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

The patient's subjective experience of disease is an increasing focus in health care delivery. Health-related quality of life (HRQoL) is defined as a “functional effect of a medical condition and its consequent treatment”; it is both self-reported and multi-dimensional. While functional outcome is well researched among the soft tissue sarcoma (STS) population, few studies have focused on HRQoL, which gives a broader understanding of the psychological, somatic, social and physical toll of cancer and its treatment from the patient's viewpoint. The biologic and anatomic heterogeneity of sarcomas are considerable, just as the treatments are diverse, we surmise that the indicators of patient HRQoL differ and are not captured in existing generic HRQoL tools for cancer. The study objectives were to explore the domains of HRQoL and functioning in adult patients diagnosed with extremity STS from the patient's perspective from active care through survivorship through qualitative inquiry, so as to form the basis for the development of a patient-derived, sarcoma-specific, preference based HRQoL tool. Study design is a sequential exploratory mixed methods study of patient experience in localized or metastatic adult extremity STS (2007 and 2017). The study was conducted at a high-volume sarcoma centre. Qualitative descriptive design was grounded in an integrated knowledge translation approach and aimed at identifying HRQoL domains through in-person and electronic focus groups, and individual semi-structured interviews in both English and French (N=28). The interview guide topics were selected based on existing knowledge about PROs and HRQoL life, including (a) impact of diagnosis on employment or acquisition of academic/vocational skills; (b) physical and psychological functioning; (c) symptom burden; (d) treatment preferences; (e) knowledge of and use of existing resources; (f) impact on family time and resources; and (g) overall experience. Data was analyzed using inductive thematic networks approach using the qualitative software N-Vivo 12. Codes were generated by 2 independent qualitative experts capturing key concepts of HRQoL that is impacted by STS. Basic themes were clustered into organizing themes, and merged into global domains. Attention was paid to deviant cases and within-group dynamics during focus group discussion analysis. Discrepancies or inconsistencies in coding were resolved in consensus meetings. Final sample size was determined when data saturation was reached and no new themes emerged. Qualitative reduction of identified items to reach a consensus framework was facilitated by a moderator during multi-disciplinary panel meetings comprised of sarcoma experts, patient partners, allied health staff and other stakeholders. Twenty-nine patients with biopsy-proven localized or metastatic STS of the extremity participated (69% lower extremity STS; mean age 56 years, 25% with local recurrence, 21% metastatic, 18% amputation). Inductive thematic network analysis revealed five function-related domains HRQoL for patients with STS. The functional domains were mapped to the Wilson & Cleary Model and experience domains were mapped to the Picker Institute's Through Patient's Eyes model. This is a critical step toward developing disease specific outcome measures. Patient-centered research is crucial to understanding the impact of surgery, adjuvant therapy and the associated complications for patients with extremity STS, and thereby improving the quality of care provision. This study offers a unique perspective on what domains and sub domains are most impactful on HRQoL and provides the basis for our on-going development of a disease-specific, preference-based HRQoL measure

Aims. It is well described that patients with bone and joint infections (BJIs) commonly experience significant functional impairment and disability. Published literature is lacking on the impact of BJIs on mental health. Therefore, the aim of this study was to assess health-related quality of life (HRQoL) and the impact on mental health in patients with BJIs. Methods. The AO Trauma Infection Registry is a prospective multinational registry. In total, 229 adult patients with long-bone BJI were enrolled between 1 November 2012 and 31 August 2017 in 18 centres from ten countries. Clinical outcome data, demographic data, and details on infections and treatments were collected. Patient-reported outcomes using the 36-Item Short-Form Health Survey questionnaire (SF-36), Parker Mobility Score, and Katz Index of Independence in Activities of Daily Living were assessed at one, six, and 12 months. The SF-36 mental component subscales were analyzed and correlated with infection characteristics and clinical outcome. Results. The SF-36 physical component summary mean at baseline was 30.9 (95% CI 29.7 to 32.0). At one month, it was unchanged (30.5; 95% CI 29.5 to 31.5; p = 0.447); it had improved statistically significantly at six months (35.5; 95% CI 34.2 to 36.7; p < 0.001) and at 12 months (37.9; 95% CI 36.4 to 39.3; p < 0.001). The SF-36 mental component summary mean at baseline was 42.5 (95% CI 40.8 to 44.2). At one month, it was unchanged (43.1; 95% CI 41.4 to 44.8; p = 0.458); it had improved statistically significantly at six months (47.1; 95% CI 45.4 to 48.7; p < 0.001) and at 12 months (46.7; 95% CI 45.0 to 48.5; p < 0.001). All mental subscales had improved by the end of the study, but mental health status remained compromised in comparison with the average USA population. Conclusion. BJIs considerably impact HRQoL, particularly mental health. Patients suffering from BJIs reported considerable limitations in their daily and social activities due to psychological problems. Impaired mental health may be explained by the chronic nature of BJIs, and therefore the mental wellbeing of these patients should be monitored closely. Cite this article: Bone Jt Open 2024;5(9):721–728

