Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data. In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.Aims
Methods
Surgical site infection (SSI) is a common complication of surgery
with an incidence of about 1% in the United Kingdom. Sutures can
lead to the development of a SSI, as micro-organisms can colonize
the suture as it is implanted. Triclosan-coated sutures, being antimicrobical,
were developed to reduce the rate of SSI. Our aim was to assess
whether triclosan-coated sutures cause a reduction in SSIs following
arthroplasty of the hip and knee. This two-arm, parallel, double-blinded study involved 2546 patients
undergoing elective total hip (THA) and total knee arthroplasty
(TKA) at three hospitals. A total of 1323 were quasi-randomized
to a standard suture group, and 1223 being quasi-randomized to the
triclosan-coated suture group. The primary endpoint was the rate
of SSI at 30 days postoperatively.Aims
Patients and Methods
This study aimed to compare the change in health-related quality
of life of patients receiving a traditional cemented monoblock Thompson
hemiarthroplasty compared with a modern cemented modular polished-taper
stemmed hemiarthroplasty for displaced intracapsular hip fractures. This was a pragmatic, multicentre, multisurgeon, two-arm, parallel
group, randomized standard-of-care controlled trial. It was embedded
within the WHiTE Comprehensive Cohort Study. The sample size was
964 patients. The setting was five National Health Service Trauma
Hospitals in England. A total of 964 patients over 60 years of age who
required hemiarthroplasty of the hip between February 2015 and March
2016 were included. A standardized measure of health outcome, the
EuroQol (EQ-5D-5L) questionnaire, was carried out on admission and
at four months following the operation.Aims
Patients and Methods
Objectives. This study reports on a secondary exploratory analysis of the early clinical outcomes of a randomised clinical trial comparing robotic arm-assisted unicompartmental knee arthroplasty (UKA) for medial compartment osteoarthritis of the knee with manual UKA performed using traditional surgical jigs. This follows reporting of the primary outcomes of implant accuracy and gait analysis that showed significant advantages in the robotic arm-assisted group. Methods. A total of 139 patients were recruited from a single centre. Patients were randomised to receive either a manual UKA implanted with the aid of traditional surgical jigs, or a UKA implanted with the aid of a tactile guided robotic arm-assisted system. Outcome measures included the American Knee Society Score (AKSS), Oxford Knee Score (OKS), Forgotten Joint Score, Hospital Anxiety Depression Scale, University of California at Los Angeles (UCLA) activity scale, Short Form-12, Pain Catastrophising Scale, somatic disease (Primary Care Evaluation of Mental Disorders Score), Pain visual analogue scale, analgesic use, patient satisfaction, complications relating to surgery, 90-day pain diaries and the requirement for revision surgery. Results. From the first post-operative day through to week 8 post-operatively, the median pain scores for the robotic arm-assisted group were 55.4% lower than those observed in the manual surgery group (p = 0.040). At three months post-operatively, the robotic arm-assisted group had better AKSS (robotic median 164, interquartile range (IQR) 131 to 178, manual median 143, IQR 132 to 166), although no difference was noted with the OKS. At one year post-operatively, the observed differences with the AKSS had narrowed from a median of 21 points to a median of seven points (p = 0.106) (robotic median 171, IQR 153 to 179; manual median 164, IQR 144 to 182). No difference was observed with the OKS, and almost half of each group reached the ceiling limit of the score (OKS > 43). A greater proportion of patients receiving robotic arm-assisted surgery improved their UCLA activity score. Binary logistic regression modelling for dichotomised outcome scores predicted the key factors associated with achieving excellent outcome on the AKSS: a pre-operative activity level > 5 on the UCLA activity score and use of robotic-arm surgery. For the same regression modelling, factors associated with a poor outcome were manual surgery and pre-operative depression. Conclusion. Robotic arm-assisted surgery results in improved early pain scores and early function scores in some patient-reported outcomes measures, but no difference was observed at one year post-operatively. Although improved results favoured the robotic arm-assisted group in active patients (i.e. UCLA ⩾ 5), these do not withstand adjustment for multiple comparisons. Cite this article: M. J. G. Blyth, I. Anthony, P. Rowe, M. S. Banger, A. MacLean, B. Jones. Robotic arm-assisted versus conventional unicompartmental knee arthroplasty: Exploratory secondary analysis of a
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
Objectives. The objective of this study was to assess all evidence comparing the Thompson monoblock hemiarthroplasty with modular unipolar implants for patients requiring hemiarthroplasty of the hip with respect to mortality and complications. Methods. A literature search was performed to identify all relevant literature. The population consisted of patients undergoing hemiarthroplasty of the hip for fracture. The intervention was hemiarthroplasty of the hip with a comparison between Thompson and modular unipolar prostheses. Pubmed, Embase, CINAHL, Web of Science, PROSPERO and the Cochrane Central Register of Controlled Trials. The study designs included were
The aim of this study was to compare the effectiveness of a femoral
nerve block and a periarticular infiltration in the management of
early post-operative pain after total knee arthroplasty (TKA). A pragmatic, single centre, two arm parallel group, patient blinded,
randomised controlled trial was undertaken. All patients due for
TKA were eligible. Exclusion criteria included contraindications
to the medications involved in the study and patients with a neurological
abnormality of the lower limb. Patients received either a femoral
nerve block with 75 mg of 0.25% levobupivacaine hydrochloride around
the nerve, or periarticular infiltration with 150 mg of 0.25% levobupivacaine
hydrochloride, 10 mg morphine sulphate, 30 mg ketorolac trometamol
and 0.25 mg of adrenaline all diluted with 0.9% saline to make a
volume of 150 ml.Aims
Patients and Methods
Objectives. The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery. Methods. A total of 17 DBM products were used as search terms in two available databases: Embase and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses statement. All articles that reported the clinical use of a DBM-product in trauma and orthopaedic related surgery were included. Results. The literature search resulted in 823 manuscripts of which 64 manuscripts met the final inclusion criteria. The included manuscripts consisted of four
Objectives. As tumours of bone and soft tissue are rare, multicentre prospective collaboration is essential for meaningful research and evidence-based advances in patient care. The aim of this study was to identify barriers and facilitators encountered in large-scale collaborative research by orthopaedic oncological surgeons involved or interested in prospective multicentre collaboration. Methods. All surgeons who were involved, or had expressed an interest, in the ongoing Prophylactic Antibiotic Regimens in Tumour Surgery (PARITY) trial were invited to participate in a focus group to discuss their experiences with collaborative research in this area. The discussion was digitally recorded, transcribed and anonymised. The transcript was analysed qualitatively, using an analytic approach which aims to organise the data in the language of the participants with little theoretical interpretation. Results. The 13 surgeons who participated in the discussion represented orthopaedic oncology practices from seven countries (Argentina, Brazil, Italy, Spain, Denmark, United States and Canada). Four categories and associated themes emerged from the discussion: the need for collaboration in the field of orthopaedic oncology due to the rarity of the tumours and the need for high level evidence to guide treatment; motivational factors for participating in collaborative research including establishing proof of principle, learning opportunity, answering a relevant research question and being part of a collaborative research community; barriers to participation including funding, personal barriers, institutional barriers, trial barriers, and administrative barriers and facilitators for participation including institutional facilitators, leadership, authorship, trial set-up, and the support of centralised study coordination. Conclusions. Orthopaedic surgeons involved in an ongoing international
Objectives. The Sliding Hip Screw (SHS) is commonly used to treat trochanteric hip fractures. Fixation failure is a devastating complication requiring complex revision surgery. One mode of fixation failure is lag screw cut-out which is greatest in unstable fracture patterns and when the tip-apex distance of the lag screw is > 25 mm. The X-Bolt Dynamic Hip Plating System (X-Bolt Orthopaedics, Dublin, Ireland) is a new device which aims to reduce this risk of cut-out. However, some surgeons have reported difficulty minimising the tip-apex distance with subsequent concerns that this may lead to an increased risk of cut-out. Patients and Methods. We measured the tip-apex distance from the intra-operative radiographs of 93 unstable trochanteric hip fractures enrolled in a
In this cross sectional study, the impact and the efficacy of a surveillance programme for sarcomas of the extremities was analysed. All patients who had treatment with curative intent for a high-grade sarcoma and were diagnosed before 2014 were included and followed for a minimum of two years.Objectives
Methods
Bisphosphonates are widely used as first-line treatment for primary and secondary prevention of fragility fractures. Whilst they have proved effective in this role, there is growing concern over their long-term use, with much evidence linking bisphosphonate-related suppression of bone remodelling to an increased risk of atypical subtrochanteric fractures of the femur (AFFs). The objective of this article is to review this evidence, while presenting the current available strategies for the management of AFFs. We present an evaluation of current literature relating to the pathogenesis and treatment of AFFs in the context of bisphosphonate use.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
A trial-based comparison of the use of resources, costs and quality
of life outcomes of arthroscopic and open surgical management for
rotator cuff tears in the United Kingdom NHS was performed using
data from the United Kingdom Rotator Cuff Study (UKUFF) randomised
controlled trial. Using data from 273 patients, healthcare-related use of resources,
costs and quality-adjusted life years (QALYs) were estimated at
12 months and 24 months after surgery on an intention-to-treat basis
with adjustment for covariates. Uncertainty about the incremental
cost-effectiveness ratio for arthroscopic Aims
Patients and Methods
Although vertebroplasty is very effective for relieving acute pain from an osteoporotic vertebral compression fracture, not all patients who undergo vertebroplasty receive the same degree of benefit from the procedure. In order to identify the ideal candidate for vertebroplasty, pre-operative prognostic demographic or clinico-radiological factors need to be identified. The objective of this study was to identify the pre-operative prognostic factors related to the effect of vertebroplasty on acute pain control using a cohort of surgically and non-surgically managed patients. Patients with single-level acute osteoporotic vertebral compression fracture at thoracolumbar junction (T10 to L2) were followed. If the patients were not satisfied with acute pain reduction after a three-week conservative treatment, vertebroplasty was recommended. Pain assessment was carried out at the time of diagnosis, as well as three, four, six, and 12 weeks after the diagnosis. The effect of vertebroplasty, compared with conservative treatment, on back pain (visual analogue score, VAS) was analysed with the use of analysis-of-covariance models that adjusted for pre-operative VAS scores.Objectives
Patients and Methods
Objectives. 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
