Aims. To describe outcome reporting variation and trends in non-pharmacological randomized
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. 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.Aims
Methods
Aims. The optimal management of posterior malleolar ankle fractures, a prevalent type of ankle trauma, is essential for improved prognosis. However, there remains a debate over the most effective surgical approach, particularly between screw and plate fixation methods. This study aims to investigate the differences in outcomes associated with these fixation techniques. Methods. We conducted a comprehensive review of
Although absorbable sutures for the repair of acute Achilles tendon rupture (ATR) have been attracting attention, the rationale for their use remains insufficient. This study prospectively compared the outcomes of absorbable and nonabsorbable sutures for the repair of acute ATR. A total of 40 patients were randomly assigned to either braided absorbable polyglactin suture or braided nonabsorbable polyethylene terephthalate suture groups. ATR was then repaired using the Krackow suture method. At three and six months after surgery, the isokinetic muscle strength of ankle plantar flexion was measured using a computer-based Cybex dynamometer. At six and 12 months after surgery, patient-reported outcomes were measured using the Achilles tendon Total Rupture Score (ATRS), visual analogue scale for pain (VAS pain), and EuroQoL five-dimension health questionnaire (EQ-5D).Aims
Methods
The rationale for exacting restoration of skeletal anatomy after unstable ankle fracture is to improve outcomes by reducing complications from malunion; however, current definitions of malunion lack confirmatory clinical evidence. Radiological (absolute radiological measurements aided by computer software) and clinical (clinical interpretation of radiographs) definitions of malunion were compared within the Ankle Injury Management (AIM) trial cohort, including people aged ≥ 60 years with an unstable ankle fracture. Linear regressions were used to explore the relationship between radiological malunion (RM) at six months and changes in function at three years. Function was assessed with the Olerud-Molander Ankle Score (OMAS), with a minimal clinically important difference set as six points, as per the AIM trial. Piecewise linear models were used to investigate new radiological thresholds which better explain symptom impact on ankle function.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 identify a core outcome set of postoperative radiographic measurements to assess technical skill in ankle fracture open reduction internal fixation (ORIF), and to validate these against Van der Vleuten’s criteria for effective assessment. An e-Delphi exercise was undertaken at a major trauma centre (n = 39) to identify relevant parameters. Feasibility was tested by two authors. Reliability and validity was tested using postoperative radiographs of ankle fracture operations performed by trainees enrolled in an educational trial (IRCTN 20431944). To determine construct validity, trainees were divided into novice (performed < ten cases at baseline) and intermediate groups (performed ≥ ten cases at baseline). To assess concurrent validity, the procedure-based assessment (PBA) was considered the gold standard. The inter-rater and intrarater reliability was tested using a randomly selected subset of 25 cases.Aims
Methods
Treatment for delayed wound healing resulting from peripheral vascular diseases and diabetic foot ulcers remains a challenge. A novel surgical technique named ‘tibial cortex transverse transport’ (TTT) has been developed for treating peripheral ischaemia, with encouraging clinical effects. However, its underlying mechanisms remain unclear. In the present study, we explored the potential biological mechanisms of TTT surgery using various techniques in a rat TTT animal model. A novel rat model of TTT was established with a designed external fixator, and effects on wound healing were investigated. Laser speckle perfusion imaging, vessel perfusion, histology, and immunohistochemistry were used to evaluate the wound healing processes.Aims
Methods
In recent years, the plantaris tendon has been
implicated in the development of chronic painful mid-portion Achilles tendinopathy.
