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
Osteoporosis has become an increasing concern for older people as it may potentially lead to osteoporotic fractures. This study is designed to assess the efficacy and safety of ten therapies for post-menopausal women using network meta-analysis. We conducted a systematic search in several databases, including PubMed and Embase. A random-effects model was employed and results were assessed by the odds ratio (OR) and corresponding 95% confidence intervals (CI). Furthermore, with respect to each outcome, each intervention was ranked according to the surface under the cumulative ranking curve (SUCRA) value.Objectives
Methods
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:
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
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 compare the pain caused by the application
of a tourniquet after exsanguination of the upper limb with that
occurring after simple elevation. We used 26 healthy volunteers (52 arms), each of whom acted as
their own matched control. The primary outcome measure was the total pain experienced by
each volunteer while the tourniquet was inflated for 20 minutes.
This was calculated as the area under the pain curve for each individual
subject. Secondary outcomes were pain at each time point; the total
pain experienced during the recovery phase; the ability to tolerate the
tourniquet and the time for full recovery after deflation of the
tourniquet. Aims
Patients and Methods
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. Cite this article:
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
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
Effective analgesia after total knee arthroplasty (TKA) improves
patient satisfaction, mobility and expedites discharge. This study
assessed whether continuous femoral nerve infusion (CFNI) was superior
to a single-shot femoral nerve block in primary TKA surgery completed
under subarachnoid blockade including morphine. We performed an adequately powered, prospective, randomised,
placebo-controlled trial comparing CFNI of 0.125% bupivacaine Objectives
Methods
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
There is a high rate of mortality in elderly
patients who sustain a fracture of the hip. We aimed to determine
the rate of preventable mortality and errors during the management
of these patients. A 12 month prospective study was performed on
patients aged >
65 years who had sustained a fracture of the hip.
This was conducted at a Level 1 Trauma Centre with no orthogeriatric
service. A multidisciplinary review of the medical records by four
specialists was performed to analyse errors of management and elements
of preventable mortality. During 2011, there were 437 patients aged
>
65 years admitted with a fracture of the hip (85 years (66 to
99)) and 20 died while in hospital (86.3 years (67 to 96)). A total
of 152 errors were identified in the 80 individual reviews of the
20 deaths. A total of 99 errors (65%) were thought to have at least
a moderate effect on death; 45 reviews considering death (57%) were thought
to have potentially been preventable. Agreement between the panel
of reviewers on the preventability of death was fair. A larger-scale
assessment of preventable mortality in elderly patients who sustain
a fracture of the hip is required. Multidisciplinary review panels
could be considered as part of the quality assurance process in
the management of these patients. Cite this article
The maintenance of quality and integrity in clinical
and basic science research depends upon peer review. This process
has stood the test of time and has evolved to meet increasing work
loads, and ways of detecting fraud in the scientific community.
However, in the 21st century, the emphasis on evidence-based medicine
and good science has placed pressure on the ways in which the peer
review system is used by most journals. This paper reviews the peer review system and the problems it
faces in the digital age, and proposes possible solutions. Cite this article:
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:
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:
The June 2013 Hip &
Pelvis Roundup360 looks at: failure in metal-on-metal arthroplasty; minimal hip approaches; whether bisphosphonates improve femoral bone stock following arthroplasty; whether more fat means more operative time; surgical infection; vascularised fibular graft for osteonecrosis; subclinical SUFE; and dentists, hips and antibiotics.
Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.
The purpose of this study was to compare the
outcome and complications of endoscopic We conclude that endoscopic release for de Quervain’s tenosynovitis
seems to provide earlier improvement after surgery, with fewer superficial
radial nerve complications and greater scar satisfaction, when compared
with open release. Cite this article:
The osteoinductive properties of demineralised
bone matrix have been demonstrated in animal studies. However, its therapeutic
efficacy has yet to be proven in humans. The clinical properties
of AlloMatrix, an injectable calcium-based demineralised bone matrix
allograft, were studied in a prospective randomised study of 50
patients with an isolated unstable distal radial fracture treated
by reduction and Kirschner (K-) wire fixation. A total of 24 patients
were randomised to the graft group (13 men and 11 women, mean age
42.3 years (20 to 62)) and 26 to the no graft group (8 men and 18
women, mean age 45.0 years (17 to 69)). At one, three, six and nine weeks, and six and 12 months post-operatively,
patients underwent radiological evaluation, assessments for range
of movement, grip and pinch strength, and also completed the Disabilities
of Arm, Shoulder and Hand questionnaire. At one and six weeks and
one year post-operatively, bone mineral density evaluations of both
wrists were performed. No significant difference in wrist function and speed of recovery,
rate of union, complications or bone mineral density was found between
the two groups. The operating time was significantly higher in the
graft group (p = 0.004). Radiologically, the reduction parameters
remained similar in the two groups and all AlloMatrix extraosseous leakages
disappeared after nine weeks. This prospective randomised controlled trial did not demonstrate
a beneficial effect of AlloMatrix demineralised bone matrix in the
treatment of this category of distal radial fractures treated by
K-wire fixation. Cite this article:
