Aims. Using tibial shaft fracture participants from a large, multicentre randomized controlled trial, we investigated if patient and surgical factors were associated with health-related quality of life (HRQoL) at one year post-surgery. Methods. The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) trial examined adults with an open or closed tibial shaft fracture who were treated with either reamed or unreamed intramedullary nails.
Aims. To investigate health-related quality of life (HRQoL) of older adults (aged ≥ 60 years) after tibial plateau fracture (TPF) compared to preinjury and population matched values, and what aspects of treatment were most important to patients. Methods. We undertook a retrospective, case-control study of 67 patients at mean 3.5 years (SD 1.3; 1.3 to 6.1) after TPF (47 patients underwent fixation, and 20 nonoperative management). Patients completed EuroQol five-dimension three-level (EQ-5D-3L) questionnaire, Lower Limb Function Scale (LEFS), and Oxford Knee Scores (OKS) for current and recalled prefracture status. Propensity score matching for age, sex, and deprivation in a 1:5 ratio was performed using patient level data from the Health Survey for England to obtain a control group for
Aims. The aim of this study was to report the outcomes of patients with severe open fractures of the lower limb in the five years after they took part in the Wound management for Open Lower Limb Fracture (WOLLF) trial. Methods. The WOLLF trial compared standard dressings to negative pressure wound therapy (NPWT) applied at the end of the first surgical wound debridement, and patients were followed-up for 12 months. At 12 months, 170 of the original 460 participants agreed to take part in this medium-term follow-up study. Patients reported their Disability Rating Index (DRI) (0 to 100, where 100 is total disability) and health-related quality of life (HRQoL) using the EuroQol five-dimension three-level health questionnaire (EQ-5D-3L) annually by self-reported questionnaire. Further surgical interventions related to the open fracture were also recorded. Results. There was no evidence of a difference in patient-reported disability,
The primary aim was to assess whether patients waiting 6-months or more for a total hip (THA) or knee (KA) arthroplasty had a deterioration in their health-related quality of life (HRQoL). Secondary aims were to assess change in level of frailty and the number living in a state worse than death (WTD). Eight-six patients waiting for a primary TKA or KA for more than 6-months were selected at random from waiting lists in three centres. Patient demographics, waiting time, EuroQol 5-dimension (EQ-5D) and visual analogue scores (EQ-VAS), Rockwood clinical frailty score (CFS) and SF-36 subjective change in
Aims. The aims of this study were to assess quality of life after hip fractures, to characterize respondents to patient-reported outcome measures (PROMs), and to describe the recovery trajectory of hip fracture patients. Methods. Data on 35,206 hip fractures (2014 to 2018; 67.2% female) in the Norwegian Hip Fracture Register were linked to data from the Norwegian Patient Registry and Statistics Norway. PROMs data were collected using the EuroQol five-dimension three-level questionnaire (EQ-5D-3L) scoring instrument and living patients were invited to respond at four, 12, and 36 months post fracture. Multiple imputation procedures were performed as a model to substitute missing PROM data. Differences in response rates between categories of covariates were analyzed using chi-squared test statistics. The association between patient and socioeconomic characteristics and the reported EQ-5D-3L scores was analyzed using linear regression. Results. The median age was 83 years (interquartile range 76 to 90), and 3,561 (10%) lived in a healthcare facility. Observed mean pre-fracture EQ-5D-3L index score was 0.81 (95% confidence interval 0.803 to 0.810), which decreased to 0.66 at four months, to 0.70 at 12 months, and to 0.73 at 36 months. In the imputed datasets, the reduction from pre-fracture was similar (0.15 points) but an improvement up to 36 months was modest (0.01 to 0.03 points). Patients with higher age, male sex, severe comorbidity, cognitive impairment, lower income, lower education, and those in residential care facilities had a lower proportion of respondents, and systematically reported a lower health-related quality of life (HRQoL). The response pattern of patients influenced scores significantly, and the highest scores are found in patients reporting scores at all observation times. Conclusion. Hip fracture leads to a persistent reduction in measured
Aims. To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures. Methods. Patients from the Fluid Lavage in Open Fracture Wounds (FLOW) trial with Gustilo-Anderson grade II or III open fractures within the lower limb were included in this secondary analysis. Using mixed effects logistic regression, we assessed the impact of NPWT on deep wound infection requiring surgical intervention within 12 months post-injury. Using multilevel model analyses, we evaluated the impact of NPWT on the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12) at 12 months post-injury. Results. After applying inverse probability treatment weighting to adjust for the influence of injury characteristics on type of dressing used, 1,322 participants were assessed. The odds of developing a deep infection requiring operative management within 12 months of initial surgery was 4.52-times higher in patients who received NPWT compared to those who received a standard wound dressing (95% confidence interval (CI) 1.84 to 11.12; p = 0.001). Overall, 1,040 participants were included in our
This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture. 70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL). At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups. Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and
