon transfer. This pilot study assesses the safety
and regenerative potential of autologous bone marrow-derived mononuclear
cell injection in partially denervated biceps. Nine brachial plexus patients with insufficient elbow flexion
(i.e., partial denervation) received intramuscular escalating doses
of autologous bone marrow-derived mononuclear cells, combined with
tendon transfers. Effect parameters included biceps biopsies, motor
unit analysis on needle electromyography and computerised muscle tomography,
before and after cell therapy.Objectives
Methods
The aim of this study was to define the incidence
of venous thromboembolism (VTE) and risk factors for the development
of deep-vein thrombosis (DVT) after the resection of a musculoskeletal
tumour. A total of 94 patients who underwent resection of a musculoskeletal
tumour between January 2003 and December 2005 were prospectively
studied. There were 42 men and 52 women with a mean age of 54.4
years (18 to 86). All patients wore intermittent pneumatic compression
devices and graduated compression stockings. Ultrasound examination
of the lower limbs was conducted to screen for DVT between the fifth
and ninth post-operative days. DVT was detected in 21 patients (22%). Of these, two were symptomatic
(2%). One patient (1%) had a fatal pulmonary embolism. Patients
aged ≥ 70 years had an increased risk of DVT (p = 0.004). The overall incidence of DVT (both symptomatic and asymptomatic)
after resection of a musculoskeletal tumour with mechanical prophylaxis
was high. It seems that both mechanical and anticoagulant prophylaxis
is needed to prevent VTE in patients who have undergone the resection
of a musculoskeletal tumour. Cite this article:
Although it has been suggested that the outcome
after revision of a unicondylar knee replacement (UKR) to total knee
replacement (TKR) is better when the mechanism of failure is understood,
a comparative study on this subject has not been undertaken. A total of 30 patients (30 knees) who underwent revision of their
unsatisfactory UKR to TKR were included in the study: 15 patients
with unexplained pain comprised group A and 15 patients with a defined
cause for pain formed group B. The Oxford knee score (OKS), visual
analogue scale for pain (VAS) and patient satisfaction were assessed before
revision and at one year after revision, and compared between the
groups. The mean OKS improved from 19 (10 to 30) to 25 (11 to 41) in
group A and from 23 (11 to 45) to 38 (20 to 48) in group B. The
mean VAS improved from 7.7 (5 to 10) to 5.4 (1 to 8) in group A
and from 7.4 (2 to 9) to 1.7 (0 to 8) in group B. There was a statistically
significant difference between the mean improvements in each group
for both OKS (p = 0.022) and VAS (p = 0.002). Subgroup analysis
in group A, performed in order to define a patient factor that predicts
outcome of revision surgery in patients with unexplained pain, showed
no pre-operative differences between both subgroups. These results may be used to inform patients about what to expect
from revision surgery, highlighting that revision of UKR to TKR
for unexplained pain generally results in a less favourable outcome
than revision for a known cause of pain. Cite this article:
Nonunion is one of the most troublesome complications to treat
in orthopaedics. Former authors believed that atrophic nonunion
occurred as a result of lack of mesenchymal stem cells (MSCs). We
evaluated the number and viability of MSCs in site of atrophic nonunion compared
with those in iliac crest. We enrolled five patients with neglected atrophic nonunions of
long bones confirmed by clinical examinations and plain radiographs
into this study. As much as 10 ml bone marrow aspirate was obtained
from both the nonunion site and the iliac crest and cultured for
three weeks. Cell numbers were counted using a haemocytometer and
vitality of the cells was determined by trypan blue staining. The
cells were confirmed as MSCs by evaluating their expression marker
(CD 105, CD 73, HLA-DR, CD 34, CD 45, CD 14, and CD 19). Cells number and
viability were compared between the nonunion and iliac creat sites.Objectives
Methods
We hypothesised that a large acromial cover with
an upwardly tilted glenoid fossa would be associated with degenerative
rotator cuff tears (RCTs), and conversely, that a short acromion
with an inferiorly inclined glenoid would be associated with glenohumeral
osteoarthritis (OA). This hypothesis was tested using a new radiological parameter,
the critical shoulder angle (CSA), which combines the measurements
of inclination of the glenoid and the lateral extension of the acromion
(the acromion index). The CSA was measured on standardised radiographs of three groups:
1) a control group of 94 asymptomatic shoulders with normal rotator
cuffs and no OA; 2) a group of 102 shoulders with MRI-documented
full-thickness RCTs without OA; and 3) a group of 102 shoulders
with primary OA and no RCTs noted during total shoulder replacement.
The mean CSA was 33.1° (26.8° to 38.6°) in the control group, 38.0°
(29.5° to 43.5°) in the RCT group and 28.1° (18.6° to 35.8°) in
the OA group. Of patients with a CSA >
35°, 84% were in the RCT
group and of those with a CSA <
30°, 93% were in the OA group. We therefore concluded that primary glenohumeral OA is associated
with significantly smaller degenerative RCTs with significantly
larger CSAs than asymptomatic shoulders without these pathologies.
These findings suggest that individual quantitative anatomy may
imply biomechanics that are likely to induce specific types of degenerative
joint disorders. Cite this article:
The aim of this study was to evaluate whether
coating titanium discs with selenium in the form of sodium selenite decreased
bacterial adhesion of In order to evaluate bacterial adhesion, sterile titanium discs
were coated with increasing concentrations of selenium and incubated
with bacterial solutions of The tested Selenium coating is a promising method to reduce bacterial attachment
on prosthetic material. Cite this article:
The purpose of this study was twofold: first,
to determine whether the five-year results of hip resurfacing arthroplasty
(HRA) in Canada justified the continued use of HRA; and second,
to identify whether greater refinement of patient selection was
warranted. This was a retrospective cohort study that involved a review
of 2773 HRAs performed between January 2001 and December 2008 at
11 Canadian centres. Cox’s proportional hazards models were used
to analyse the predictors of failure of HRA. Kaplan–Meier survival
analysis was performed to predict the cumulative survival rate at
five years. The factors analysed included age, gender, body mass
index, pre-operative hip pathology, surgeon’s experience, surgical
approach, implant sizes and implant types. The most common modes
of failure were also analysed. The 2773 HRAs were undertaken in 2450 patients: 2127 in men and
646 in women. The mean age at operation was 50.5 years ( The failure rates of HRA at five years justify the ongoing use
of this technique in men. Female gender is an independent predictor
of failure, and a higher failure rate at five years in women leads
the authors to recommend this technique only in exceptional circumstances
for women. Cite this article:
Recent guidance recommends the use of a well-proven
cemented femoral stem for hemiarthroplasty in the management of
fractures of the femoral neck, and the Exeter Trauma Stem (ETS)
has been suggested as an example of such an implant. The design
of this stem was based on the well-proven Exeter Total Hip Replacement
stem (ETHRS). This study assessed the surface finish of the ETS
in comparison with the ETHRS. Two ETSs and two ETHRSs were examined
using a profilometer with a precision of 1 nm and compared with
an explanted Exeter Matt stem. The mean roughness average (RA) of
the ETSs was approximately ten times higher than that of the ETHRSs (0.235 μm
(0.095 to 0.452) Cite this article: