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
This protocol describes a pragmatic multicentre
randomised controlled trial (RCT) to assess the clinical and cost
effectiveness of arthroscopic and open surgery in the management
of rotator cuff tears. This trial began in 2007 and was modified
in 2010, with the removal of a non-operative arm due to high rates
of early crossover to surgery. Cite this article:
The October 2015 Trauma Roundup360 looks at: PCA not the best in resuscitation; Impact of trauma centre care; Quality of life after a hip fracture; Recovery and severity of injury: open tibial fractures in the spotlight; Assessment of the triplane fractures; Signs of an unstable paediatric pelvis; Safe insertion of SI screws: are two views required?; Post-operative delirium under the spotlight; Psychological effects of fractures; K-wires cost effective in DRAFFT
Many different designs of total hip arthroplasty
(THA) with varying performance and cost are available. The identification
of those which are the most cost-effective could allow significant
cost-savings. We used an established Markov model to examine the
cost effectiveness of five frequently used categories of THA which differed
according to bearing surface and mode of fixation, using data from
the National Joint Registry for England and Wales. Kaplan–Meier
analyses of rates of revision for men and women were modelled with
parametric distributions. Costs of devices were provided by the
NHS Supply Chain and associated costs were taken from existing studies.
Lifetime costs, lifetime quality-adjusted-life-years (QALYs) and
the probability of a device being cost effective at a willingness
to pay £20 000/QALY were included in the models. The differences in QALYs between different categories of implant
were extremely small (<
0.0039 QALYs for men or women over the
patient’s lifetime) and differences in cost were also marginal (£2500
to £3000 in the same time period). As a result, the probability
of any particular device being the most cost effective was very
sensitive to small, plausible changes in quality of life estimates
and cost. Our results suggest that available evidence does not support
recommending a particular device on cost effectiveness grounds alone.
We would recommend that the choice of prosthesis should be determined
by the rate of revision, local costs and the preferences of the
surgeon and patient. Cite this article:
Subtotal or total meniscectomy in the medial or lateral compartment
of the knee results in a high risk of future osteoarthritis. Meniscal
allograft transplantation has been performed for over thirty years
with the scientifically plausible hypothesis that it functions in
a similar way to a native meniscus. It is thought that a meniscal
allograft transplant has a chondroprotective effect, reducing symptoms
and the long-term risk of osteoarthritis. However, this hypothesis has
never been tested in a high-quality study on human participants.
This study aims to address this shortfall by performing a pilot
randomised controlled trial within the context of a comprehensive
cohort study design. Patients will be randomised to receive either meniscal transplant
or a non-operative, personalised knee therapy program. MRIs will
be performed every four months for one year. The primary endpoint
is the mean change in cartilage volume in the weight-bearing area
of the knee at one year post intervention. Secondary outcome measures
include the mean change in cartilage thickness, T2 maps, patient-reported
outcome measures, health economics assessment and complications.Objectives
Methods
The results of the DRAFFT (distal radius acute
fracture fixation trial) study, which compared volar plating with
Kirschner (K-) wire fixation for dorsally displaced fractures of
the distal radius, were published in August 2014. The use of K-wires
to treat these fractures is now increasing, with a concomitant decline
in the use of volar locking plates. We provide a critical appraisal of the DRAFFT study and question
whether surgeons have been unduly influenced by its headline conclusions. Cite this article:
Our aim, using English Hospital Episode Statistics data before
during and after the Distal Radius Acute Fracture Fixation Trial
(DRAFFT), was to assess whether the results of the trial affected
clinical practice. Data were grouped into six month intervals from July 2005 to
December 2014. All patient episodes in the National Health Service
involving emergency surgery for an isolated distal radial fracture
were included.Aims
Patients and Methods
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. 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.Objectives
Methods
The National Institute for Health and Clinical
Excellence (NICE) has thus far relied on historical data and predominantly
industry-sponsored trials to provide evidence for venous thromboembolic
(VTE) prophylaxis in joint replacement patients. We argue that the
NICE guidelines may be reliant on assumptions that are in need of
revision. Following the publication of large scale, independent
observational studies showing little difference between low-molecular-weight
heparins and aspirin, and recent changes to the guidance provided
by other international bodies, should NICE reconsider their recommendations? Cite this article:
We performed a systematic review and meta-analysis
of modern total ankle replacements (TARs) to determine the survivorship,
outcome, complications, radiological findings and range of movement,
in patients with end-stage osteoarthritis (OA) of the ankle who
undergo this procedure. We used the methodology of the Cochrane Collaboration,
which uses risk of bias profiling to assess the quality of papers
in favour of a domain-based approach. Continuous outcome scores
were pooled across studies using the generic inverse variance method
and the random-effects model was used to incorporate clinical and
methodological heterogeneity. We included 58 papers (7942 TARs)
with an interobserver reliability (Kappa) for selection, performance,
attrition, detection and reporting bias of between 0.83 and 0.98.
The overall survivorship was 89% at ten years with an annual failure
rate of 1.2% (95% confidence interval (CI) 0.7 to 1.6). The mean
American Orthopaedic Foot and Ankle Society score changed from 40 (95%
CI 36 to 43) pre-operatively to 80 (95% CI 76 to 84) at a mean follow-up
of 8.2 years (7 to 10) (p <
0.01). Radiolucencies were identified
in up to 23% of TARs after a mean of 4.4 years (2.3 to 9.6). The
mean total range of movement improved from 23° (95% CI 19 to 26)
to 34° (95% CI 26 to 41) (p = 0.01). Our study demonstrates that TAR has a positive impact on patients’
lives, with benefits lasting ten years, as judged by improvement
in pain and function, as well as improved gait and increased range
of movement. However, the quality of evidence is weak and fraught
with biases and high quality randomised controlled trials are required
to compare TAR with other forms of treatment such as fusion. Cite this article:
The use of robotics in arthroplasty surgery is expanding rapidly as improvements in the technology evolve. This article examines current evidence to justify the usage of robotics, as well as the future potential in this emerging field.
The August 2015 Spine Roundup360 looks at: Steroids may be useful in avoiding dysphagia in anterior cervical discectomy and fusion (ACDF); Perhaps X-Stop ought to stop?; Is cervical plexus block in ACDF the gateway to day case spinal surgery?; Epidural past its heyday?; Steroids in lumbar back pain; Lumbar disc replacement improving; Post-discectomy arthritis
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
The February 2014 Spine Roundup360 looks at: single posterior approach for severe kyphosis; risk factors for recurrent disc herniation; dysphagia and cervical disc replacement or fusion; hang on to your topical antibiotics; cost-effective lumbar disc replacement; anxiolytics no role to play in acute lumbar back pain; and surgery best for lumbar disc herniation.
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.
