Aims. The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS). Methods. All patients included in the ‘ROutine vs on DEmand removal Of the syndesmotic screw’ (RODEO) trial received the Olerud-Molander Ankle Score (OMAS), American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Foot and Ankle Outcome Score (FAOS), and EuroQol five-dimension questionnaire (EQ-5D). Out of the 152 patients, 109 (71.7%) completed the mid-term follow-up questionnaire and were included in this study (53 treated with RR and 56 with ODR). Median follow-up was 50 months (interquartile range 43.0 to 56.0) since the initial surgical treatment of the acute syndesmotic injury. The primary outcome of this study consisted of the OMAS scores of the two groups. Results. The median OMAS score was 85.0 for patients treated with RR, and 90.0 for patients treated with ODR (p = 0.384), indicating no significant difference between ODR and RR. The secondary outcome measures included the AOFAS (88.0 in the RR group and 90.0 for ODR; p = 0.722), FAOS (87.5 in the RR group and 92.9 for ODR; p = 0.399), and
To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed.Aims
Methods
Aims. 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. Methods. 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). Results. Overall, 37 patients completed 12 months of follow-up. No difference was observed between the two groups in terms of isokinetic plantar flexion strength, ATRS, VAS pain, or
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
This is a multicentre, non-inventor, prospective observational study of 503 INFINITY fixed bearing total ankle arthroplasties (TAAs). We report our early experience, complications, and radiological and functional outcomes. Patients were recruited from 11 specialist centres between June 2016 and November 2019. Demographic, radiological, and functional outcome data (Ankle Osteoarthritis Scale, Manchester Oxford Questionnaire, and EuroQol five-dimension five-level score) were collected preoperatively, at six months, one year, and two years. The Canadian Orthopaedic Foot and Ankle Society (COFAS) grading system was used to stratify deformity. Early and late complications and reoperations were recorded as adverse events. Radiographs were assessed for lucencies, cysts, and/or subsidence.Aims
Methods
We report the medium-term outcomes of a consecutive series of 118 Zenith total ankle arthroplasties (TAAs) from a single, non-designer centre. Between December 2010 and May 2016, 118 consecutive Zenith prostheses were implanted in 114 patients. Demographic, clinical, and patient-reported outcome measures (PROMs) data were collected. The endpoint of the study was failure of the implant requiring revision of one or all of the components. Kaplan-Meier survival curves were generated with 95% confidence intervals (CIs) and the rate of failure calculated for each year.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
Aims. 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. Methods. 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). Results. There was no statistically significant difference between operatively and nonoperatively treated patients, in SMFA Dysfunction Index (median 1.56 (interquartile range (IQR) 0 to 5.51) vs 1.47 (IQR 0 to 5.15); p = 0.289), SMFA Bother Index (2.08 (IQR 0 to 12.50) vs 0.00 (IQR 0 to 6.25); p = 0.074), ATRS (94 (IQR 86 to 100) vs 95 (IQR 81 to 100); p = 0.313), EQ-5D-5L (1 (IQR 0.75 to 1) vs 1 (IQR 0.84 to 1); p = 0.137) or
In a randomized controlled trial with two-year follow-up, patients treated with suture button (SB) for acute syndesmotic injury had better outcomes than patients treated with syndesmotic screw (SS). The aim of this study was to compare clinical and radiological outcomes for these treatment groups after five years. A total of 97 patients with acute syndesmotic injury were randomized to SS or SB. The five-year follow-up rate was 81 patients (84%). The primary outcome was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Scale. Secondary outcome measures included Olerud-Molander Ankle (OMA) score, visual analogue scale (VAS), EuroQol five-dimension questionnaire (EQ-5D), range of movement, complications, reoperations, and radiological results. CT scans of both ankles were obtained after surgery, and after one, two, and five years.Aims
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
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
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
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
The outcome in 83 patients with congenital clubfoot was evaluated at a mean age of 64 years using three validated questionnaires assessing both quality of life (short-form (SF)-36 and EQ-5D) and foot and ankle function (American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire). In SF-36, male patients scored significantly better than male norms in seven of the eight domains, whereas female patients scored significantly worse than female norms in two of the eight. Male patients scored better than male norms in both the
