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 rate of surgical site infection after elective
foot and ankle surgery is higher than that after other elective orthopaedic
procedures. Since December 2005, we have prospectively collected data on
the rate of post-operative infection for 1737 patients who have
undergone elective foot and ankle surgery. In March 2008, additional
infection control policies, focused on surgical and environmental
risk factors, were introduced in our department. We saw a 50% reduction in the rate of surgical site infection
after the introduction of these measures. We are, however, aware
that the observed decrease may not be entirely attributable to these
measures alone given the number of factors that predispose to post-operative
wound infection. Cite this article:
The need to demonstrate probity and fair market competition has increased scrutiny of the relationships between orthopaedic surgeons and the industry that supplies them with their tools and devices. Investigations and judgements from the US Department of Justice and the introduction of the AdvaMed and Eucomed codes have defined new boundaries for interactions between these groups. This article summarises the current interplay between orthopaedic surgeons and industry, and provides recommendations for the future.
Our aim was to compare the outcome of arthroscopic
release for frozen shoulder in patients with and without diabetes.
We prospectively compared the outcome in 21 patients with and 21
patients without diabetes, two years post-operatively. The modified
Constant score was used as the outcome measure. The mean age of
the patients was 54.5 years (48 to 65; male:female ratio: 18:24),
the mean pre-operative duration of symptoms was 8.3 months (6 to
13) and the mean pre-operative modified Constant scores were 36.6
(standard deviation ( Cite this article:
We present the validation of a translation into
Danish of the Oxford ankle foot questionnaire (OxAFQ). We followed the
Isis Pros guidelines for translation and pilot-tested the questionnaire
on ten children and their parents. Following modifications we tested
the validity of the final questionnaire on 82 children (36 boys
and 45 girls) with a mean age of 11.7 years (5.5 to 16.0) and their
parents. We tested the reliability (repeatability (test–retest),
child–parent agreement, internal consistency), feasibility (response
rate, time to completion, floor and ceiling effects) and construct
validity. The generic child health questionnaire was used for comparison.
We found good internal consistency for the physical and the school
and play domains, but lower internal consistency for the emotional domain.
Overall, good repeatability was found within children and parents
as well as agreement between children and parents. The OxAFQ was
fast and easy to complete, but we observed a tendency towards ceiling
effects in the school and play and emotional domains. To our knowledge
this is the first independent validation of the OxAFQ in any language.
We found it valid and feasible for use in the clinic to assess the
impact on children’s lives of foot and/or ankle disorders. It is
a valuable research tool. Cite this article:
Congenital Talipes Equinovarus (CTEV) is one
of the most common congenital limb deformities. We reviewed the records
of infants who had received treatment for structural CTEV between
1 January 2007 and 30 November 2012. This was cross-referenced with
the prenatal scans of mothers over a corresponding period of time.
We investigated the sensitivity, specificity, and positive and negative
predictive values of the fetal anomaly scan for the detection of CTEV
and explored whether the publication of Fetal Anomaly Screening
Programme guidelines in 2010 affected the rate of detection. During the study period there were 95 532 prenatal scans and
34 373 live births at our hospital. A total of 37 fetuses with findings
suggestive of CTEV were included in the study, of whom 30 were found
to have structural CTEV at birth. The sensitivity of screening for
CTEV was 71.4% and the positive predictive value was 81.1%. The negative
predictive value and specificity were more than 99.5%. There was
no significant difference between the rates of detection before
and after publication of the guidelines (p = 0.5). We conclude that a prenatal fetal anomaly ultrasound screening
diagnosis of CTEV has a good positive predictive value enabling
prenatal counselling. The change in screening guidance has not affected
the proportion of missed cases. This information will aid counselling
parents about the effectiveness and accuracy of prenatal ultrasound
in diagnosing CTEV. Cite this article:
In the absence of patellar resurfacing, we have
previously shown that the use of electrocautery around the margin of
the patella improved the one-year clinical outcome of total knee
replacement (TKR). In this prospective randomised study we compared
the mean 3.7 year (1.1 to 4.2) clinical outcomes of 300 TKRs performed
with and without electrocautery of the patellar rim: this is an
update of a previous report. The overall prevalence of anterior knee
pain was 32% (95% confidence intervals [CI] 26 to 39), and 26% (95%
CI 18 to 35) in the intervention group compared with 38% (95% CI
29 to 48) in the control group (chi-squared test; p = 0.06). The
overall prevalence of anterior knee pain remained unchanged between
the one-year and 3.7 year follow-up (chi-squared test; p = 0.12). The
mean total Western Ontario McMasters Universities Osteoarthritis
Indices and the American Knee Society knee and function scores at
3.7 years’ follow-up were similar in the intervention and control
groups (repeated measures analysis of variance p = 0.43, p = 0.09
and p = 0.59, respectively). There were no complications. A total
of ten patients (intervention group three, control group seven)
required secondary patellar resurfacing after the first year. Our study suggests that the improved clinical outcome with electrocautery
denervation compared with no electrocautery is not maintained at
a mean of 3.7 years’ follow-up. Cite this article:
We evaluated the quality of guidelines on thromboprophylaxis
in orthopaedic surgery by examining how they adhere to validated
methodological standards in their development. A structured review
was performed for guidelines that were published between January
2005 and April 2013 in medical journals or on the Internet. A pre-defined
computerised search was used in MEDLINE, Scopus and Google to identify
the guidelines. The AGREE II assessment tool was used to evaluate
the quality of the guidelines in the study. Seven international and national guidelines were identified.