In some cases, a thickened plantaris tendon is closely associated
with the Achilles tendon, and surgical excision of the plantaris
tendon has been reported to be curative in patients who have not
derived benefit following conservative treatment and surgical interventions. The aim of this review is to outline the basic aspects of, and
the recent research findings, related to the plantaris tendon, covering
anatomical and
The ideal management of acute syndesmotic injuries in elite athletes is controversial. Among several treatment methods used to stabilize the syndesmosis and facilitate healing of the ligaments, the use of suture tape (InternalBrace) has previously been described. The purpose of this study was to analyze the functional outcome, including American Orthopaedic Foot & Ankle Society (AOFAS) scores, knee-to-wall measurements, and the time to return to play in days, of unstable syndesmotic injuries treated with the use of the InternalBrace in elite athletes. Data on a consecutive group of elite athletes who underwent isolated reconstruction of the anterior inferior tibiofibular ligament using the InternalBrace were collected prospectively. Our patient group consisted of 19 elite male athletes with a mean age of 24.5 years (17 to 52). Isolated injuries were seen in 12 patients while associated injuries were found in seven patients (fibular fracture, medial malleolus fracture, anterior talofibular ligament rupture, and posterior malleolus fracture). All patients had a minimum follow-up period of 17 months (mean 27 months (17 to 35)).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
The hypothesis of this study was that bone peg fixation in the treatment of osteochondral lesions of the talus would show satisfactory clinical and radiological results, without complications. Between September 2014 and July 2017, 25 patients with symptomatic osteochondritis of the talus and an osteochondral fragment, who were treated using bone peg fixation, were analyzed retrospectively. All were available for complete follow-up at a mean 22 of months (12 to 35). There were 15 males and ten females with a mean age of 19.6 years (11 to 34). The clinical results were evaluated using a visual analogue scale (VAS) and the American Orthopaedic Foot and Ankle Society (AOFAS) score preoperatively and at the final follow-up. The radiological results were evaluated using classification described by Hepple et al based on the MRI findings, the location of the lesion, the size of the osteochondral fragment, and the postoperative healing of the lesion.Aims
Methods
Lengthening of the conjoined tendon of the gastrocnemius
aponeurosis and soleus fascia is frequently used in the treatment
of equinus deformities in children and adults. The Vulpius procedure
as described in most orthopaedic texts is a division of the conjoined
tendon in the shape of an inverted V. However, transverse division
was also described by Vulpius and Stoffel, and has been reported
in some
In the context of tendon degenerative disorders, the need for innovative conservative treatments that can improve the intrinsic healing potential of tendon tissue is progressively increasing. In this study, the role of pulsed electromagnetic fields (PEMFs) in improving the tendon healing process was evaluated in a rat model of collagenase-induced Achilles tendinopathy. A total of 68 Sprague Dawley rats received a single injection of type I collagenase in Achilles tendons to induce the tendinopathy and then were daily exposed to PEMFs (1.5 mT and 75 Hz) for up to 14 days - starting 1, 7, or 15 days after the injection - to identify the best treatment option with respect to the phase of the disease. Then, 7 and 14 days of PEMF exposure were compared to identify the most effective protocol.Aims
Methods
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
The aim of this study was to evaluate the functional outcome in patients undergoing implant removal (IR) after fracture fixation below the level of the knee. All adult patients (18 to 75 years) undergoing IR after fracture fixation below the level of the knee between November 2014 and September 2016 were included as part of the WIFI (Wound Infections Following Implant Removal Below the Knee) trial, performed in 17 teaching hospitals and two university hospitals in The Netherlands. In this multicentre prospective cohort, the primary outcome was the difference in functional status before and after IR, measured by the Lower Extremity Functional Scale (LEFS), with a minimal clinically important difference of nine points.Aims
Patients and Methods
Anatomical atlases document classical safe corridors for the
placement of transosseous fine wires through the calcaneum during
circular frame external fixation. During this process, the posterior
tibial neurovascular bundle (PTNVB) is placed at risk, though this
has not been previously quantified. We describe a cadaveric study
to investigate a safe technique for posterolateral to anteromedial
fine wire insertion through the body of the calcaneum. A total of 20 embalmed cadaveric lower limbs were divided into
two groups. Wires were inserted using two possible insertion points
and at varying angles. In Group A, wires were inserted one-third
along a line between the point of the heel and the tip of the lateral
malleolus while in Group B, wires were inserted halfway along this
line. Standard dissection techniques identified the structures at
risk and the distance of wires from neurovascular structures was measured.