Proximal junctional kyphosis (PJK) is defined as adjacent segment kyphosis >10° between the upper instrumented vertebrae and the vertebrae 2 levels above following scoliosis surgery. There are few studies investigating the predictors and clinical sequelae involved with this relatively common complication. Our purpose was to determine the radiographic predictors of post-op PJK and to examine the association between PJK and pain/HRQOL following surgery for AIS. The Post-Operative Recovery after Scoliosis Correction: Home Experience (PORSCHE) study was a prospective multicenter cohort of AIS patients undergoing spinal fusion surgery. Pre-op and minimum 2 year f/u scoliosis and sagittal spinopelvic parameters (thoracic kyphosis–TK, lordosis–LL, pelvic tilt-PT, sacral slope-SS, pelvic incidence-PI) were measured and compared to numeric rating scale for pain (NRS) score, SRS-30 HRQOL and to the presence or absence of PJK (proximal junctional angle >100). Continuous and categorical variables were assessed using logistic regression and binomial variables were compared to binomial outcomes using chi-square. 163 (137 females) patients from 8 Canadian centers met inclusion criteria. At final f/u, PJK was present in 27 patients (17%). Pre-op means for PJK vs No PJK: Age 14.1 vs 14.7yr; females 85 vs 86%; scoliosis 57±22 vs 62±15deg; TK 28±18 vs 19±16deg ∗, LL 62±11 vs 60±12deg, PT 8±12 vs 10±10deg, SS 39±8 vs 41±9deg, PI 47±14 vs 52±13deg, SVA −9±30 vs −7±31mm. Final f/u for PJK vs No PJK: Scoliosis 20±11 vs 18±8deg, final TK 26±12 vs 19±10deg∗, LL 60±11 vs 57±12deg, PT 9±12 vs 12±13deg, SS 39±9 vs 41±9deg, PI 48±17 vs 52±14deg, SVA −23±26 vs −9±32mm∗. Significant findings: Pre-op kyphosis >40deg has an odds ratio (OR) of 4.41 (1.50–12.92) for developing PJK∗. The presence of PJK was not associated with any significant differences in NRS or SRS-30. ∗denotes p<0.05. This prospective multicenter cohort of AIS patients demonstrated a 17% risk of developing PJK. Pre-op thoracic kyphosis >40deg was associated with the development of PJK; however, the presence of PJK was not associated with increased pain or decreased HRQOL