The overall methodological quality of the individual guidelines
was good. ‘Scope and Purpose’ (median score 98% interquartile range
(IQR)) 86% to 98%) and ‘Clarity of Presentation’ (median score 90%,
IQR 90% to 95%) were the two domains that received the highest scores. ‘Applicability’
(median score 68%, IQR 45% to 75%) and ‘Editorial Independence’
(median score 71%, IQR 68% to 75%) had the lowest scores. These findings reveal that although the overall methodological
quality of guidelines on thromboprophylaxis in orthopaedic surgery
is good, domains within their development, such as ‘Applicability’
and ‘Editorial Independence’, need to be improved. Application of
the AGREE II instrument by the authors of guidelines may improve
the quality of future guidelines and provide increased focus on
aspects of methodology used in their development that are not robust. Cite this article: Bone Joint J 2014;96-B:19–23.
This year is the centenary of the birth of John Charnley. Some of his legacy to Orthopaedic Surgery is described in this editorial.
The efficacy of circumpatellar electrocautery in reducing the incidence of post-operative anterior knee pain is unknown. We conducted a single-centre, outcome-assessor and patient-blinded, parallel-group, randomised, controlled trial to compare circumpatellar electrocautery with no electrocautery in total knee replacement in the absence of patellar resurfacing. Patients requiring knee replacement for primary osteoarthritis were randomly assigned circumpatellar electrocautery (intervention group) or no electrocautery (control group). The primary outcome measure was the incidence of anterior knee pain. A secondary measure was the standardised clinical and patient-reported outcomes determined by the American Knee Society scores and the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. A total of 131 knees received circumpatellar electrocautery and 131 had no electrocautery. The overall incidence of anterior knee pain at follow-up at one year was 26% (20% to 31%), with 19% (12% to 26%) in the intervention group and 32% (24% to 40%) in the control group (p = 0.02). The relative risk reduction from electrocautery was 40% (9% to 61%) and the number needed to treat was 7.7 (4.3 to 41.4). The intervention group had a better mean total WOMAC score at follow-up at one year compared with the control group (16.3 (0 to 77.7) Our study suggests that in the absence of patellar resurfacing electrocautery around the margin of the patella improves the outcome of total knee replacement.
Thromboprophylaxis remains a controversial subject. A vast amount of epidemiological and trial data about venous thromboembolism has been published over the past 40 years. These data have been distilled and synthesised into guidelines designed to help the practitioner translate this extensive research into ‘evidence-based’ advice. Guidelines should, in theory, benefit patient care by ensuring that every patient routinely receives the best prophylaxis; without guidelines, it is argued, patients may fail to receive treatment or be exposed to protocols which are ineffective, dangerous or expensive. Guidelines, however, have not been welcomed or applied universally. In the United States, orthopaedic surgeons have published their concerns about the thromboprophylaxis guidelines prepared by the American College of Chest Physicians. In Britain, controversy persists with many surgeons unconvinced of the risk/benefit, cost/benefit or practicality of thromboprophylaxis. The extended remit of the recent National Institute of Clinical Excellence thromboprophylaxis guidelines has been challenged. The reasons for this disquiet are addressed in this paper and particular emphasis is placed on how clinically-acceptable guidelines could be developed and applied.