We conducted a randomised controlled trial to assess the accuracy
of positioning and alignment of the components in total knee arthroplasty
(TKA), comparing those undertaken using standard intramedullary
cutting jigs and those with patient-specific instruments (PSI). There were 64 TKAs in the standard group and 69 in the PSI group. The post-operative hip-knee-ankle (HKA) angle and positioning
was investigated using CT scans. Deviation of >
3° from the planned
position was regarded as an outlier. The operating time, Oxford
Knee Scores (OKS) and Short Form-12 (SF-12) scores were recorded.Aims
Patients and Methods
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. 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.Background
Design
Wound complications are reported in up to 10% hip and knee arthroplasties and there is a proven association between wound complications and deep prosthetic infections. In this randomised controlled trial (RCT) we explore the potential benefits of a portable, single use, incisional negative pressure wound therapy dressing (iNPWTd) on wound exudate, length of stay (LOS), wound complications, dressing changes and cost-effectiveness following total hip and knee arthroplasties. A total of 220 patients undergoing elective primary total hip and knee arthroplasties were recruited into in a non-blinded RCT. For the final analysis there were 102 patients in the study group and 107 in the control group.Objectives
Methods
We performed a systematic review of the literature to determine the safety and efficacy of bone morphogenetic protein (BMP) compared with bone graft when used specifically for revision spinal fusion surgery secondary to pseudarthrosis. The MEDLINE, EMBASE and Cochrane Library databases were searched using defined search terms. The primary outcome measure was spinal fusion, assessed as success or failure in accordance with radiograph, MRI or CT scan review at 24-month follow-up. The secondary outcome measure was time to fusion.Objectives
Methods
The aim of this study was to compare the effectiveness of a femoral
nerve block and a periarticular infiltration in the management of
early post-operative pain after total knee arthroplasty (TKA). A pragmatic, single centre, two arm parallel group, patient blinded,
randomised controlled trial was undertaken. All patients due for
TKA were eligible. Exclusion criteria included contraindications
to the medications involved in the study and patients with a neurological
abnormality of the lower limb. Patients received either a femoral
nerve block with 75 mg of 0.25% levobupivacaine hydrochloride around
the nerve, or periarticular infiltration with 150 mg of 0.25% levobupivacaine
hydrochloride, 10 mg morphine sulphate, 30 mg ketorolac trometamol
and 0.25 mg of adrenaline all diluted with 0.9% saline to make a
volume of 150 ml.Aims
Patients and Methods
Our aim was to prepare a systematic review and meta-analysis
to compare the outcomes of cemented and cementless hemiarthroplasty
of the hip, in elderly patients with a fracture of the femoral neck,
to investigate the mortality, complications, length of stay in hospital,
blood loss, operating time and functional results. A systematic review and meta-analysis was conducted following
the Preferred Reporting Items for Systematic Reviews and Meta-Analyses
guidelines on randomised controlled trials (RCTs), studying current
generation designs of stem only. The synthesis of results was done
of pooled data, with a fixed effects or random effects model, based on
heterogeneity.Aims
Materials and Methods
There are two techniques widely used to determine the rotational
alignment of the components in total knee arthroplasty (TKA); gap
balancing (GB) and measured resection (MR). Which technique is the
best remains controversial. We aimed to investigate this in a systematic
review and meta-analysis. In accordance with the methods of Cochrane, databases were searched
for all randomised controlled trials in the literature between January
1986 and June 2015 comparing radiographic and clinical outcomes
between the use of these two tecniques. Meta-analysis involved the
use of the Revman5.3 software provided by Cochrane collaboration.Aims
Materials and Methods
Hip fracture is a common injury associated with
high mortality, long-term disability and huge socio-economic burden.
Yet there has been relatively little research into best treatment,
and evidence that has been generated has often been criticised for
its poor quality. Here, we discuss the advances made towards overcoming
these criticisms and the future directions for hip fracture research:
how co-ordinating existing national infrastructures and use of now
established clinical research networks will likely go some way towards
overcoming the practical and financial challenges of conducting
large trials. We highlight the importance of large collaborative
pragmatic trials to inform decision/policy makers and the progress
made towards reaching a consensus on a core outcome set to facilitate data
pooling for evidence synthesis and meta-analysis. These advances and future directions are a priority in order
to establish the high-quality evidence base required for this important
group of patients. Cite this article:
Our purpose was to determine the quality of current randomised
controlled trials (RCTs) in hand surgery using standardised metrics. Based on five-year mean impact factors, we selected the six journals
that routinely publish studies of upper extremity surgery. Using
a journal-specific search query, 62 RCTs met our inclusion criteria.
