We aimed to quantify the health related quality of life in a series of patients suffering a variety of different tibial injuries. Patients with previous tibial injury, randomly selected from our trauma database, who successfully completed their entire course of treatment at our institution, were recalled for final assessment. Mean time to final follow-up was 37.4 months. Statistical analysis was performed using SPSS computer software. Overall, 130 patients were evaluated. There was no significant difference in the self-care dimension between the groups. Psychological problems were common in patients with IIIb and IIIc fractures, as well as amputees, with the highest incidence in those with IIIc fractures. Patients who had undergone amputation and those with IIIb open fractures reported problems with mobility significantly more frequently than those who had IIIc type injuries. However, this could be partially attributed to the significant difference in mean age between groups, with patients sustaining IIIc injuries being younger (31.9 vs 46.9). Patients with IIIb and IIIc type fractures reported significantly more problems with pain compared with those who had undergone amputation. Interestingly, patients who had undergone fasciotomy reported pain as frequently as amputees. Regarding the VAS, only patients with closed fractures reported significantly different scores from the mean of all the other groups. These data represent the health related quality of life of patients having suffered the full spectrum of tibial injury and should be considered when determining the treatment options for these patients

To compare preoperative and postoperative Health Related Quality of Life (HRQoL) scores in operated Adolescent Idiopathic Scoliosis (AIS) patients with and without concomitant isthmic spondylolisthesis. A retrospective study of a prospective cohort of 464 individuals undergoing AIS surgery between 2008 and 2018 was performed. All patients undergoing surgery for AIS with a minimum 2-year follow-up were included. We excluded patients with prior or concomitant surgery for spondylolisthesis. HRQoL scores were measured using the SRS-22 questionnaire. Comparisons were performed between AIS patients with vs. without concomitant spondylolisthesis treated non-surgically. AIS surgery was performed for 36 patients (15.2 ±2.5 y.o) with concomitant isthmic spondylolisthesis, and 428 patients (15.5 ±2.4 y.o) without concomitant spondylolisthesis. The two groups were similar in terms of age, sex, preoperative and postoperative Cobb angles. Preoperative and postoperative HRQoL scores were similar between the two groups. HRQoL improved significantly for all domains in both groups, except for pain in patients with spondylolisthesis. There was no need for surgical treatment of the spondylolisthesis and no slip progression during the follow-up duration after AIS surgery. Patients undergoing surgical treatment of AIS with non-surgical management of a concomitant isthmic spondylolisthesis can expect improvement in HRQoL scores, similar to that observed in patients without concomitant spondylolisthesis

Acute Haematogenous Osteomyelitis (AHO) remains a cause of severe illness among children with the possibility of long-term consequences for growth and development. Previous research on sequelae from AHO rarely considers outcomes more than two years following treatment. This study aims to establish the quality of life of patients diagnosed with AHO in childhood up to 13 years after diagnosis, evaluating the impact on social, emotional, physical, and school function. Children treated for AHO between 2008–2018 at a tertiary referral centre in New Zealand were identified. PedsQL™ questionnaires were conducted via phone with either the child or primary caregiver and responses analysed. 40 patients met inclusion criteria, were contactable by phone, and consented to participate. The mean age was 7 years (range 0–15) and most were female (60%). Health related quality of life (HRQOL) was scored as a percentage with most participants scoring >80% (n=27). Those who do experience reduced quality of life following treatment for AHO were likely to complain of pain, stiffness, or anxiety. The impact of significant childhood illness on mental health was not adequately captured by the PedsQL™ but was highlighted in qualitative feedback. We conclude that the majority of children treated for AHO reported excellent health-related quality of life up to 13 years following treatment although an negative impact on mental health was reported using qualitative analysis. A refined scoring system is needed to assess the long-term impact of musculoskeletal infection

Abstract. Introduction. We aimed to compare the outcomes of elderly patients with periarticular distal femur or supracondylar periprosthetic fractures treated with either open reduction internal fixation or distal femoral replacement. Methods. A retrospective review of patients over 65 years with AO Type B and C fractures of the distal femur or Su type I and II periprosthetic fractures treated with either a DFR or ORIF was undertaken. Outcomes including Length of Stay, PROMs (Oxford Knee Score and EQ 5D), infection, union, mortality, complication and reoperation rates were assessed. Data on confounding variables were also collected for multivariate analysis. Patients below 65 years and extra articular fractures were excluded. Results. 23 patients (11 in DFR group and 12 in ORIF group) fulfilled inclusion criteria and were included in the analysis. There was no difference between the DFR and ORIF groups with respect to SDI, demographic variables, ASA grade, FCI, preoperative Hb and renal function. There was no difference in 30 day mortality, reoperation rates, 30 day readmission rates and LOS between the two groups. Mean follow up was 12.7 and 15.9 months respectively in the DFR and ORIF groups. At final follow up after accounting for all confounding variables on multivariate analysis, functional outcomes using OKS (adjusted mean: 29.5 vs 15.8) and Health related Quality of Life outcomes using EQ 5D (adjusted mean: 0.453 vs −0.07) were significantly better in the DFR group. Conclusion. DFR for periarticular and periprosthetic distal femoral fractures in the elderly are associated with better patient reported outcomes

Introduction. Open fractures are complex injuries associated with substantial morbidity. These injuries are associated with harm to both physical and emotional health as well as preclusion of work, social, and leisure activities. Patient reported outcome measures (PROMs) and health related quality of life are critical indicators of successful rehabilitation following open fracture treatment. This study aimed to measure the PROMs for patients with open lower limb fractures and investigate the relationship with injury severity. Materials & Methods. A retrospective cohort study was performed at a single major trauma centre in the UK. All adult patients with an open lower limb fracture were eligible for inclusion. Patients were identified through a search of a local Open Fracture Database. Epidemiological, clinical, and fracture classification data were obtained by reviewing case notes. Lower Extremity Function Scale (LEFS) and EQ5-D were used as PROMs and measured by a postal questionnaire, alongside return to employment data. Results. A total of 73 patients responded to the questionnaire. Median LEFS was 42 (IQR 26.5 – 59.5), and median EQ5-D was 0.69 (IQR 0.48 – 0.89). There was no significant association between open fracture classification and PROMs. Over 40% of patients reported a change in employment due to their injury. Those who changed jobs had a statistically significant reduction in the EQ5-D of 0.12 (p = 0.021); no significant difference existed in LEFS. Conclusions. This study demonstrates the devastating functional impact of open fractures. This cohort of open injuries reported lower functional and quality-of-life measures compared to population norms. Injury classification was not a valuable predictor of PROMs. A substantial proportion of patients were forced to change employment due to their injury, and these patients reported a significantly lower quality of life. Further work is required to understand the factors contributing to open fracture PROMs

A huge commitment is required from patients and families who undergo a limb reconstruction procedure using the hexapod frame. This includes turning the struts on the frame, pin site care and intensive rehabilitation. Montpetit et al (2009) discovered that function, participation, engagement in regular activities of daily living is severely impacted during the hexapod lengthening period. Due to the long duration and burden for families, it is imperative that healthcare professionals understand the impact that the hexapod frame has on functional abilities and health related quality of life (HRQL). This project involved a retrospective review of prospectively collected data on function and HRQL during two periods of time: (1) when the hexapod frame is applied on the child's lower extremity and (2) when the lengthening phase is completed, and the hexapod frame is removed. Data from 38 children (mean age: 12 years SD 3.8) who completed lower extremity reconstruction using the hexapod frame and completed either or both the Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL) and Pediatric Outcomes data Collection Instrument (PODCI) was included. Analysis included, standardized response means, the non-parametric Wilcoxon test and effect size calculation. A Wilcoxon signed rank test for those children who completed pre and post frame PODCI’;s revealed those scores were significantly greater once the hexapod frame was removed (Md=85.10, n=10) compared to during (Md=66.50, n=10) with a large effect size, r= 1.45. Similar, the PedsQL scores improved post frame removal (Md= 66.30, n=10) compared to during treatment (Md = 53.34, n=10), with a medium size effect, r= 0.62. All subtests improved once the frame was removed. This study provides essential insights into the burden of the hexapod frame for children and provides valuable information for all allied healthcare professionals targeted interventions for health domains. This study shows that children's function improves once the hexapod frame is removed. However, this study highlights the importance for all healthcare professional to address health domains for the duration of the hexapod procedure where the child scored lower e.g. sports and physical function, pain and comfort, happiness from the PODCI. The PedsQL identified lower mean scores in physical and emotional function

