Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive.Aims
Methods
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
To achieve expert clinical consensus in the delivery of hydrodilatation for the treatment of primary frozen shoulder to inform clinical practice and the design of an intervention for evaluation. We conducted a two-stage, electronic questionnaire-based, modified Delphi survey of shoulder experts in the UK NHS. Round one required positive, negative, or neutral ratings about hydrodilatation. In round two, each participant was reminded of their round one responses and the modal (or ‘group’) response from all participants. This allowed participants to modify their responses in round two. We proposed respectively mandating or encouraging elements of hydrodilatation with 100% and 90% positive consensus, and respectively disallowing or discouraging with 90% and 80% negative consensus. Other elements would be optional.Aims
Methods
This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI. MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder.Aims
Methods
A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care. A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods.Aims
Methods
Few studies have compared aspirin with DOACs (direct oral anticoagulants = direct thrombin inhibitors and factor Xa inhibitors) for venous thromboembolism (VTE) prophylaxis following total hip and knee replacement (THR and TKR). We assessed the efficacy and safety of aspirin compared with DOACs for VTE prophylaxis following THR and TKR using the world's largest joint replacement registry. We studied the National Joint Registry linked to English hospital inpatient episodes for 218,650 THR and TKR patients. Patients receiving aspirin were matched separately to (1) direct thrombin inhibitors, and (2) factor Xa inhibitors using propensity scores. Outcomes assessed at 90 days included VTE, length of stay, and adverse events.Background
Methods
To explore whether orthopaedic surgeons have adopted the Proximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial results routinely into clinical practice. A questionnaire was piloted with six orthopaedic surgeons using a ‘think aloud’ process. The final questionnaire contained 29 items and was distributed online to surgeon members of the British Orthopaedic Association and British Elbow and Shoulder Society. Descriptive statistics summarised the sample characteristics and fracture treatment of respondents overall, and grouped them by whether they changed practice based on PROFHER trial findings. Free-text responses were analysed qualitatively for emerging themes using Framework Analysis principles.Objectives
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
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
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 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:
The peer review process for the evaluation of
manuscripts for publication needs to be better understood by the
orthopaedic community. Improving the degree of transparency surrounding
the review process and educating orthopaedic surgeons on how to
improve their manuscripts for submission will help improve both
the review procedure and resultant feedback, with an increase in
the quality of the subsequent publications. This article seeks to clarify
the peer review process and suggest simple ways in which the quality
of submissions can be improved to maximise publication success. 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
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
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
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.
Large and massive rotator cuff tears can cause persistent pain and significant disability. These tears are often chronic with substantial degeneration of the involved tendons. Surgical treatment is challenging and the functional outcome after repair less predictable then for smaller tears. The aim of this study was to determine the functional outcome and rate of re-rupture after mini-open repair of symptomatic large and massive rotator cuff tears using a modified two-row technique. Twenty-four patients, who were operated on under the care of a single surgeon between 2003 and 2006, were included in this study. Patients were assessed prospectively before and at a mean of 27 months after surgery using Constant Score and Oxford Shoulder Score. This assessment was carried out by an independent physiotherapist specialising in shoulder rehabilitation. At follow-up an ultrasound was carried out by a musculoskeletal radiographer to determine the integrity of the rotator cuff repair. Patient satisfaction was assessed using a simple questionnaire. The mean Constant Score improved significantly from 36 preoperatively to 68 postoperatively (p<
0.0001), the mean Oxford Shoulder Score from 39 to 20 (p<
0.0001). Four patients (16.7%) had a re-rupture diagnosed by ultrasound. 87.5% of patients were satisfied with the outcome of their surgery. Tear size and repair integrity did not significantly influence functional outcome. 87.5% of patients were satisfied or very satisfied with the outcome of their surgery. This study shows that the two-row repair of large and massive rotator cuff tears using a mini-open approach is an effective method of repair with a comparatively low re-rupture rate. It significantly improves the functional outcome and leads to a very high patient satisfaction. We conclude that these results justify repair of large to massive rotator cuff tears when possible, irrespective of chronicity of symptoms.
The PHILOS plate attempts to improve on previously designed implants by preserving the biological integrity of the humeral head articular fragment. The minimally invasive technique minimises soft tissue damage whilst at the same time securing the reduction using multiple locking screws with angular stability, thus allowing early mobilisation.
We also present a cost analysis relating to the use of the PHILOS plate in practice.
Mean OSS and DASH at follow up were 24.8 (S.D 11.6) and 28.0 (S.D 26.9) respectively. Worse scores were seen in those patients who had complications (OSS 39.4 Vs 22.6, DASH 58.2 Vs 23.4) although this difference was not statistically significant. There was also a trend for poorer scores with increasing fracture complexity and better scores in those patients operated upon by surgeons with a specific interest in the upper limb and in patients whose surgeon had performed more than 5 fixations.
Upper gastrointestinal (GI) bleeding in patients who undergo hip and knee arthroplasty tends to be associated with NSAID use, steroid intake, pre-existing peptic ulcers and smoking. The use of Aspirin for thromboprophylaxis is an added risk for the occurrence of GI Bleed. The aim of this study was to determine if the use of peri-operative oral Ranitidine reduces the incidence of GI bleeding when Aspirin thromboprophylaxis is used for hip and knee arthroplasty. Data from 1491 consecutive patients who underwent Hip and knee replacements at the James cook university hospital (Group 1) and 886 patients who underwent Hip and Knee replacements at the Friarage hospital, Northallerton (Group 2) was analysed to determine the incidence of Gastro intestinal Bleeding. All patients received 150 mg of Aspirin per day for a period of six weeks from the day of surgery. Additionally patients operated at the Friarage Hospital received 300 mg of oral Ranitidine per day, for three postoperative days. Patients with clinically symptomatic GI bleeding were evaluated by the Upper GI team. We observed that patients in Group 1 had a higher incidence of overt upper GI haemorrhage (n=14), which was statistically significant (p <
0.014) compared with patients in group 2(n=1). From the pooled data of both groups, there were 18 reported patients with symptomatic pulmonary embolism (0.75%) 3 of which were fatal (0.12%), phlebitis of deep leg veins in 31 patients (1.3%), deep vein thrombosis in 34 patients (1.43%), 5 of whom had embolic episodes, post operative infection in 22 patients (1.13%), and postoperative haemorrhage in 5 patients (0.2%). Thromboembolic phenomenon and pulmonary embolism was confirmed by autopsy in the three cases. Based on this experience, we recommend the use of peri-operative gastric protection when aspirin is used for thromboprophylaxis in hip and knee arthroplasty.