The results from 19 limbs were subject to analysis.Aims
Materials and Methods
There has been an evolution recently in the management of unstable
fractures of the ankle with a trend towards direct fixation of a
posterior malleolar fragment. Within these fractures, Haraguchi
type 2 fractures extend medially and often cannot be fixed using
a standard posterolateral approach. Our aim was to describe the
posteromedial approach to address these fractures and to assess
its efficacy and safety. We performed a review of 15 patients with a Haraguchi type 2
posterior malleolar fracture which was fixed using a posteromedial
approach. Five patients underwent initial temporary spanning external
fixation. The outcome was assessed at a median follow-up of 29 months (interquartile
range (IQR) 17 to 36) using the Olerud and Molander score and radiographs were
assessed for the quality of the reduction.Aims
Patients and Methods
To determine whether the findings from a landmark Canadian trial
assessing the optimal management of acute rupture of the Achilles
tendon influenced the practice patterns of orthopaedic surgeons
in Ontario, Canada. Health administrative databases were used to identify Ontario
residents ≥ 18 years of age with an Achilles tendon rupture from
April 2002 to March 2014. The rate of surgical repair (per 100 cases)
was calculated for each calendar quarter. A time-series analysis
was used to determine whether changes in the rate were chronologically
related to the dissemination of results from a landmark trial published
in February 2009. Non-linear spline regression was then used independently
to identify critical time-points of change in the surgical repair
rate to confirm the findings.Aims
Materials and Methods
Inflammation of the retrocalcaneal bursa (RB) is a common clinical problem, particularly in professional athletes. RB inflammation is often treated with corticosteroid injections however a number of reports suggest an increased risk of Achilles tendon (AT) rupture. The aim of this cadaveric study was to describe the anatomical connections of the RB and to investigate whether it is possible for fluid to move from the RB into AT tissue. A total of 20 fresh-frozen AT specimens were used. In ten specimens, ink was injected into the RB. The remaining ten specimens were split into two groups to be injected with radiological contrast medium into the RB either with or without ultrasonography guidance (USG).Objectives
Methods
Involvement of the posterior malleolus in fractures of the ankle
probably adversely affects the functional outcome and may be associated
with the development of post-traumatic osteoarthritis. Anatomical
reduction is a predictor of a successful outcome. The purpose of this study was to describe the technique and short-term
outcome of patients with trimalleolar fractures, who were treated
surgically using a posterolateral approach in our hospital between
2010 and 2014. The study involved 52 patients. Their mean age was 49 years (22
to 79). There were 41 (79%) AO 44B-type and 11 (21%) 44C-type fractures.
The mean size of the posterior fragment was 27% (10% to 52%) of
the tibiotalar joint surface.Aims
Patients and Methods
Patients with an acute Achilles tendon rupture (ATR) take a long
time to heal, have a high incidence of deep vein thrombosis (DVT)
and widely variable functional outcomes. This variation in outcome
may be explained by a lack of knowledge of adverse factors, and
a subsequent shortage of appropriate interventions. A total of 111 patients (95 men, 16 women; mean age 40.3, standard
deviation 8.4) with an acute total ATR were prospectively assessed.
At one year post-operatively a uniform outcome score, Achilles Combined
Outcome Score (ACOS), was obtained by combining three validated,
independent, outcome measures: Achilles tendon Total Rupture Score,
heel-rise height test, and limb symmetry heel-rise height. Predictors
of ACOS included treatment; gender; age; smoking; body mass index;
time to surgery; physical activity level pre- and post-injury; symptoms; quality
of life and incidence of DVT. Aims
Patients and Methods
Sporting injuries around the ankle vary from
simple sprains that will resolve spontaneously within a few days
to severe injuries which may never fully recover and may threaten
the career of a professional athlete. Some of these injuries can
be easily overlooked altogether or misdiagnosed with potentially
devastating effects on future performance. In this review article,
we cover some of the common and important sporting injuries involving
the ankle including updates on their management and outcomes. Cite this article:
Osteochondral lesions (OCLs) occur in up to 70%
of sprains and fractures involving the ankle. Atraumatic aetiologies have
also been described. Techniques such as microfracture, and replacement
strategies such as autologous osteochondral transplantation, or
autologous chondrocyte implantation are the major forms of surgical
treatment. Current literature suggests that microfracture is indicated
for lesions up to 15 mm in diameter, with replacement strategies
indicated for larger or cystic lesions. Short- and medium-term results
have been reported, where concerns over potential deterioration
of fibrocartilage leads to a need for long-term evaluation. Biological augmentation may also be used in the treatment of
OCLs, as they potentially enhance the biological environment for
a natural healing response. Further research is required to establish
the critical size of defect, beyond which replacement strategies
should be used, as well as the most appropriate use of biological augmentation.