The burden of metastatic bone disease (MBD) in our Canadian cancer population continues to increase. MBD has a significant effect on patient morbidity, mortality, and health-related quality of life (HRQOL). There are various technical options used to surgically stabilize MBD lesions, surgical decision-making is variable and largely dependent on anatomic and surgeon-based factors. There is a paucity of research examining how surgical decision-making for MBD can be modified or individualized to improve quality of life (QOL) and functional outcomes, while more accurately aligning with patient-reported goals and expectations. The objective of this study was tosurvey MBD patients, support persons, physicians, and allied health care providers (HCP) with the goal of identifying 1) important contributors to HRQOL, 2) discordance in peri-operative expectations, and 3) perceived measures of success in the surgical management of MBD. This project is a longitudinal patient-engaged research initiative in MBD. A survey was developed based on HRQOL themes in the literature and based on feedback from our patient research partners. Participants were asked to identify 1) important contributors to HRQOL and 2) perceived measures of success relevant to the surgical management of MBD. Participants were asked to rank themes from ‘extremely important’ to ‘not important at all’. Using open-ended questions, participants were asked to identify areas of improvement. Responses from the open-ended questions were analyzed by an experienced qualitative researcher using conventional content analysis. Participant's demographics were calculated using descriptive statistics. Concordance or discordance of perceived measure of success was assessed via a Chi-Square test of independence. All statistical analyses were performed using IBM SPSS® software. Nine patients, seven support persons, 23 orthopaedic surgeons, 11 medical oncologists, 16 radiation oncologists, 16 nurses, and eight physiotherapists completed the survey. Regarding perceived measures of success, increased life expectancy (p Two main themes emerged around the timeliness of surgical care and the coordination of multidisciplinary care from patients and support persons. Patients and support persons expressed a sense of urgency in progressing to surgery/treatment, and frustration at perceived delays in treatment. Within coordination of care, patients and support persons would like clearer communication from the health care team. There is discordance between patient/support person goals compared to physicians/HCP goals in the surgical management of MBD. Surgical decision-making and operative techniques that minimize disease progression and improve survival are important to MBD patients. Timely access to surgery/surgical consultation and improved multidisciplinary communication is important to patients. This data suggests improved peri-operative communication and education is needed for MBD patients. Furthermore, future research evaluating how modern orthopaedic surgical techniques influence survival and disease progression in MBD is highly relevant and important to patients with MBD

The ability to calculate quality-adjusted life-years (QALYs) for degenerative cervical myelopathy (DCM) would enhance treatment decision making and facilitate economic analysis. QALYs are calculated using utilities, or health-related quality-of-life (HRQoL) weights. An instrument designed for cervical myelopathy disease would increase the sensitivity and specificity of HRQoL assessments. The objective of this study is to develop a multi-attribute utility function for the modified Japanese Orthopedic Association (mJOA) Score. We recruited a sample of 760 adults from a market research panel. Using an online discrete choice experiment (DCE), participants rated 8 choice sets based on mJOA health states. A multi-attribute utility function was estimated using a mixed multinomial-logit regression model (MIXL). The sample was partitioned into a training set used for model fitting and validation set used for model evaluation. The regression model demonstrated good predictive performance on the validation set with an AUC of 0.81 (95% CI: 0.80-0.82)). The regression model was used to develop a utility scoring rubric for the mJOA. Regression results revealed that participants did not regard all mJOA domains as equally important. The rank order of importance was (in decreasing order): lower extremity motor function, upper extremity motor function, sphincter function, upper extremity sensation. This study provides a simple technique for converting the mJOA score to utilities and quantify the importance of mJOA domains. The ability to evaluate QALYs for DCM will facilitate economic analysis and patient counseling. Clinicians should use these findings in order to offer treatments that maximize function in the attributes viewed most important by patients

Adolescent idiopathic scoliosis is a three-dimensional deformity of the spine, affecting 1–3% of the population. Most cases are treated conservatively. Curves exceeding 45° in the thoracic spine and 40° in the lumbar spine may require correction and fusion surgery, to limit the progression of the curve and prevent restrictive pulmonary insufficiency (curves above 70°). When fusion is required, it may be performed either by posterior or anterior approaches. Posterior is useful for thoracic (Lenke I) curves, notably to correct the thoracic hypokyphosis frequently observed in AIS. Anterior approaches by thoraco-lombotomies allow an effective correction of thoraco-lumbar and lumbar curves (Lenke V and VI), with fewer levels fused than with posterior approaches. However, the approach requires diaphragm splitting and one may be concerned about the long-term pulmonary consequences. The literature provides conflicting insight regarding the consequences of the approach in anterior scoliosis correction, the interpretation of the results being difficult knowing that the correction of the scoliosis itself may improve pulmonary function. This is a retrospective observational study done at a Tertiary Institution. The HRQOL scores have been collected as a prospective cohort. Clinical and radiographic data was collected from patients charts and analysed by two senior surgeons. A cohort of 64 patients were operated in the given time period. 50 patients met the inclusion criteria. No major complications were reported. The Union rate was 100% and no post operative complications were noted. Pre and post SRS scores improved in all patients. The Anterior approach for Lenke V AIS gives great surgical exposure and allows for excellent correction of Cobb angle with minimal risk to the patient