Then three blinded reviewers used the Jadad and revised Coleman Methodology
Score (RCMS) to assess the quality of the manuscripts.Aims
Materials and Methods
The PROximal Fracture of the Humerus Evaluation by Randomisation
(PROFHER) randomised clinical trial compared the operative and non-operative
treatment of adults with a displaced fracture of the proximal humerus
involving the surgical neck. The aim of this study was to determine
the long-term treatment effects beyond the two-year follow-up. Of the original 250 trial participants, 176 consented to extended
follow-up and were sent postal questionnaires at three, four and
five years after recruitment to the trial. The Oxford Shoulder Score
(OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent
shoulder operations and fracture data were collected. Statistical
and economic analyses, consistent with those of the main trial were
applied.Aims
Patients and Methods
The increased The proximal penetration of the femoral head five years post-operatively
was measured for 15 patients using radiostereometric analysis (RSA).Aims
Patients and Methods
We report a systematic review and meta-analysis
of published randomised and quasi-randomised trials evaluating the
efficacy of pre-operative skin antisepsis and cleansing techniques
in reducing foot and ankle skin flora. The post-preparation culture
number (Post-PCN) was the primary outcome. The data were evaluated
using a modified version of the Cochrane Collaboration’s tool. We
identified eight trials (560 participants, 716 feet) that met the inclusion
criteria. There was a significant difference in the proportions
of Post-PCN between hallux nailfold (HNF) and toe web spaces (TWS)
sites: 0.47 Meta-analyses showed that alcoholic chlorhexidine had better
efficacy than alcoholic povidone-iodine (PI) at HNF sites (risk
difference 0.19 (95% CI 0.08 to 0.30); p = 0.0005); a two-step intervention
using PI scrub and paint (S&
P) followed by alcohol showed significantly
better efficacy over PI (S&
P) alone at TWS sites (risk difference
0.13 (95% CI 0.02 to 0.24); p = 0.0169); and a two-step intervention
using chlorhexidine scrub followed by alcohol showed significantly
better efficacy over PI (S&
P) alone at the combined (HNF with
TWS) sites (risk difference 0.27 (95% CI 0.13 to 0.40); p <
0.0001).
No significant difference was found between cleansing techniques. 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:
We conducted a systematic review and meta-analysis
of randomised controlled trials evaluating the effect of tranexamic
acid (TXA) upon blood loss and transfusion in primary total knee
replacement. The review used the generic evaluation tool designed
by the Cochrane Bone, Joint and Muscle Trauma Group. A total of
19 trials were eligible: 18 used intravenous administration, one
also evaluated oral dosing and one trial evaluated topical use.
TXA led to a significant reduction in the proportion of patients
requiring blood transfusion (risk ratio (RR) 2.56, 95% confidence
interval (CI) 2.1 to 3.1, p <
0.001; heterogeneity I2 =
75%; 14 trials, 824 patients). Using TXA also reduced total blood
loss by a mean of 591 ml (95% CI 536 to 647, p <
0.001; I2 =
78%; nine trials, 763 patients). The clinical interpretation of
these findings is limited by substantial heterogeneity. However,
subgroup analysis of high-dose (>
4 g) TXA showed a plausible consistent
reduction in blood transfusion requirements (RR 5.33; 95% CI 2.44
to 11.65, p <
0.001; I2 = 0%), a finding that should
be confirmed by a further well-designed trial. The current evidence
from trials does not support an increased risk of deep-vein thrombosis
(13 trials, 801 patients) or pulmonary embolism (18 trials, 971
patients) due to TXA administration.
Our aim was to perform a systematic review of the literature
to assess the incidence of post-operative epidural haematomas and
wound infections after one-, or two-level, non-complex, lumbar surgery
for degenerative disease in patients with, or without post-operative
wound drainage. Studies were identified from PubMed and EMBASE, up to and including
27 August 2015, for papers describing one- or two-level lumbar discectomy
and/or laminectomy for degenerative disease in adults which reported
any form of subcutaneous or subfascial drainage.Aims
Patients and Methods
Our aim was to compare kinematic with mechanical alignment in
total knee arthroplasty (TKA). We performed a prospective blinded randomised controlled trial
to compare the functional outcome of patients undergoing TKA in
mechanical alignment (MA) with those in kinematic alignment (KA).
A total of 71 patients undergoing TKA were randomised to either
kinematic (n = 36) or mechanical alignment (n = 35). Pre- and post-operative
hip-knee-ankle radiographs were analysed. The knee injury and osteoarthritis
outcome score (KOOS), American Knee Society Score, Short Form-36,
Euro-Qol (EQ-5D), range of movement (ROM), two minute walk, and timed
up and go tests were assessed pre-operatively and at six weeks,
three and six months and one year post-operatively.Aims
Patients and Methods
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. 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.Objectives
Methods
This prospective randomised controlled trial was designed to
evaluate the outcome of both the MRI- and CT-based patient-specific
matched guides (PSG) from the same manufacturer. A total of 137 knees in 137 patients (50 men, 87 women) were
included, 67 in the MRI- and 70 in the CT-based PSG group. Their
mean age was 68.4 years (47.0 to 88.9). Outcome was expressed as
the biomechanical limb alignment (centre hip-knee-ankle: HKA-axis)
achieved post-operatively, the position of the individual components
within 3° of the pre-operatively planned alignment, correct planned
implant size and operative data (e.g. operating time and blood loss).Aims
Patients and Methods
We chose unstable extra-capsular hip fractures as our study group
because these types of fractures suffer the largest blood loss.
We hypothesised that tranexamic acid (TXA) would reduce total blood
loss (TBL) in extra-capsular fractures of the hip. A single-centre placebo-controlled double-blinded randomised
clinical trial was performed to test the hypothesis on patients
undergoing surgery for extra-capsular hip fractures. For reasons
outside the control of the investigators, the trial was stopped
before reaching the 120 included patients as planned in the protocol. Aims
Patients and Methods
To examine the rates of hamstring graft salvage with arthroscopic
debridement of infected anterior cruciate ligament (ACL) reconstruction
as reported in the literature and discuss functional outcomes. A search was performed without language restriction on PubMed,
EMBASE, Ovid, CINAHL and Cochrane Register of Controlled Trials
(CENTRAL) databases from their inception to April 2015. We identified
147 infected hamstring grafts across 16 included studies. Meta-analysis
was performed using a random-effects model to estimate the overall
graft salvage rate, incorporating two different definitions of graft
salvage.Aims
Materials and Methods