Aims. Hemiarthroplasty of the hip is usually carried out through either
a direct lateral or posterior approach. The aim of this prospective
observational study was to determine any differences in patient-reported
outcomes between the two surgical approaches. . Patients and Methods. From the Swedish Hip Arthroplasty Register we identified patients
of 70 years and above who were recorded as having had a hemiarthroplasty
during 2009. Only patients who had been treated with modern prostheses
were included. A questionnaire was posted to those who remained
alive one year after surgery. A total of 2118 patients (78% of those
available) with a mean age of 85 years (70 to 102) returned the
questionnaire. . Results. Patients who had undergone surgery through a posterior approach
reported a higher health-related quality of life (HRQoL, EQ-5D mean
0.52 versus 0.47, p = 0.009), less pain (visual
analogue scale mean 17 versus 19, p = 0.02) and greater
satisfaction with the result of surgery (visual analogue scale mean
22 versus 24, p = 0.02) than those who had a direct
lateral approach. However, after adjusting for age, gender, cognitive
impairment and American Society of Anesthesiologists grade, no association
was found between surgical approach and
One potential approach to addressing the current hip and knee arthroplasty backlog is via adoption of surgical prioritisation methods, such as use of pre-operative health related quality of life (HRQOL) assessment. We set out to determine whether dichotomization using a previously identified bimodal EuroQol Five-Dimension (EQ-5D) distribution could be used to triage waiting lists. 516 patients had data collected regarding demographics, perioperative variables and patient reported outcome measures (pre-operative & 1-year post-operative EQ-5D-3L and Oxford Hip and Knee Scores (OHS/OKS). Patients were split into two equal groups based on pre-operative EQ-5D Time Trade-Off (TTO) scores and compared (Group1 [worse HRQOL] = −0.239 to 0.487; Group2 [better HRQOL] = 0.516 to 1 (best)). The EQ5D TTO is a widely used and validated
We studied 217 patients with an unstable trochanteric or subtrochanteric fracture who had been randomly allocated to treatment by either internal fixation with a standard Gamma nail (SGN) or a Medoff sliding plate (MSP, biaxial dynamisation mode). Their mean age was 84 years (65 to 99) and they were reviewed at four and 12 months after surgery. Assessments of outcome included general complications, technical failures, revision surgery, activities of daily living (ADL), hip function (Charnley score) and the health-related quality of life (HRQOL, EQ-5D). The rate of technical failure in patients with unstable trochanteric fractures was 6.5% (6/93) (including intra-operative femoral fractures) in the SGN group and 5.2% (5/96) in the MSP group. In patients with subtrochanteric fractures, there were no failures in the SGN group (n = 16) and two in the MSP group (n = 12). In the SGN group, there were intra-operative femoral fractures in 2.8% (3/109) and no post-operative fractures. There was a reduced need for revision surgery in the SGN group compared with the MSP group (8.3%; 9/108; p = 0.072). The SGN group also showed a lower incidence of severe general complications (p <
0.05) and a trend towards a lower incidence of wound infections (p = 0.05). There were no differences between the groups regarding the outcome of ADL, hip function or the
Introduction. Proxy assessment of health-related quality of life (HRQoL) can be an alternative to self reporting in elderly patients with cognitive or physical impairment. However, over- and underestimation by the proxies is reported. The aim of the present study was to examine the agreement of
We studied 60 patients with an acute displaced fracture of the femoral neck and with a mean age of 84 years. They were randomly allocated to treatment by either internal fixation with cannulated screws or hemiarthroplasty using an uncemented Austin Moore prosthesis. All patients had severe cognitive impairment, but all were able to walk independently before the fracture. They were reviewed at four, 12 and 24 months after surgery. Outcome assessments included complications, revision surgery, the status of activities of daily living (ADL), hip function according to the Charnley score and the health-related quality of life (HRQOL) according to the Euroqol (EQ-5D) (proxy report). General complications and the rate of mortality at two years (42%) did not differ between the groups. The rate of hip complications was 30% in the internal fixation group and 23% in the hemiarthroplasty group; this was not significant. There was a trend towards an increased number of re-operated patients in the internal fixation group compared with the hemiarthroplasty group, 33% and 13%, respectively (p = 0.067), but the total number of surgical procedures which were required did not differ between the groups. Of the survivors at two years, 54% were totally dependent in ADL functions and 60% were bedridden or wheelchair-bound regardless of the surgical procedure. There was a trend towards decreased mobility in the hemiarthroplasty group (p = 0.066). All patients had a very low
Objectives. To study the measurement properties of a joint specific patient
reported outcome measure, a measure of capability and a general
health-related quality of life (HRQOL) tool in a large cohort of
patients with a hip fracture. Methods. Responsiveness and associations between the Oxford Hip Score
(a hip specific measure: OHS), ICEpop CAPability (a measure of capability
in older people: ICECAP-O) and EuroQol EQ-5D (general health-related
quality of life measure: EQ-5D) were assessed using data available
from two large prospective studies. The three outcome measures were assessed
concurrently at a number of fixed follow-up time-points in a consecutive
sequence of patients, allowing direct assessment of change from