Periprosthetic joint infection is a significant complication of total hip arthroplasty. The PRSThesis of Antibiotic Loaded Acrylic Cement (PROSTALAC) system can improve health related quality of life during a two step treatment approach for infection resolution. We investigated quality of life with the PROSTALAC in situ and also compared subjects who underwent second stage surgery with those who retained the PROSTALAC on a long term basis. Twenty nine subjects were enrolled pre-PROSTALAC insertion, recording demographics, physical demand level and comorbidities. Subjects were then followed out to 24 months with either the PROSTALAC in situ or post revision for those who underwent the second stage surgery. Quality of life was evaluated using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and RAND 36-Item Health Survey (RAND-36). Infection resolution was also determined for all subjects enrolled. Three subjects died and 22/26 (84%) completed the evaluation. Overall 26 (85%) infections resolved. Following PROSTALAC insertion, WOMAC pain and function scores improved within three to six months and did not change out to 24 months. Physical function, bodily pain and vitality also significantly improved within three to six months postoperatively. Only seven (32%) subjects underwent second stage surgery. These individuals were more likely to be high demand (p=0.03) and trended towards being younger, male, with fewer comorbidities and lower BMI (p<0.10). There was no difference in WOMAC scores at 24 months between those who underwent second stage revisions and those who retained the PROSTALAC. The use of a PROSTALAC implant improves health related quality of life. Long term retention of the PROSTALAC implant may be appropriate for low demand patients and considered for potentially high risk surgical candidates

Purpose. Successful outcome after opening wedge high tibial osteotomy (HTO) has been correlated with obtaining and maintaining angular correction while achieving union. Magnitude of correction, type of fixation and use of bone graft have been implicated as variables which can affect maintenance of correction. The purpose of this study was to determine whether loss of coronal plane correction occurs over time following opening wedge HTO using our standard surgical techniques (unlocked plate with allograft). Our aim was also to correlate clinical outcome measures and radiographic findings. Our hypothesis was that no significant loss of correction would occur. Method. We conducted a retrospective case series with prospectively obtained clinical and radiographic follow-up. The study population was drawn from surgical data bases of 4 fellowship trained surgeons and included all patients who underwent opening wedge HTO between 2007 and 2009, allowing a minimum of 1 year follow-up. Chart data collected included the model and size of opening wedge fixation plate, type of bone graft, concomitant procedures performed as well as patient factors such as smoking status, medical co-morbidities and body mass index (BMI). Patients underwent follow-up including documentation of complications and physical examination for range of motion and stability. Outcome scores obtained included the validated, disease-specific KOOS score (5 domains measured out of 100) and the SF-36 as a validated assessment of health related quality of life (8 domains averaged and reported using norm based scoring with population mean = 50). Full length weight bearing X-rays were obtained and measured and then compared with pre-operative and early post-operative X-rays. Measurements were performed with PACS digital imaging software. Results. Forty-one patients with 44 osteotomies were identified as being eligible for the study. Ten patients were lost to follow-up and 7 patients (8 knees) did not agree to participate in prospective evaluation. The total study population with complete retrospective and prospective data included 24 patients with 26 knees. Complications occurred in 4 cases (15%) with 2 patients who developed superficial infections treated with antibiotics and wound care. Two patients developed deep infections requiring multiple additional procedures. One additional patient underwent plate removal. All osteotomies united. No loss of significant loss of coronal plane correction occurred. Mean alignment was 1.1 degrees of mechanical valgus. Mean KOOS (pain) was 78.9 and SF-36 was 50.7. Conclusion. Our results demonstrate that no significant loss of correction occurred in our series after opening wedge HTO using unlocked plates and either allograft or no bone graft. Successful clinical and radiographic outcomes were demonstrated with mean health related quality of life scores equal to population norms. Patients with BMI < 30 and those who did not develop infections had superior results