Aim. Very limited information is available regarding health-related quality of life (HRQOL) and patient reported hip function following treatment for chronic periprosthetic hip joint infection (PJI). Several reviews have not found any clear differences in clinical outcome parameters comparing the most commonly applied treatment strategies for chronic hip PJI. Studies describing patients HRQOL of one-stage and two-stage revision could provide important information regarding patient counselling. The purpose of this study was to investigate HRQOL and patient reported hip function after one-stage revision and two-stage revision in chronic hip PJI. Method. The one-stage group was identified in a prospective clinical study on one-stage revision in chronic hip PJI. Fifty-one patients were followed for two years on an outpatient basis and completed three questionnaires; EuroQol-5D (EQ-5D), Short Form Health Survey 36 (SF-36) and Oxford Hip Score (OHS) at 3, 6, 12 and 24 months follow-up. The two-stage group was identified retrospectively in the National Patient Register and 45 patients completed EQ-5D and OHS. The observed results were compared to normative population data for SF-36 and EQ-5D. Results. In the one-stage group the improvement in HRQOL appeared in the first 6 months after surgery, reached a plateau, and decreased slightly again. The largest improvements at 2 years were OHS with an effect size (ES): 1.3 and SF-36's physical role limitation and bodily pain with ES: 1.1. The one-stage group reached the matched population norm on all parameters at 12 months, but two scores declined from 12 to 24 months: physical functioning (66 to 50 (out of 100, population norm 71) and physical role limitation (58 to 40, population norm 63). Neither the one-stage nor the two-stage group reached the EQ-5D population norm. When comparing the two groups, the mean scores (CI 95%) for one-stage revision were significantly higher compared to the two-stage revision group on EQ-5D. VAS. 12.9 (2.4;23.3 p=0.02) and OHS 5.9 (0.5;11.2 p=0.03), but not on EQ-5D. index. 0.065 (−0.04;0.17 p= 0.22). Conclusions. Two years after receiving one-stage revision the patients experienced a significant increase in HRQOL and reported hip function, and matched the population norm on most parameters. The decrease in physical scores at 24 months could be attributed to co-morbidities. Neither group reached the EQ-5D population norm. Patients receiving one-stage revision obtained higher HRQOL and hip function compared to two-stage revision. However, a direct comparison of the two groups cannot be performed due to difference in study design

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

Instrumented fusion for lumbar degenerative spondylolisthesis (LDS) has been challenged recently with high impact trials demonstrating similar changes in health-related quality of life (HRQOL) and less morbidity/cost with laminectomy alone. Randomized trials often fail, however, to evaluate a heterogeneous population of patients. A standardized clinical assessment and management plan (SCAMP) was created as a decision aid for surgeons based on the radiographic stability and clinical presentation of patients. The purpose of this study was to compare outcomes of those patients who followed the decision aid with respect to fusion/no fusion to those who did not. Patients were prospectively enrolled from eleven different Canadian institutions and followed from 2015–2019. A degenerative spondylolisthesis instability classification system (DSIC) was created using best available evidence stratifying patients into three different subtypes (1. stable degenerative spondylolisthesis, 2. potentially unstable spondylolisthesis and 3. unstable spondylolisthesis). The decision aid recommends laminectomy alone for group 1 patients, posterolateral fusion with pedicle screws in type 2 patients and pedicle screw and interbody fusion for type 3 patients. One year changes in HRQOL, length of hospital stay (LOS), medication use and surgical time were compared between each group and in context of whether the treatment fell within the decision aid recommendation. Statistics were performed with STATA software. There were 394 patients initially enrolled and 334 (84.8%) with full one year data available for comparison. There were 95 type 1 (stable), 224 type 2 (potentially unstable) and 75 type 3 (unstable) patients initially classified. Baseline Ostwestry disability index (ODI), EQ-5D, and SF-12 MCS scores were significantly worse for type 3 patients versus type 1 patients. One hundred and eight patients were treated within the recommendations of the DSIC system (108/334, 32.3%). Surgeons performed interbody fusions in 141 patients (42%) rather than follow DSIC recommending a less invasive approach. There were no significant differences EQ-5D, SF-12 PCS/MCS, PHQ-9 or ODI at one year between patient groups. There was a trend towards shorter operating times for those patients following the DSIC system (195 minutes non-followers versus 180 followers, p=0.078) and reduced hospital stay (4.46 days non-followers versus 3.98 followers, p=0.065). There were no significant clinical differences in outcome at 1 year whether patients underwent decompression alone, decompression/posterolateral fusion or interbody fusion regardless of the stability classification. Surgeons were more likely to perform potentially unnecessary interbody fusions even in those patients with stable or potentially unstable spondylolisthesis. Although not statistically significant, there is some suggestion that following the DSIC system based on best evidence recommendations leads to more judicious/responsible use of hospital resources. Further study is required to determine why surgeons are more likely to choose more invasive, higher rigidity constructs in patients with LDS