baseline, inter-measure associations and validity using a range
of statistical methods. Results. ICECAP-O was not responsive to change. EQ-5D was responsive to
change from baseline, with an estimated standardised effect size
for the two datasets of 0.676 and 0.644 at six weeks and four weeks
respectively; this was almost as responsive to change as OHS (1.14 at
four weeks). EQ-5D correlated strongly with OHS; Pearson correlation
coefficients were 0.74, 0.77 and 0.70 at baseline, four weeks and
four months. EQ-5D is a moderately good predictor of death at 12
months following hip fracture. Furthermore, EQ-5D reported by proxies
(relatives and carers) behaves similarly to self-reported scores. Conclusions. Our findings suggest that a general
The primary aim was to estimate the cost-effectiveness of routine operative fixation for all patients with humeral shaft fractures. The secondary aim was to estimate the health economic implications of using a Radiographic Union Score for HUmeral fractures (RUSHU) of < 8 to facilitate selective fixation for patients at risk of nonunion. From 2008 to 2017, 215 patients (mean age 57 yrs (17 to 18), 61% female (n = 130/215)) with a nonoperatively managed humeral diaphyseal fracture were retrospectively identified. Union was achieved in 77% (n = 165/215) after initial nonoperative management, with 23% (n = 50/215) uniting after surgery for nonunion. The EuroQol five-dimension three-level health index (EQ-5D-3L) was obtained via postal survey. Multiple regression was used to determine the independent influence of patient, injury, and management factors upon the EQ-5D-3L. An incremental cost-effectiveness ratio (ICER) of < £20,000 per quality-adjusted life-year (QALY) gained was considered cost-effective.Aims
Methods
Open reduction and plate fixation (ORPF) for displaced proximal humerus fractures can achieve reliably good long-term outcomes. However, a minority of patients have persistent pain and stiffness after surgery and may benefit from open arthrolysis, subacromial decompression, and removal of metalwork (ADROM). The long-term results of ADROM remain unknown; we aimed to assess outcomes of patients undergoing this procedure for stiffness following ORPF, and assess predictors of poor outcome. Between 1998 and 2018, 424 consecutive patients were treated with primary ORPF for proximal humerus fracture. ADROM was offered to symptomatic patients with a healed fracture at six months postoperatively. Patients were followed up retrospectively with demographic data, fracture characteristics, and complications recorded. Active range of motion (aROM), Oxford Shoulder Score (OSS), and EuroQol five-dimension three-level questionnaire (EQ-5D-3L) were recorded preoperatively and postoperatively.Aims
Methods
In medical research and among health-care providers there has been a marked shift to a focus on patient-reported outcome (PRO) and how it is measured and analysed. In this study from the Swedish Hip Arthroplasty Register we present the development and results of a nationwide, prospective, observational follow-up programme including patient-reported outcome measures (PROMs). The programme started in 2002 and has gradually expanded to include all units performing THA surgery in Sweden. The self-administered PROM protocol comprises the EQ-5D instrument, the Charnley categorization and visual analogue scales (VAS) for pain and satisfaction. These current analyses include 34 960 THAs with complete pre- and one-year postoperative questionnaires. Patients eligible for THA generally report low health-related quality of life (HRQoL) and suffer from pain. One year post-operatively the mean EQ-5D index increased from 0.41 to 0.78 (p<0.001) which is above the level of an age- and gender-matched population. Pain was reduced from mean VAS 62 to 14 (p<0.001). Females, younger patients and those with Charnley category C reported lower EQ-5D index pre-operatively than males, older patients and Charnley A or B, respectively, did (all p<0.001). In a multivariable regression analysis Charnley category C, male gender and higher age were associated with less improvement in
We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial. HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months.Aims
Methods
This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial. The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.Aims
Methods
To compare the cost-utility of standard dressing with incisional negative-pressure wound therapy (iNPWT) in adults with closed surgical wounds associated with major trauma to the lower limbs. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective based on data collected from the Wound Healing in Surgery for Trauma (WHiST) multicentre randomized clinical trial. Health resource utilization was collected over a six-month post-randomization period using trial case report forms and participant-completed questionnaires. Cost-utility was reported in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was conducted to test the robustness of cost-effectiveness estimates while uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves.Aims
Methods
This 501-patient, multi-centre, randomised controlled trial sought
to establish the effect of low-intensity, pulsed, ultrasound (LIPUS)
on tibial shaft fractures managed with intramedullary nailing. We
conducted an economic evaluation as part of this trial. Data for patients’ use of post-operative healthcare resources
and time taken to return to work were collected and costed using
publicly available sources. Health-related quality of life, assessed
using the Health Utilities Index Mark-3 (HUI-3), was used to derive
quality-adjusted life years (QALYs). Costs and QALYs were compared
between LIPUS and control (a placebo device) from a payer and societal
perspective using non-parametric bootstrapping. All costs are reported
in 2015 Canadian dollars unless otherwise stated.Aims
Patients and Methods