Currently 180 days is the target maximum wait time set by all Canadian provinces for elective joint replacement surgery. In Nova Scotia however, only 34% of Total Knee Arthroplasties (TKA) and 51% of Total Hip Arthroplasties (THA) met this benchmark in 2017. Surgery performed later in the natural history of disease is shown to have significant impact on pain, function and Health related Quality of Life at the time of surgery and potentially affect post-operative outcomes. The aim of this study is to describe the association between wait time and acute hospital Length of Stay (LOS) during elective hip and knee arthroplasty in province of Nova Scotia. Secondarily we aim to describe risk factors associated with variations in LOS. Data from Patient Access Registry Nova Scotia (PAR-NS) was linked to the hospital Discharge Access Database (DAD) for primary hip and knee arthroplasty spanning 2009 to 2017. There were 23,727 DAD observations and 21,329 PARNS observations identified. Observations were excluded based on missing variables, missing linkages, revision status and emergency cases. Percentage difference in LOS, risk factors and outcomes were analyzed using Poisson regression for those waiting more than 180 days compared to those waiting equal or less than 180 days. For primary TKA, 11,833 observations were identified with mean age of 66 years, mean wait time of 348 days and mean LOS of 3.6 days. After adjusting for controls, patients waiting more than 180 days for elective TKA have a 2.5% longer acute care LOS (p < 0.028). Risk factors identified for prolonged LOS are advanced age, female gender, higher surgical priority indicator, required blood transfusion, dementia, peptic ulcer disease, cerebrovascular disease, heart failure, chronic kidney disease, malignancy, ischemic heart disease and diabetes. Factors associated with decreased LOS are surgical year, use of local anesthetic, peripheral location of hospital and admission to hospital from home. For primary THA, 6626 observations were identified with mean age of 66 years, mean wait time of 267 days and mean LOS of 4 days. Patients waiting more than 180 days for THA did not show a statistically significant association with LOS. Risk factors and protective factors are the same with exception of CVD and use of local anesthetic. Our findings suggest a positive and statistically significant association for patients waiting more than 180 days for TKA and longer acute care LOS. Longer LOS may be due to deteriorating health status while placed on a surgical waitlist and may represent a delayed and indirect cost to the patient and the healthcare system. Ultimately with projected increase in demand for elective joint replacement surgeries, our findings are aimed to inform physicians and policy makers in management of surgical waitlist efficiency and cost effectiveness. For any reader inquiries, please contact . shahriar-s@hotmail.com