This paper reviews the current evidence for surgical management
and use of biological adjuncts for treatment of osteochondral lesions
of the talus. Cite this article:
Clinicians are often asked by patients, “When
can I drive again?” after lower limb injury or surgery. This question
is difficult to answer in the absence of any guidelines. This review
aims to collate the currently available evidence and discuss the
factors that influence the decision to allow a patient to return
to driving. There is currently insufficient evidence for any authoritative
body to determine fitness to drive. The lack of guidance could result
in patients being withheld from driving for longer than is necessary,
or returning to driving while still unsafe. Cite this article:
The Manchester–Oxford Foot Questionnaire (MOXFQ) is a validated
16-item, patient-reported outcome measure for evaluating outcomes
of foot or ankle surgery. The original development of the instrument
identified three domains. This present study examined whether the
three domains could legitimately be summed to provide a single summary
index score. The MOXFQ and Short-Form (SF)-36 were administered to 671 patients
before surgery of the foot or ankle. Data from the three domains
of the MOXFQ (pain, walking/standing and social interaction) were
subjected to higher order factor analysis. Reliability and validity
of the summary index score was assessed.Objectives
Methods
It has been suggested that extracorporeal shockwave
therapy is a safe and effective treatment for pain relief from recalcitrant
plantar fasciopathy (PF). However, the changes in gait and associated
biomechanical parameters have not been well characterised. We recruited
12 female patients with recalcitrant PF who had a mean age of 59
years (50 to 70) and mean body mass index of 25 kg/m2 (22
to 30). The patients reported a mean duration of symptoms of 9.3
months (6 to 15). Shockwave therapy consisting of 1500 impulses
(energy flux density 0.26 mJ/mm2) was applied for three
sessions, each three weeks apart. A pain visual analogue scale (VAS)
rating, plantar pressure assessment and motion analysis were carried
out before and nine weeks after first shock wave therapy. It was demonstrated
that patients increased their walking velocity and cadence as well
indicating a decrease in pain after shockwave therapy. In the symptomatic
foot, the peak contact pressure over the forefoot increased and
the contact area over the digits decreased. The total foot impulse
also decreased as did stance duration. The duration the centre of
pressure remained in the hindfoot increased in the symptomatic foot
after shockwave therapy. The differences in centre of pressure trajectory
at baseline decreased at final follow-up. In conclusion, shockwave
therapy not only decreased the pain VAS rating but also improved
the gait parameters of the symptomatic foot in PF patients. Cite this article:
We conducted a randomised controlled trial to
determine whether active intense pulsed light (IPL) is an effective treatment
for patients with chronic mid-body Achilles tendinopathy. A total
of 47 patients were randomly assigned to three weekly therapeutic
or placebo IPL treatments. The primary outcome measure was the Victorian
Institute of Sport Assessment – Achilles (VISA-A) score. Secondary
outcomes were a visual analogue scale for pain (VAS) and the Lower
Extremity Functional Scale (LEFS). Outcomes were recorded at baseline,
six weeks and 12 weeks following treatment. Ultrasound assessment
of the thickness of the tendon and neovascularisation were also
recorded before and after treatment. There was no significant difference between the groups for any
of the outcome scores or ultrasound measurements by 12 weeks, showing
no measurable benefit from treatment with IPL in patients with Achilles tendinopathy. Cite this article:
The Bologna–Oxford (BOX) total ankle replacement
(TAR) was developed with the aim of achieving satisfactory pain-free
movement of the ankle. To date, only one single multicentre study
has reported its clinical results. The aim of this study was to
conduct an independent review of its mid-term results. We retrospectively reviewed a total of 60 prospectively followed
patients in whom 62 BOX TARs had been implanted between 2004 and
2008. We used the American Orthopedic Foot and Ankle Society (AOFAS)
score to assess the clinical results. Standardised radiographs taken
at the time of final follow-up were analysed by two observers. The
overall survival was 91.9% at a mean follow-up of 42.5 months (24
to 71). The mean AOFAS score had improved from 35.1 points (
The responsiveness of the Manchester–Oxford Foot
Questionnaire (MOXFQ) was compared with foot/ankle-specific and
generic outcome measures used to assess all surgery of the foot
and ankle. We recruited 671 consecutive adult patients awaiting
foot or ankle surgery, of whom 427 (63.6%) were female, with a mean
age of 52.8 years (18 to 89). They independently completed the MOXFQ,
Short-Form 36 (SF-36) and EuroQol (EQ-5D) questionnaires pre-operatively
and at a mean of nine months (3.8 to 14.4) post-operatively. Foot/ankle
surgeons assessed American Orthopaedic Foot and Ankle Society (AOFAS)
scores corresponding to four foot/ankle regions. A transition item measured
perceived changes in foot/ankle problems post-surgery. Of 628 eligible
patients proceeding to surgery, 491 (78%) completed questionnaires
and 262 (42%) received clinical assessments both pre- and post-operatively. The
regions receiving surgery were: multiple/whole foot in eight (1.3%),
ankle/hindfoot in 292 (46.5%), mid-foot in 21 (3.3%), hallux in
196 (31.2%), and lesser toes in 111 (17.7%). Foot/ankle-specific
MOXFQ, AOFAS and EQ-5D domains produced larger effect sizes (>
0.8)
than any SF-36 domains, suggesting superior responsiveness. In analyses
that anchored change in scores and effect sizes to patients’ responses
to a transition item about their foot/ankle problems, the MOXFQ
performed well. The SF-36 and EQ-5D performed poorly. Similar analyses,
conducted within foot-region based sub-groups of patients, found
that the responsiveness of the MOXFQ was good compared with the
AOFAS. This evidence supports the MOXFQ’s suitability for assessing
all foot and ankle surgery.
