Aims. A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. Methods. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention
The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years.Aims
Methods
Venous thromboembolism (VTE) is a potential complication of foot and ankle surgery. There is a lack of agreement on contributing risk factors and chemical prophylaxis requirements. The primary outcome of this study was to analyze the 90-day incidence of symptomatic VTE and VTE-related mortality in patients undergoing foot and ankle surgery and Achilles tendon (TA) rupture. Secondary aims were to assess the variation in the provision of chemical prophylaxis and risk factors for VTE. This was a multicentre, prospective national collaborative audit with data collection over nine months for all patients undergoing foot and ankle surgery in an operating theatre or TA rupture treatment, within participating UK hospitals. The association between VTE and thromboprophylaxis was assessed with a univariable logistic regression model. A multivariable logistic regression model was used to identify key predictors for the risk of VTE.Aims
Methods
The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures. Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics.Aims
Methods
To compare the cost-utility of removable brace compared with cast in the management of adult patients with ankle fracture. A within-trial economic evaluation conducted from the UK NHS and personnel social services (PSS) perspective. Health resources and quality-of-life data were collected as part of the Ankle Injury Rehabilitation (AIR) multicentre, randomized controlled trial over a 12-month period using trial case report forms and patient-completed questionnaires. Cost-utility analysis was estimated in terms of the incremental cost per quality adjusted life year (QALY) gained. Estimate uncertainty was explored by bootstrapping, visualized on the incremental cost-effectiveness ratio plane. Net monetary benefit and probability of cost-effectiveness were evaluated at a range of willingness-to-pay thresholds and visualized graphically.Aims
Methods
Surgical reconstruction of deformed Charcot feet carries a high risk of nonunion, metalwork failure, and deformity recurrence. The primary aim of this study was to identify the factors contributing to these complications following hindfoot Charcot reconstructions. We retrospectively analyzed patients who underwent hindfoot Charcot reconstruction with an intramedullary nail between January 2007 and December 2019 in our unit. Patient demographic details, comorbidities, weightbearing status, and postoperative complications were noted. Metalwork breakage, nonunion, deformity recurrence, concurrent midfoot reconstruction, and the measurements related to intramedullary nail were also recorded.Aims
Methods
A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.Aims
Methods
Platelet rich plasma has been advocated for the treatment of plantar fasciitis but there are few good quality clinical trials to support its use. We report a pilot double blind randomised controlled trial of platelet rich plasma versus normal saline. Methods. Patients with more than 6 months of MRI proven plantar fasciitis who had failed conservative management were invited to participate in this study. Patients were block randomised to either platelet rich plasma injection (intervention) or equivalent volume of normal saline (control). The techniques used for the injection and rehabilitation were standardised for both groups. The patient and independent assessor were blinded. Visual analogue scale for pain (VAS) and painDETECT were recorded pre-op and at 6 months. Results. Twenty-eight patients (19 females, mean age 50 years) were recruited, with 14 randomised to each
To assess the characteristic clinical features, management, and outcome of patients who present to orthopaedic surgeons with functional dystonia affecting the foot and ankle. We carried out a retrospective search of our records from 2000 to 2019 of patients seen in our adult tertiary referral foot and ankle unit with a diagnosis of functional dystonia.Aims
Methods
Background:. Previous attempts at small incision hallux valgus surgery have compromised the principles of bunion correction in order to minimise the incision. The Minimally Invasive Chevron/Akin (MICA) is a technique that enables an open modified Chevron/Akin to be done through a 3 mm incision, facilitated by a 2 mm Shannon burr. Methodology:. This is a consecutive case series performed between 2009 and 2012. This includes the learning curve for minimally invasive surgery. All cases were performed by a single surgeon at two different sites, one centre where minimally invasive surgery is available and the other where it is not. The standard procedure in both centres is a modified Chevron osteotomy. Regardless of whether the osteotomy was performed open or minimally invasive two-screw fixation was performed. Retrospective analysis includes the IMA, HVA, M1 length, forefoot width and forefoot: hindfoot ratio. Clinical outcomes include the MOXFQ, AOFAS, and assessment of complications. Results:. There were 70 cases in each
Background. The Weil osteotomy is successful in the management of metatarsalgia and toe deformity. The aim is to achieve controlled shortening whilst avoiding plantarflexion. Recognised complications of the Weil osteotomy include a ‘floating toe’ in up to 20% or more of cases. Aim. Can modification of the Weil osteotomy avoid the metatarsal head plantarflexion and subsequent dorsal subluxation of the interosseous muscle that is implicated in the development of a ‘floating toe’. Methodology. The 2nd, 3rd and 4th rays were dissected out en bloc with all tendons attached from 6 pairs of fresh frozen cadavers. The ray was fixed to a board and the tendons physiologically balanced via low-friction pulleys and light weights. This model is highly sensitive to alterations in moment