This study explored psychological functioning and coping styles in adult patients with localized and metastatic extremity soft-tissue sarcoma (STS) from diagnosis through survivorship in a single expert sarcoma center in Canada. Our analyses were driven by three main goals: 1) to develop a better understanding of the affective responses and coping mechanisms in patients who face this rare illness, 2) to identify areas of psychological functioning in which patients with STS experience most difficulties, and 3) to describe how these areas could be best addressed in clinical settings. This descriptive qualitative study is a part of a larger mixed-methods study on health related quality of life (HRQoL) in adult patients with soft-tissue sarcoma treated between 2003 and 2018. Purposive sampling based on demographic and disease variables from all patients within a prospective database was utilized to ensure a representative patient population. Three formats of data collection were conducted in French and English, 2 online focus groups (total n=12), 2 in-person focus groups (total n=12), as well as individual semi-structured interviews (n=4). Data was analyzed using inductive thematic networks approach using the qualitative software N-Vivo 12. Codes were generated by 2 independent qualitative experts that captured key concepts referring to psychological functioning and coping mechanisms. Basic themes were clustered into organizing themes, which were later merged into a global theme. Attention was paid to deviant cases, and within-group dynamics during focus group discussion analysis. Any discrepancies or inconsistencies in coding were resolved in a consensus meeting. The final sample size was determined when data saturation was reached, and no new themes emerged. Our analyses of psychological well-being and functioning revealed three main themes, mood, anxiety, and body image concerns. Feelings of depression and low mood were prominent, coinciding with physical symptoms and limitations especially during the phase of treatment and recovery. Women were more likely to report emotional volatility, while men tended to report more preoccupation. Loss of control and independence, anxiety related to illness recurrence, uncertainty about the future and facing one's mortality significantly impacted quality of life. Furthermore, while patients were more concerned with limb functionality, disfigurement and self-consciousness featured prominently in the narrative. Four adaptive coping styles were observed, positive reframing and optimism, finding a purpose, being proactive, and using humor. Among the maladaptive strategies, we noted passive acceptance, and avoidance and denial. Psychological well-being is an important domain in the HRQoL of adult patients with extremity STS. Physicians and medical workers should encourage adaptive coping mechanisms such as positive reframing and optimism. Patients endorsing higher levels of psychological distress and maladaptive coping styles should be monitored for their well-being and multidisciplinary strategies employed to optimize psychological function and HRQoL

Hip displacement is the second most common deformity in children with cerebral palsy (CP). A displaced, and particularly a dislocated hip, can have significantly adverse effects on an individual. Surgical intervention to correct progressive hip displacement or dislocation is recommended for children with CP. Success of surgical intervention is often described using radiological outcomes. There is evidence that surgical treatment for displaced or dislocated hips decreases pain and hip stiffness and improves radiological outcomes. However, there is no information in the literature regarding the impact of surgical treatment on the health related quality of life (HRQOL) in these children. The aim of our study was to examine the impact of surgical treatment of hip displacement or dislocation on HRQOL in children with CP. This prospective longitudinal cohort study involved children attending a tertiary care hospital orthopaedic department. Children with CP between the ages of 4 and 18 years, with hip displacement/dislocation, defined as a Reimer's migration percentage (MP) of >40% on a pre-operative x-ray, and undergoing surgical reconstruction were eligible for inclusion. Quality of life was measured pre-operatively and post-operatively using the CPCHILD Questionnaire. Twelve patients (one child was GMFCS level III, 4 were level IV, and 7 were level V), aged 4.0 to 17.3 years, were assessed pre-operatively and then again at least six months post-operatively. All underwent unilateral (5) or bilateral (7) reconstructive hip surgery. The migration percentage of hips undergoing reconstruction was reduced by an average of 52% (9–100%). The average change in CPCHILD score showed an increase of 6.4 points [95% CI: −1.4–14.2]. In this pilot study, no significant change was noted in HRQOL following reconstructive hip surgery, despite a marked reduction in Reimer's MP. However, only 4 of 12 parents reported that their child had daily pain pre-operatively. A larger sample size will be required to draw more accurate conclusions from these findings. There is an evident need for a multicentre study examining this issue in a larger patient population in order to determine the long-term impact of different hip interventions on quality of life in children with CP

Introduction. The management of thoracolumbar burst fractures is controversial. The goal of our study was to evaluate whether the psychological factors or the late spinal deformities influence outcome and in particular quality of life following surgical treatment of burst fractures of the thoracolumbar spine. Material and methods. In a retrospective analysis, we evaluated outcome in 45 patients in whom burst fractures of the thoracolumbar spine without neurological deficits were surgically treated between April 2001 and November 2004. For this purpose, patient charts, surgery reports and x-ray images were analyzed consecutively. 29 patients could be examined physically and the outcome could be evaluated with VAS spine core, quality of life according to short-form 36 (SF36) and Beck Depression Inventory (BDI) with a minimum follow up of 30 months. Results. Mean VAS spine score was 60±26. Neither VAS spine score, nor quality of life results correlated with the following radiological findings: vertebral body angle, sagittal index and height of cranial disc space of the vertebra. Beck Depression Inventory (BDI) correlated with SF-36 score and VAS spine score (p< 0.05). Patients who were depressed showed significantly worse results in relation to the VAS spine score and the SF36 score (p< 0.01). Conclusion. For the first time, we could show, that psychological factors have high influence on functional outcome and health related quality of life in operative treated thoracolumbar burst fracture independent of x-ray findings. Therefore, we recommend inclusion of psychological components in the treatment and outcome-evaluation of the thoracolumbar burst fracture in future

