The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment.Aims
Methods
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
The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children’s Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children’s Elbows (SCIENCE) trial. Children aged seven to 15 years old inclusive, who have sustained a displaced fracture of the medial epicondyle, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score, pain measured using the Wong Baker FACES pain scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger patients (EQ-5D-Y) will be collected. Each patient will be randomly allocated (1:1, stratified using a minimization algorithm by centre and initial elbow dislocation status (i.e. dislocated or not-dislocated at presentation to the emergency department)) to either a regimen of the operative fixation or non-surgical treatment.Aims
Methods
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
The aim of this study was to identify variables associated with time to revision, demographic details associated with revision indication, and type of prosthesis employed, and to describe the survival of hinge knee arthroplasty (HKA) when used for first-time knee revision surgery and factors that were associated with re-revision. Patient demographic details, BMI, American Society of Anesthesiologists (ASA) grade, indication for revision, surgical approach, surgeon grade, implant type (fixed and rotating), time of revision from primary implantation, and re-revision if undertaken were obtained from the National Joint Registry data for England, Wales, Northern Ireland, and the Isle of Man over an 18-year period (2003 to 2021).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
Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization. FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately.Aims
Methods
Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures . Children aged four to 15-years-old inclusive who have sustained a torus/buckle fracture of the distal radius with/without an injury to the ulna are eligible to take part. Baseline pain as measured by the Wong Baker FACES pain scale, function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb, and quality of life (QoL) assessed with the EuroQol EQ-5D-Y will be collected. Each patient will be randomly allocated (1:1, stratified by centre and age group (four to seven years and ≥ eight years) to either a regimen of the offer of a soft bandage and immediate discharge or rigid immobilization and follow-up as per the protocol of the treating centre.Aims
Methods
Antibiotic-loaded bone cements (ALBCs) may offer early protection against the formation of bacterial biofilm after joint arthroplasty. Use in hip arthroplasty is widely accepted, but there is a lack of evidence in total knee arthroplasty (TKA). The objective of this study was to evaluate the use of ALBC in a large population of TKA patients. Data from the National Joint Registry (NJR) of England and Wales were obtained for all primary cemented TKAs between March 2003 and July 2016. Patient, implant, and surgical variables were analyzed. Cox proportional hazards models were used to assess the influence of ALBC on risk of revision. Body mass index (BMI) data were available in a subset of patients.Aims
Materials and Methods
The popularity of cementless total hip replacement
(THR) has surpassed cemented THR in England and Wales. This retrospective
cohort study records survival time to revision following primary
cementless THR with the most common combination (accounting for
almost a third of all cementless THRs), and explores risk factors independently
associated with failure, using data from the National Joint Registry
for England and Wales. Patients with osteoarthritis who had a DePuy
Corail/Pinnacle THR implanted between the establishment of the registry
in 2003 and 31 December 2010 were included within analyses. There
were 35 386 procedures. Cox proportional hazard models were used
to analyse the extent to which the risk of revision was related
to patient, surgeon and implant covariates. The overall rate of
revision at five years was 2.4% (99% confidence interval 2.02 to
2.79). In the final adjusted model, we found that the risk of revision
was significantly higher in patients receiving metal-on-metal (MoM:
hazard ratio (HR) 1.93, p <
0.001) and ceramic-on-ceramic bearings
(CoC: HR 1.55, p = 0.003) compared with the best performing bearing
(metal-on-polyethylene). The risk of revision was also greater for
smaller femoral stems (sizes 8 to 10: HR 1.82, p <
0.001) compared
with mid-range sizes. In a secondary analysis of only patients where body
mass index (BMI) data were available (n = 17 166), BMI ≥ 30 kg/m2 significantly
increased the risk of revision (HR 1.55, p = 0.002). The influence
of the bearing on the risk of revision remained significant (MoM:
HR 2.19, p <
0.001; CoC: HR 2.09,
p = 0.001). The risk of revision was independent of age, gender,
head size and offset, shell, liner and stem type, and surgeon characteristics. We found significant differences in failure between bearing surfaces
and femoral stem size after adjustment for a range of covariates
in a large cohort of single-brand cementless THRs. In this study
of procedures performed since 2003, hard bearings had significantly
higher rates of revision, but we found no evidence that head size
had an effect. Patient characteristics, such as BMI and American
Society of Anesthesiologists grade, also influence the survival
of cementless components. Cite this article:
Despite excellent results, the use of cemented
total hip replacement (THR) is declining. This retrospective cohort study
records survival time to revision following primary cemented THR
using the most common combination of components that accounted for
almost a quarter of all cemented THRs, exploring risk factors independently associated
with failure. All patients with osteoarthritis who had an Exeter
V40/Contemporary THR (Stryker) implanted before 31 December 2010
and recorded in the National Joint Registry for England and Wales
were included in the analysis. Cox’s proportional hazard models
were used to analyse the extent to which risk of revision was related
to patient, surgeon and implant covariates, with a significance
threshold of p <
0.01. A total of 34 721 THRs were included in
the study. The overall seven-year rate of revision for any reason
was 1.70% (99% confidence interval (CI) 1.28 to 2.12). In the final
adjusted model the risk of revision was significantly higher in
THRs with the Contemporary hooded component (hazard ratio (HR) 1.88,
p <
0.001) than with the flanged version, and in smaller head
sizes (<
28 mm) compared with 28 mm diameter heads (HR 1.50,
p = 0.005). The seven-year revision rate was 1.16% (99% CI 0.69
to 1.63) with a 28 mm diameter head and flanged component. The overall
risk of revision was independent of age, gender, American Society
of Anesthesiologists grade, body mass index, surgeon volume, surgical
approach, brand of cement/presence of antibiotic, femoral head material
(stainless steel/alumina) and stem taper size/offset. However, the
risk of revision for dislocation was significantly higher with a
‘plus’ offset head (HR 2.05, p = 0.003) and a hooded acetabular component
(HR 2.34, p <
0.001). In summary, we found that there were significant differences
in failure between different designs of acetabular component and
sizes of femoral head after adjustment for a range of covariates.
United Kingdom National Institute for Health
and Clinical Excellence guidelines recommend the use of total hip replacement
(THR) for displaced intracapsular fractures of the femoral neck
in cognitively intact patients, who were independently mobile prior
to the injury. This study aimed to analyse the risk factors associated
with revision of the implant and mortality following THR, and to
quantify risk. National Joint Registry data recording a THR performed
for acute fracture of the femoral neck between 2003 and 2010 were
analysed. Cox proportional hazards models were used to investigate
the extent to which risk of revision was related to specific covariates.
Multivariable logistic regression was used to analyse factors affecting
peri-operative mortality (<
90 days). A total of 4323 procedures
were studied. There were 80 patients who had undergone revision
surgery at the time of censoring (five-year revision rate 3.25%, 95%
confidence interval 2.44 to 4.07) and 137 patients (3.2%) patients
died within 90 days. After adjusting for patient and surgeon characteristics,
an increased risk of revision was associated with the use of cementless
prostheses compared with cemented (hazard ratio (HR) 1.33, p = 0.021).
Revision was independent of bearing surface and head size. The risk
of mortality within 90 days was significantly increased with higher
American Society of Anesthesiologists (ASA) grade (grade 3: odds
ratio (OR) 4.04, p <
0.001; grade 4/5: OR 20.26, p <
0.001;
both compared with grades 1/2) and older age (≥ 75 years: OR 1.65,
p = 0.025), but reduced over the study period (9% relative risk reduction
per year). THR is a good option in patients aged <
75 years and with
ASA 1/2. Cementation of the femoral component does not adversely
affect peri-operative mortality but improves survival of the implant
in the mid-term when compared with cementless femoral components.
There are no benefits of using head sizes >
28 mm or bearings other
than metal-on-polyethylene. More research is required to determine
the benefits of THR over hemiarthroplasty in older patients and
those with ASA grades >
2.
Modern metal-on-metal hip resurfacing has been
widely performed in the United Kingdom for over a decade. However,
the literature reports conflicting views of the benefits: excellent
medium- to long-term results with some brands in specific subgroups,
but high failure rates and local soft-tissue reactions in others.
The National Joint Registry for England and Wales (NJR) has collected
data on all hip resurfacings performed since 2003. This retrospective
cohort study recorded survival time to revision from a resurfacing
procedure, exploring risk factors independently associated with
failure. All patients with a primary diagnosis of osteoarthritis
who underwent resurfacing between 2003 and 2010 were included in
the analyses. Cox’s proportional hazard models were used to analyse
the extent to which the risk of revision was related to patient,
surgeon and implant covariates. A total of 27 971 hip resurfacings were performed during the
study period, of which 1003 (3.59%) underwent revision surgery.
In the final adjusted model, we found that women were at greater
risk of revision than men (hazard ratio (HR) = 1.30, p = 0.007),
but the risk of revision was independent of age. Of the implant-specific
predictors, five brands had a significantly greater risk of revision
than the Birmingham Hip Resurfacing (BHR) (ASR: HR = 2.82, p <
0.001,
Conserve: HR = 2.03, p <
0.001, Cormet: HR = 1.43, p = 0.001,
Durom: HR = 1.67, p <
0.001, Recap: HR = 1.58, p = 0.007). Smaller
femoral head components were also significantly more likely to require
revision (≤ 44 mm: HR = 2.14, p <
0.001, 45 to 47 mm: HR = 1.48,
p = 0.001) than medium or large heads, as were operations performed
by low-volume surgeons (HR = 1.36, p <
0.001). Once these influences
had been removed, in 4873 male patients <
60 years old undergoing
resurfacing with a BHR, the five-year estimated risk of revision
was 1.59%. In summary, after adjustment for a range of covariates we found
that there were significant differences in the rate of failure between
brands and component sizes. Younger male patients had good five-year
implant survival when the BHR was used.