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Bone & Joint Open
Vol. 2, Issue 1 | Pages 22 - 32
4 Jan 2021
Sprague S Heels-Ansdell D Bzovsky S Zdero R Bhandari M Swiontkowski M Tornetta P Sanders D Schemitsch E

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. HRQoL was assessed at hospital discharge (for pre-injury level) and at 12 months post-fracture using the Short Musculoskeletal Functional Assessment (SMFA) Dysfunction, SMFA Bother, 36-Item Short Form 36 (SF-36) Physical, and SF-36 Mental Component scores. We used multiple linear regression analysis to determine if baseline and surgical factors, as well as post-intervention procedures within one year of fracture, were associated with these HRQoL outcomes. Significance was set at p < 0.01. We hypothesize that, irrespective of the four measures used, prognosis is guided by both modifiable and non-modifiable factors and that patients do not return to their pre-injury level of function, nor HRQoL. Results. For patient and surgical factors, only pre-injury quality of life and isolated fracture showed a statistical effect on all four HRQoL outcomes, while high-energy injury mechanism, smoking, and race or ethnicity, demonstrated statistical significance for three of the four HRQoL outcomes. Patients who did not require reoperation in response to infection, the need for bone grafts, and/or the need for implant exchanges had statistically superior HRQoL outcomes than those who did require intervention within one year after initial tibial fracture nailing. Conclusion. We identified several baseline patient factors, surgical factors, and post-intervention procedures within one year after intramedullary nailing of a tibial shaft fracture that may influence a patient’s HRQoL. Cite this article: Bone Jt Open 2021;2(1):22–32


Bone & Joint Open
Vol. 4, Issue 4 | Pages 273 - 282
20 Apr 2023
Gupta S Yapp LZ Sadczuk D MacDonald DJ Clement ND White TO Keating JF Scott CEH

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 HRQoL comparison. The primary outcome was the difference in actual (TPF cohort) and expected (matched control) EQ-5D-3L score after TPF. Results. TPF patients had a significantly worse EQ-5D-3L utility (mean difference (MD) 0.09, 95% confidence interval (CI) 0.00 to 0.16; p < 0.001) following their injury compared to matched controls, and had a significant deterioration (MD 0.140, 95% CI 0 to 0.309; p < 0.001) relative to their preoperative status. TPF patients had significantly greater pre-fracture EQ-5D-3L scores compared to controls (p = 0.003), specifically in mobility and pain/discomfort domains. A decline in EQ-5D-3L greater than the minimal important change of 0.105 was present in 36/67 TPF patients (53.7%). Following TPF, OKS (MD -7; interquartile range (IQR) -1 to -15) and LEFS (MD -10; IQR -2 to -26) declined significantly (p < 0.001) from pre-fracture levels. Of the 12 elements of fracture care assessed, the most important to patients were getting back to their own home, having a stable knee, and returning to normal function. Conclusion. TPFs in older adults were associated with a clinically significant deterioration in HRQoL compared to preinjury level and age, sex, and deprivation matched controls for both undisplaced fractures managed nonoperatively and displaced or unstable fractures managed with internal fixation. Cite this article: Bone Jt Open 2023;4(4):273–282


The Bone & Joint Journal
Vol. 104-B, Issue 5 | Pages 633 - 639
2 May 2022
Costa ML Achten J Parsons NR

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, HRQoL, or the need for further surgery between patients treated with NPWT versus standard dressings at five years. Considering the combined results for all participants, there was a small but statistically significant change in DRI scores over time (1.6 units per year; p = 0.005), but no evidence that EQ-5D-3L scores changed significantly during years two to five (p = 0.551). Conclusion. This study shows that the high levels of disability and reduced HRQoL reported by patients 12 months after severe open fractures of the lower limb persist in the medium term, with little evidence of improvement between years two and five. Cite this article: Bone Joint J 2022;104-B(5):633–639