Introduction:. Symptomatic treatment of ankle osteoarthritis (OA) with corticosteroid injections is well established. Hyaluronic acid is also reported as an effective symptomatic treatment for ankle OA but these two treatments have not been compared directly. Methods:. A prospective randomised controlled trial in patients with symptomatic ankle osteoarthritis. Twenty patients per group were required based on a significance level of 0.05, and a drop out rate of 5%. Patients were blindly allocated to the treatment or control group. Injections were carried out by the clinician in the outpatient department. Treatment group received Ostenil 20 mg and control group received Depomedrone 40 mg (both as single injections). The treatment
This project highlights the red flags in postoperative rehabilitation of total ankle replacement (TAR) patients managed with two different postoperative rehab regimes. 20 TAR patients were recruited for a pilot RCT between 2008 and 2011; they were randomized to 2 groups (immobilisation in a below knee plaster cast for 6 weeks vs. early mobilisation following TAR); all patients underwent a graded outpatient Physiotherapy program until 12 weeks postoperatively. Assessments included questionnaires, complications, American Orthopaedic Foot and Ankle Score (AOFAS) done preoperatively, 3 and 6 months after surgery. Results. 20 TARs for OA (13) and PTOA (7) took part in the trial. There were 10 patients in each
The aim was to compare long-term patient-reported outcome measures (PROMs) after operative and nonoperative treatment of acute Achilles tendon rupture in the context of a randomized controlled trial. PROMs including the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS), EuroQol five-dimension (EQ-5D), satisfaction, net promoter score and data regarding re-rupture, and venous thromboembolic rates were collected for patients randomized to receive either operative or nonoperative treatment for acute Achilles tendon rupture in a previous study. Of the 80 patients originally randomized, 64 (33 treated surgically, 31 nonoperatively) patients were followed up at a mean of 15.7 years (13.4 to 17.7).Aims
Methods
The anatomy of the mortise of the Lisfranc joint between the medial and lateral cuneiforms was studied in detail, with particular reference to features which may predispose to injury. In 33 consecutive patients with Lisfranc injuries we measured, from conventional radiographs, the medial depth of the mortise (A), the lateral depth (B) and the length of the second metatarsal (C). MRI was used to confirm the diagnosis. We calculated the mean depth of the mortise (A+B)/2, and the variables of the lever
We hypothesized that there is no difference in the clinical and radiological outcomes using local bone graft We prospectively studied 28 calcaneal malunion patients (the study group) who were managed by subtalar distraction arthrodesis using local calcaneal bone graft. The study group included 16 male and 12 female patients. The median age was 37.5 years (interquartile range (IQR) 29 to 43). The outcome of the study group was compared with a control group of ten patients previously managed by subtalar distraction arthrodesis using iliac bone graft. The control group included six male and four female patients. The median age was 41.5 years (IQR 36 to 44).Aims
Patients and Methods
This study reports the outcomes of a technique of soft-tissue coverage and Chopart amputation for severe crush injuries of the forefoot. Between January 2012 to December 2016, 12 patients (nine male; three female, mean age 38.58 years; 26 to 55) with severe foot crush injury underwent treatment in our institute. All patients were followed-up for at least one year. Their medical records, imaging, visual analogue scale score, walking ability, complications, and functional outcomes one year postoperatively based on the American Orthopedic Foot and Ankle Society (AOFAS) and 36-Item Short-Form Health Survey (SF-36) scores were reviewed.Aims
Patients and Methods
The purpose of this study was to compare symptomatic treatment
of a fracture of the base of the fifth metatarsal with immobilisation
in a cast. Our null hypothesis was that immobilisation gave better patient
reported outcome measures (PROMs). The alternative hypothesis was
that symptomatic treatment was not inferior. A total of 60 patients were randomised to receive four weeks
of treatment, 36 in a double elasticated bandage (symptomatic treatment
group) and 24 in a below-knee walking cast (immobilisation group).
The primary outcome measure used was the validated Visual Analogue
Scale Foot and Ankle (VAS-FA) Score. Data were analysed by a clinician,
blinded to the form of treatment, at presentation and at four weeks,
three months and six months after injury. Loss to follow-up was
43% at six months. Multiple imputations missing data analysis was performed.Aims
Patients and Methods
Few reports compare the contribution of the talonavicular articulation
to overall range of movement in the sagittal plane after total ankle
arthroplasty (TAA) and tibiotalar arthrodesis. The purpose of this
study was to assess changes in ROM and functional outcomes following
tibiotalar arthrodesis and TAA. Patients who underwent isolated tibiotalar arthrodesis or TAA
with greater than two-year follow-up were enrolled in the study.
Overall arc of movement and talonavicular movement in the sagittal
plane were assessed with weight-bearing lateral maximum dorsiflexion
and plantarflexion radiographs. All patients completed Short Form-12
version 2.0 questionnaires, visual analogue scale for pain (VAS)
scores, and the Foot and Ankle Ability Measure (FAAM).Aims
Patients and Methods
The foot and ankle outcome score (FAOS) has been
evaluated for many conditions of the foot and ankle. We evaluated
its construct validity in 136 patients with osteoarthritis of the
ankle, its content validity in 37 patients and its responsiveness
in 39. Data were collected prospectively from the registry of patients
at our institution. All FAOS subscales were rated relevant by patients. The Pain,
Activities of Daily Living, and Quality of Life subscales showed
good correlation with the Physical Component score of the Short-Form-12v2.
All subscales except Symptoms were responsive to change after surgery. We concluded that the FAOS is a weak instrument for evaluating
osteoarthritis of the ankle. However, some of the FAOS subscales
have relative strengths that allow for its limited use while we
continue to seek other satisfactory outcome instruments. Cite this article: