Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.Aims
Methods
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:
Accurate and reproducible radiological assessment of shoulder replacement prostheses over time is important for identifying failure or to provide reassurance. A number of clearly defined radiological parameters have been described to help standardise the radiological assessment of prostheses. To our knowledge, this is the first study conducted to test the reproducibility and reliability of these measurements. The aim of this work was to test intraobserver reproducibility and interobserver reliability in the measurement of humeral component orientation (HCO), humeral head offset (HHO), humeral head size (HHS), humeral head height (HHH), and acromiohumeral distance (AHD.)Background
Aim
A recent Cochrane review has shown that total shoulder arthroplasty (TSA) seems to offer an advantage in terms of shoulder function over hemiarthroplasty, with no other obvious clinical benefits. This is the first study to compare complication rates on a national scale. All patients (9804 patients) who underwent either TSA or shoulder hemiarthroplasty as a planned procedure between 2005 and 2008 in the English NHS were identified using the hospital episodes statistic database. Data was extracted on 30-day rates of readmission, wound complications, reoperation and medical complications (myocardial infarction (MI) and chest infection (LRTI)), and inpatient 90-day DVT, PE and mortality rates (MR). Revision rate at 18 months was analysed for the whole cohort and, for a subset of 939 patients, 5-year revision rate. Odds ratio (OR) was used to compare groups.Background
Methods
In 2011 20% of intracapsular fractured neck of femurs were treated with an uncemented hemiarthroplasty in the English NHS. National guidelines recommend cemented implants, based on evidence of less pain, better mobility and lower costs. We aimed to compare complications following cemented and uncemented hemiarthroplasty using the national hospital episode statistics (HES) database in England. Dislocation, revision, return to theatre and medical complications were extracted for all patients with NOF fracture who underwent either cemented or uncemented hemiarthroplasty between January 2005 and December 2008. To make a ‘like for like’ comparison all 30424 patients with an uncemented impant were matched to 30424 cemented implants (from a total of 42838) in terms of age, sex and Charlson co-morbidity score.Background
Methods
Prevalence of rotator cuff tears increases with advancing age (Ellman et al). In spite of proximal humeral fractures being common in the elderly, the influence of a coexistent rotator cuff tear on outcome has, to our knowledge, not been previously investigated. This study prospectively assessed whether the presence of a rotator cuff tear in association with a proximal humeral fracture influences functional prognosis. 85 patients treated conservatively for proximal humeral fractures were evaluated prospectively with Ultrasonography to determine the status of the rotator cuff. Every patient was managed by immobilisation of the arm in a sling for two weeks followed by a course of physiotherapy based on the Neer regime. Functional outcome was measured using the Constant shoulder score and the Oxford shoulder score, at 3-months and 12-months post injury. Sixty-six of the 85 patients were female. The fractures were equally distributed for hand dominance. There were 27 patients with an undisplaced fracture, 34 patients with Neer's Type II fracture and 24 patients with Neer's Type III and IV fracture. There were 43 patients with full thickness cuff tears and 42 patients with no cuff tear or a partial thickness tear. Full thickness cuff tears were much more frequent in the over 60 year age group, which is consistent with the known increased incidence of cuff tears with increasing age. The outcome scores at 3 and 12 months showed no statistically significant difference for either the Constant score or the Oxford score with regards to cuff integrity. Analysis of these scores showed no correlation between presence or absence of a full thickness cuff tear and shoulder function The results of this study indicate that rotator cuff integrity is not a predictor of shoulder function at 12 months following proximal humeral fracture, as measured by outcome scores. This suggests that there is therefore no clinical indication for routine imaging of the rotator cuff in patients for whom conservative management is the preferred treatment option.