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_6 | Pages 12 - 12
1 Jun 2022
Wickramasinghe N Bayram J Hughes K Oag E Heinz N Dall G Ballantyne A Clement N
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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 HRQoL were recorded at the time of and for a timepoint 6-months prior to assessment. The study was powered to the EQ-5D (primary measure of HRQoL). There were 40 male and 46 female patients with a mean age of 68 (33 to 91) years; 65 patients were awaiting a THA and 21 a TKA. The mean waiting time was 372 (226 to 749) days. The EQ-5D index deteriorated by 0.222 (95%CI 0.164 to 0.280, p<0.001). The EQ-VAS also deteriorated by 10.8 (95%CI 7.5 to 14.0, p<0.001). CFS progressed from a median of 3 to 4 (p<0.001). The number of patients WTD increased from seven to 22 (p<0.001). Thirty-one(36%) patients felt their HRQoL was much worse and 28 (33%) felt it was somewhat worse. Patients waiting more than 6-months had a clinically significant deterioration in their HRQoL and demonstrated increasing level of frailty with more than a quarter living in a health state WTD


The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 394 - 400
1 Apr 2024
Kjærvik C Gjertsen J Stensland E Dybvik EH Soereide O

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 HRQoL, up to 36 months. The patients’ health and socioeconomic status were associated with the proportion of patients returning PROM data for analysis, and affected the results reported. Observed EQ-5D-3L scores are affected by attrition and selection bias mechanisms and motivate the use of statistical modelling for adjustment. Cite this article: Bone Joint J 2024;106-B(4):394–400


Bone & Joint Open
Vol. 3, Issue 3 | Pages 189 - 195
4 Mar 2022
Atwan Y Sprague S Slobogean GP Bzovsky S Jeray KJ Petrisor B Bhandari M Schemitsch E

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 HRQoL analysis, and those treated with NPWT had statistically significantly lower mean SF-12 PCS post-fracture (p < 0.001). These differences did not reach the minimally important difference for the SF-12 PCS. Conclusion. Our analysis found that patients treated with NPWT had higher odds of developing a deep infection requiring operative management within 12 months post-fracture. Due to possible residual confounding with the worst cases being treated with NPWT, we are unable to determine if NPWT has a negative effect or is simply a marker of worse injuries or poor access to early soft-tissue coverage. Regardless, our results suggest that the use of this treatment requires further evaluation. Cite this article: Bone Jt Open 2022;3(3):189–195


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_4 | Pages 4 - 4
8 Feb 2024
Oliver WM Bell KR Carter TH White TO Clement ND Duckworth AD Molyneux SG
Full Access

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 HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr


The Bone & Joint Journal
Vol. 98-B, Issue 4 | Pages 542 - 547
1 Apr 2016
Leonardsson O Rolfson O Rogmark C

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 HRQoL, residual pain or patient satisfaction. Take home message: The surgical approach for hemiarthroplasty does not seem to affect the patient-perceived HRQoL, residual pain or patient satisfaction one year after surgery on elderly patients. The choice of approach should be based on other factors, such as the risk of dislocation. Cite this article: Bone Joint J 2016;98-B:542–7


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_12 | Pages 3 - 3
1 Oct 2021
Farrow L Redmore J Talukdar P Ashcroft G
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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 HRQOL measure that generates single values for different combinations of health-states based upon how individuals compare x years of healthy living to x years of illness. We identified that those in Group1 had significantly greater improvement in post-operative EQ-5D TTO scores compared to Group2 (Median 0.67vs.0.19; p<0.0001 respectively), as well as greater improvement in OHS/OKS (Mean 22.4vs16.4; p<0.0001 respectively). Those in Group2 were significantly less likely to achieve EQ-5D MCID attainment (OR 0.13, 95%CI 0.07–0.23; p<0.0001) with a trend towards lower OHS/OKS MCID attainment (OR 0.66, 95%CI 0.37–1.19; p=0.168). There was no statistically significant difference in adverse events. These finding suggest that a pre-operative EQ-5D cut-off of ≤0.487 for hip and knee arthroplasty prioritisation may help to maximise clinical utility and cost-effectiveness in a limited resource setting post COVID-19