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. Published literature that examined pre-operative Body Mass Index (BMI) with Total Knee Arthroplasty (TKA) outcomes have shown conflicting data. Some show that higher BMI and is associated with poorer post-TKA function and HRQoL outcomes, but not others. The aim of our analyses is to identify the relationship of pre-operative obesity with the outcomes of TKA, including physical and mental functional limitations. Methods. We performed a prospective analysis of a consecutive series of 191 patients, who had underwent TKA from March 2006 to February 2011, performed by a single surgeon, at Singapore General Hospital, Singapore. Patients were eligible if they had met the following criteria: primary, unilateral TKA, using fixed bearing, posterior stabilized prostheses, under computer assisted surgery system. Patients were reviewed clinically at 6 months and 2 years post-operatively. Patients were stratified into non-obese (BMI <30 kg/m2), mildly obese (BMI 30 to 35) and highly obese (BMI ≥35) groups. Outcome measures evaluated include: SF-36, Oxford knee score and Knee Society Score. Results. 44 patients (23%) were obese, further stratified into 35 (18%) mildly obese patients, and 9 (5%) highly obese patients. Obese and mildly obese patients had poorer knee flexion degrees when compared to non-obese patients, although knee extension degrees were similar. Knee ranges of motion were poorer in obese and mildly obese patients than in non-obese patients. Knee Society Scores. KSS function and knee outcome scores were significantly better in all patient groups, at 2 years post TKA compared to pre-operatively. At 6 months, all KSS function and knee scores were also better in all subgroups than pre-operative scores, with the exception of the highly obese group which did not show a significant difference. Obese and mildly obese patients had worse knee scores compared to non-obese patients pre-operatively, but similar scores post-operatively at 6 months and 2 years. Function scores for highly obese compared to non obese patients were significantly worse at the 6 month assessment, although not at the pre-operative and 2 years post-operative assessments. Oxford knee scores. OKS scores were significantly better in all patient groups, at 6 months and 2 years post TKA compared to pre-operative scores. Pre-operative OKS scores are worse in obese compared to non-obese patients, but similar at 6 months and 2 years. Highly obese patients had worse OKS scores pre-operatively, and at 6 months, but not at 2 years. SF-36 scores. SF-36 physical and mental scores were better in obese and mildly obese patients compared to non-obese patients, at 6 months and 2 years post-operatively. Highly obese patients had worse physical and mental scores at 2 years. Obese patients had poorer physical scores pre-operatively and at 6 months, but not at 2 years. Highly obese patients had poorer physical scores only at 6 months post-operatively. Highly obese patients had poorer mental scores pre-operatively compared to non-obese patients. Conclusion. Obese patients in our study who had poorer functional scores pre-operatively also had generally poorer functional scores 6 months post TKA. However, this difference was not observed at 2 years post TKA

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.