Purpose. Weight loss is often advised to our patients and considered to make a substantial difference in most musculoskeletal symptoms. Patients with end stage ankle arthrosis have severe pain, diminished health related quality of life, and limited physical function. They frequently refer to increased weight as a simple indicator of decline in their quality loose weight. Patients assume that weight loss will follow after surgery secondary to increased activity with reduced pain and disability. Method. Changes in the body mass index, mental and physical component of SF36 and Ankle Scale Osteoarthritis of 145 overweight and obese patients after ankle surgery were assessed up to five year after surgery with a mean of 37.1 month follow up from 2002 to 2009. Results. The Ankle Osteoarthritis Scale and Physical component of SF36 significantly improved, by a mean of 34.8, 9.8, respectively after ankle surgery but there was not significant change in Body mass index. Conclusion. Pain and disability of end stage ankle arthritis usually resolve gradually within one and two year after surgery but body mass index changes was insignificant in five year period. In fact following successful ankle fusion or replacement, 1/3 of our patients gained 1 unit BMI or more, 1/3 lost one unit BMI or more and 1/3 remained within one unit of their pre op BMI. This suggests that obesity is a multifactorial and an independent disease

BACKGROUND:. Modern total hip arthroplasty (THA) has shown a great improvement in pain, function and range of motion of patients but data on patients' quality of life after this surgery as assessed by validated tools are lacking. METHODS:. In this cohort study we evaluated the quality of life and functionality of 250 patients an average of 16 years (11–23) after THA using the SF-36 questionnaire, the Harris Hip Score, the WOMAC score, the Functional Comorbidity Index, and a study specific questionnaire. Models of multiple stepwise linear and logistic regression analysis were constructed to evaluate the relationships between the explanatory variables and the functional outcomes. RESULTS:. The SF-36 physical indexes of these patients compared negatively with the normative values but positively with the results obtained in untreated subjects with severe hip osteoarthritis. Similar results were detected for the Harris Hip Score and WOMAC score. Patients with unilateral THA scored better than patients with bilateral THA on the RP (p < 0.001), GH (p < 0.05), SF (p < 0.05), and PCS (p < 0.05) SF-36 scales. Better results were obtained by subjects with osteonecrosis compared to those with OA on the PCS (p = 0.022) scale. There was a 96% rate of post-surgical satisfaction. A preoperative diagnosis of hip dysplasia was associated with a lesser degree of postoperative satisfaction and willingness to undergo the surgery again. Hip functionality and comorbidities were the most important determinants of physical measures on the SF-36. CONCLUSIONS:. Patients treated with THA a mean of 16 years earlier have poorer health related quality of life with respect to age-matched healthy controls. However, their scores on physical SF-36 scales still perform better in comparison with those previously reported in subjects with advanced hip osteoarthritis. The level of post-surgical satisfaction after THA is high

Background. Deciding how to allocate scarce surgical resources is a worldwide issue. These decisions are difficult when considering procedures aimed primarily at improving functional quality of life, such as lower extremity joint replacement (LEJR) surgery, and procedures perceived as life preserving which also have impacts on physical function, such as coronary artery bypass graft (CABG) surgery. Comparing functional outcomes of these two procedures may provide further evidence to guide resource allocation decisions. Methods. We compared patient-reported functional outcomes following CABG and LEJR surgery using standardised, validated outcome metrics. A retrospective review of prospectively collected pre- and post-operative health related quality of life (SF-36) measures were conducted from 105 patients undergoing elective CABG and 105 elective LEJR surgery patients. Patients were matched based on gender and age. Results. Pre-operatively, CABG patients reported statistically superior (p< 0.05) Physical Functioning, Bodily Pain, and Physical Component summary SF-36 scores compared to LEJR patients. However, their pre-operative General Health scores were lower. Surgery resulted in improvements in SF-36 scores for all patients, with statistically significant improvements in Bodily Pain and Physical Component scores occurring in both groups. Interestingly, improvements in 8 out of 10 SF-36 index scores were greater in the LEJR group, with the exception of Vitality and the Mental Component Summary. The pre-operative pattern of statistically better Physical Functioning in the CABG group, and superior General Health scores in the LEJR group remained following surgery. Conclusion. It appears that, despite being matched for age and gender, significant pre-operative general health differences exist between CABG and LEJR patients that persist post-operatively. While surgery results in significant improvements for both groups, CABG patients enjoy greater improvement in General Health scores while LEJR patients benefit from greater improvements in Bodily Pain scores. Further research is underway, examining how these differences reflect disease-specific scores and health care resource utilisation

Significance. In spite of evidence that total knee replacement (TKR) surgery is effective, numerous studies have demonstrated that approximately 20 percent of patients who have undergone TKR surgery are not satisfied. This relatively high rate of patients who are not satisfied is the result of unmet patient expectations. The strongest predictor of dissatisfaction after TKR is unmet expectations (RR = 10.7, Bourne, Chesworth, et al, 2010). This is confirmed by Dunbar, Richardson, and Robertsson (2013): “Unmet expectation seems to be a major cause of unsatisfactory outcomes and satisfaction is most strongly correlated with relief of pain, followed by improvement in physical function.” Hypothesis: One year post-operative pain relief and activity level expectations can be measured pre-operatively and used for shared decision making. Methods. A web–based system for prospectively collecting patient reported outcomes (PROs) has been developed. The data set for total hip/knee replacement surgery includes: (1) European quality of life, EQ-5D; Oxford Hip Score/Oxford Knee Score; (3) Lower Extremity Activity Scale (LEAS); and (4) Pain Likert Scale (PLS). The EQ-5D was selected as the health related quality of life (HRQL) general outcome measure because it has been adopted by multiple international joint replacement registries (Swedish Hip Arthroplasty Register, Norwegian Arthroplasty Register, United Kingdom National Joint Registry). The EQ-5D can be used to calculate quality adjusted life years (QALYs) for economic and/or comparative effectiveness analyses. The OHS/OKS questionnaires are used by the United Kingdom National Joint Registry and the New Zealand Joint Registry. The LEAS and PLS are used to measure patient's expectations for pain relief and functional improvement by asking patients to report their pre-operative pain and activity level before surgery and asking patients to report their pain and activity level expectations one year after surgery. Results. The LEAS change (one-year post-operative activity level minus pre-operative activity level) mean and standard deviation are 1.45 and 3.18. The LEAS minimum clinically important difference (MCID) is 1.59. The mean LEAS change is 0.91 MCIDs. The PLS change (one-year post-operative pain score minus pre-operative pain score) mean and standard deviation are −4.57 and 2.85. The PLS MCID is 1.43. The mean PLS change is −3.2 MCIDs. The z statistic for expected change is z = (Δ. expect. – μ. Δ. )/σ. Δ. The probability of realizing an expected activity level change greater than or equal to 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 is 68%, 56%, 43%, 31%, 21%, 13%, 7.6%, 4.0%, 2.0%, 0.9%, and 0.4%, respectively. The probability of realizing an expected pain change greater than or equal to 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 is 95%, 90%, 82%, 71%, 58%, 44%, 31%, 20%, 11%, 6.0%, and 2.8%, respectively. Conclusions. Dramatic improvement in activity level is unlikely. However, 86 percent of patients can expect clinically significant pain relief defined by pain relief greater than the MCID. Shared decision making should discuss unrealistic expectations prior to proceeding with surgery

High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding.

Cite this article: Bone Joint Res 2014;3:161–8.