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 1 | Pages 68 - 75
1 Jan 2005
Miedel R Ponzer S Törnkvist H Söderqvist A Tidermark J

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 HRQOL. The reduction in the HRQOL (EQ-5D. index. score) was significant in both groups compared with that before the fracture (p < 0.005). Our findings indicate that the SGN showed good results in both trochanteric and subtrochanteric fractures. The limited number of intra-operative femoral fractures did not influence the outcome or the need for revision surgery. Moreover, the SGN group had a reduced number of serious general complications and wound infections compared with the MSP group. The MSP in the biaxial dynamisation mode had a low rate of failure in trochanteric fractures but an unacceptably high rate when used in the biaxial dynamisation mode in subtrochanteric fractures. The negative influence of an unstable trochanteric or subtrochanteric fracture on the quality of life was significant regardless of the surgical method


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_16 | Pages 52 - 52
1 Apr 2013
Goldhahn S Sawaguchi T
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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 HRQoL answers between old Japanese patients and their close relatives. Materials and methods. In a clinical study about trochanteric fractures, HRQoL was assessed using the SF36v2. A sample of 27 questionnaires were completed via telephone interview twice on the same day: once by the patients themselves, and once by a close relative. Assessments were performed at either 6 or 12 mo after surgery. The reliability of the SF36v2 dimensions and of the 2 component summary measures was assessed by Intraclass Correlation Coefficients. Results. The mean difference in responses between patients and relatives ranged from 0 (95%CI 0;0) for Social Functioning (SF) and Role-Emotional (RE) to 1.1 (95%CI-0.4;2.6) for Mental Health. Strong correlation between assessments by patients and those by their proxies ranging from 0.878 (95%CI 0.751;0.943) for vitality to 1.000 (95%CI 1.000;1.000) for SF and RE was found for all eight dimension scores and the two component summary measures. Discussion. Proxy answers from Japanese relatives of elderly patients with hip fractures regarding HRQoL seem reliable and might be used for quality-of-life reporting when patients cannot answer for themselves


Bone & Joint Open
Vol. 3, Issue 7 | Pages 566 - 572
18 Jul 2022
Oliver WM Molyneux SG White TO Clement ND Duckworth AD

Aims

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.

Methods

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 4 | Pages 523 - 529
1 Apr 2005
Blomfeldt R Törnkvist H Ponzer S Söderqvist A Tidermark J

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 HRQOL even before the fracture. The EQ-5D. index. score was significantly worse in the hemiarthroplasty group compared with the internal fixation group at the final follow-up (p < 0.001). In our opinion, there is little to recommend hemiarthroplasty with an uncemented Austin Moore prosthesis compared with internal fixation, in patients with severe cognitive dysfunction


Bone & Joint Research
Vol. 3, Issue 3 | Pages 69 - 75
1 Mar 2014
Parsons N Griffin XL Achten J Costa ML

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 HRQOL tool such as EQ-5D could be used to measure outcome for patients recovering from hip fracture, including those with cognitive impairment. Cite this article: Bone Joint Res 2014;3:69–75


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 157 - 167
1 Jan 2022
Makaram NS Goudie EB Robinson CM

Aims

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.

Methods

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

We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial.

Methods

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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 425 - 425
1 Sep 2012
Rolfson O Kärrholm J Dahlberg L Garellick G
Full Access

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 HRQoL (p<0,001). Patients' response rates to the Registry was 86% pre-operatively and 90% one year post-operatively. Nationwide implementation of a PROM programme requires a structured organization and effective IT solutions. The continuous collection of PROs permits local and national improvement work and allows for further health-economic evaluation


Aims

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.

Methods

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.


The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1072 - 1081
1 Aug 2020
Png ME Madan JJ Dritsaki M Achten J Parsons N Fernandez M Grant R Nanchahal J Costa ML

Aims

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.

Methods

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.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1526 - 1532
1 Nov 2017
Tarride JE Hopkins RB Blackhouse G Burke N Bhandari M Johal H Guyatt GH Busse JW

Aims

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.

Patients and Methods

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.