We studied a cohort of 26 diabetic patients with chronic ulceration under the first metatarsal head treated by a modified Jones extensor hallucis longus and a flexor hallucis longus transfer. If the first metatarsal was still plantar flexed following these two transfers, a peroneus longus to the peroneus brevis tendon transfer was also performed. Finally, if ankle dorsiflexion was <
5° with the knee extended, a Strayer-type gastrocnemius recession was performed. The mean duration of chronic ulceration despite a minimum of six months’ conservative care was 16.2 months (6 to 31). A total of 23 of the 26 patients were available for follow-up at a mean of 39.6 months (12 to 61) after surgery. All except one achieved complete ulcer healing at a mean of 4.4 weeks (2 to 8) after surgery, and there was no recurrence of ulceration under the first metatarsal. We believe that tendon balancing using modified Jones extensor hallucis longus and flexor hallucis longus transfers, associated in selected cases with a peroneus longus to brevis transfer and/or Strayer procedure, can promote rapid and sustained healing of chronic diabetic ulcers under the first metatarsal head.
We report an audit of 208 patients with a mean age of 39 years (16 to 65) attending the Orthopaedic Assessment Unit at the Wellington Hospital between January 2006 and December 2007 with an injury of the tendo Achillis requiring immobilisation in a cast. Information on assessment of venous thromboembolism (VTE) risk, prophylactic measures and VTE events for all patients was obtained from the medical records. A VTE risk factor was documented in the records of three (1%) patients. One of the 208 patients received aspirin prophylaxis; none received low molecular weight heparin. In all, 13 patients (6.3%, 95% confidence interval 3.4 to 10.5) developed symptomatic VTE during immobilisation in a cast, including six with a distal deep-vein thrombosis (DVT), four with a proximal DVT, and three with a confirmed pulmonary embolus. This incidence of symptomatic VTE is similar to that reported following elective hip replacement. We propose that consideration is given to VTE prophylaxis during prolonged immobilisation of the lower limbs in a cast, to ensure that the same level of protection is provided as for patients undergoing elective hip replacement.
Supination-external rotation (SER) fractures of the ankle may present with a medial ligamentous injury that is not apparent on the initial radiographs. A cadaver gravity-stress view has been described, but the manual-stress view is considered to be the examination of choice for the diagnosis of medial injuries. We prospectively compared the efficacy of these two examinations. We undertook both examinations in 29 patients with SER fractures. Of these, 16 (55%) were stress-positive, i.e. and had widening of the medial clear space of >
4 mm with a mean medial clear space of 6.09 mm (4.4 to 8.1) on gravity-stress and 5.81 mm (4.0 to 8.2) on manual-stress examination, and 13 patients (45%) were stress-negative with a mean medial clear space of 3.91 mm (3.3 to 5.1) and 3.61 mm (2.6 to 4.5) on examination of gravity- and manual-stress respectively. The mean absolute visual analgoue scale score for discomfort in the examination of gravity stress was 3.45 (1 to 6) and in the manual-stress procedure 6.14 (3 to 10). We have shown that examination of gravity-stress is as reliable and perceived as more comfortable than that of manual stress. We recommend using it as the initial diagnostic screening examination for the detection of occult medial ligamentous injuries in SER fractures of the ankle.