Age and gender related differences in infection, thromboembolism, revision and death in knee arthroplasty in a Scottish population.

BACKGROUND AND AIMS: The aim of this large population based study was to investigate the effect of patient age and gender on the complication rates of knee arthroplasty surgery using data from the Scottish Arthroplasty Project joint registry. METHODS AND RESULTS: 55,636 knee arthroplasty procedures were included in the study and divided into four age categories (<55, 55-64, 65-75 and >75 years) for comparison of the 90-day deep vein thrombosis or pulmonary embolism (DVT/PE) and one-year infection rates and the mortality and revision rates up to ten-year follow up. The mean rate of DVT/PE was 1.4% with significantly higher rates in elderly patients (p = 0.0006). The mean one-year infection rate was 1.6% with a significantly increased rate of 1.9% in males (p = 0.0001). Mortality rates increased with age, the 10-year mortality in patients >75 years of age was 44.8%. Revision rates were increased in males and younger patients. CONCLUSION: Elderly patients showed higher rates of thromboembolic complications. There was no difference in infection rates between different age groups. The infection rate was higher in males. Younger patients need to be counselled about the increased risk of revision at 10 years.

Consent to discuss participation in research: a pilot study.

BACKGROUND: Equitable access to research studies needs to be increased for all patients. There is debate about which is the best approach to use to discuss participation in research in real-world clinical settings. OBJECTIVE: We aimed to determine the feasibility of asking all clinical staff within one hospital Trust (an organisation that provides secondary health services within the English and Welsh National Health Service) to use a newly created form on the Trust's electronic patient records system, as a means of asking patients to consent to discuss participation in research (the opt-in approach). We also aimed to collect feedback from patients and clinicians about their views of the opt-in approach. METHODS: Four pilot sites were selected in the Trust: two memory clinics, an adult mental health team and an acute adult ward. Data were collected in three phases: (1) for 6 months, pilot site staff were asked to complete a consent to discuss participation in research form with patients; (2) staff feedback on the form was collected through an online survey; and (3) patient feedback was collected through focus groups. FINDINGS: Of 1779 patients attending services during the pilot period, 197 (11%) had a form completed by staff and 143 (8%) opted-in to finding out about research. Staff cited limited time, low priority and poor user experience of the electronic patient records system as reasons for low uptake of the form. Patients generally approved of the approach but offered suggestions for improvement. CONCLUSIONS: There were mixed results for adopting an opt-in approach; uptake was very low, limiting its value as an effective strategy for improving access to research. CLINICAL IMPLICATIONS: Alternative strategies to the opt-in approach, such as transparent opt out approaches, warrant consideration to maximise access to research within routine clinical care.

The Role of Lateral Extra-articular Tenodesis in Primary Anterior Cruciate Ligament Reconstruction: A Systematic Review With Meta-analysis and Best-Evidence Synthesis.

BACKGROUND: The role of lateral extra-articular tenodesis (LEAT) to augment primary anterior cruciate ligament reconstruction (ACLR) remains controversial. PURPOSE: To determine whether the addition of LEAT to primary ACLR provides greater control of rotational laxity and improves clinical outcomes compared with ACLR alone and to assess the impact of early versus delayed ACLR. STUDY DESIGN: Systematic review; Level of evidence, 3. METHODS: Two reviewers independently searched 7 databases for randomized and nonrandomized clinical studies comparing ACLR plus LEAT versus ACLR alone. Animal, cadaveric, and biomechanical studies; revision or repair procedures; and studies using synthetic ligaments and multiligamentous-injured knees were excluded. Risk of bias was assessed with a modified Downs and Black checklist. The primary outcome was postoperative pivot shift. These data were pooled by use of a fixed-effects meta-analysis model. The studies were divided into delayed (>12 months) and early (≤12 months) reconstruction groups for meta-analysis. A best-evidence synthesis was performed on the remaining outcome measures. RESULTS: Of 387 titles identified, 11 articles were included (5 of high quality). Meta-analysis of postoperative pivot shift in 3 studies of delayed primary ACLR showed a statistically significant difference for the pivot-shift test in favor of ACLR with LEAT (odds ratio [OR], 0.44; 95% confidence interval [CI], 0.24-0.81; P = .008; I2 = 0). Meta-analysis of 5 studies of early primary ACLR found no statistically significant difference with the addition of LEAT (OR, 0.60; 95% CI, 0.33-1.09; P = .10; I2 = 33%). Insufficient evidence was available to determine whether the addition of LEAT had any effect on clinical, objective, subjective, and functional outcomes. CONCLUSION: In primary ACLR, no evidence is available showing additional benefit of LEAT in reducing the postoperative pivot shift in early reconstructions (≤12 months); however, LEAT may have a role in delayed ACLR. Strong evidence exists that a combined ACLR and LEAT reduces lateral femoral translation, but there is insufficient evidence to identify any benefit for other clinical outcomes.

Surgical treatments of cartilage defects of the knee: Systematic review of randomised controlled trials.

BACKGROUND: The aim of this systematic review was to identify high quality randomised controlled trials (RCTs) and to provide an update on the most appropriate surgical treatments for knee cartilage defects. METHODS: Two reviewers independently searched three databases for RCTs comparing at least two different treatment techniques for knee cartilage defects. The search strategy used terms mapped to relevant subject headings of MeSH terms. Strict inclusion and exclusion criteria were used to identify studies with patients aged between 18 and 55 years with articular cartilage defects sized between one and 15cm2. Risk of bias was performed using a Coleman Methodology Score. Data extracted included patient demographics, defect characteristics, clinical outcomes, and failure rates. RESULTS: Ten articles were included (861 patients). Eight studies compared microfracture to other treatment; four to autologous chondrocyte implantation (ACI) or matrix-induced ACI (MACI); three to osteochondral autologous transplantation (OAT); and one to BST-Cargel. Two studies reported better results with OAT than with microfracture and one reported similar results. Two studies reported superior results with cartilage regenerative techniques than with microfracture, and two reported similar results. At 10years significantly more failures occurred with microfracture compared to OAT and with OAT compared to ACI. Larger lesions (>4.5cm2) treated with cartilage regenerative techniques (ACI/MACI) had better outcomes than with microfracture. CONCLUSIONS: Based on the evidence from this systematic review no single treatment can be recommended for the treatment of knee cartilage defects. This highlights the need for further RCTs, preferably patient-blinded, using an appropriate reference treatment or a placebo procedure.

Standing balance and inter-limb balance asymmetry at one year post primary anterior cruciate ligament reconstruction: Sex differences in a cohort study of 414 patients.

BACKGROUND: Static standing balance can be safely assessed early following anterior cruciate ligament reconstruction (ACLR), and deficits may have important implications for long-term outcomes. This study includes a large cohort of people post-ACLR and has the primary aim of establishing whether inter-limb and sex differences exist, with a secondary aim of assessing the association between static balance variables and other outcome measures. METHODS: A total of 414 patients with a primary ACLR performed a 30-s static single leg balance test. Centre of pressure (COP) path length, antero-posterior (AP) and medio-lateral (ML) sway range and slow and fast speed COP path-length were examined. Additional measures included single and triple hop distance and symmetry, knee flexion range of motion, ligament laxity and the International Knee Documentation Committee (IKDC) subjective knee evaluation form. RESULTS: No significant inter-limb balance differences were present in females. Significant, yet small to negligible effect size (ES) differences were present in males for ML range (ES=0.19), and AP and ML axis slow speed path length (ES=0.11 and 0.23 respectively). Significant, negligible to moderate effect size (ES range=<0.01 to 0.60) sex differences were observed, with females showing reduced sway compared to males. No balance variables had associations with any other variable that were greater than weak. DISCUSSION: Our findings provide evidence that primary ACLR does not appear to negatively impact single leg standing balance on the operated limb more than the non-operated side. The lack of association with other outcome measures warrants further longitudinal examination into the utility of static standing balance assessment.

Improved Accuracy of Component Positioning with Robotic-Assisted Unicompartmental Knee Arthroplasty: Data from a Prospective, Randomized Controlled Study.

BACKGROUND: Higher revision rates have been reported in patients who have undergone unicompartmental knee arthroplasty compared with patients who have undergone total knee arthroplasty, with poor component positioning identified as a factor in implant failure. A robotic-assisted surgical procedure has been proposed as a method of improving the accuracy of component implantation in arthroplasty. The aim of this prospective, randomized, single-blinded, controlled trial was to evaluate the accuracy of component positioning in unicompartmental knee arthroplasty comparing robotic-assisted and conventional implantation techniques. METHODS: One hundred and thirty-nine patients were randomly assigned to treatment with either a robotic-assisted surgical procedure using the MAKO Robotic Interactive Orthopaedic Arm (RIO) system or a conventional surgical procedure using the Oxford Phase-3 unicompartmental knee replacement with traditional instrumentation. A postoperative computed tomographic scan was performed at three months to assess the accuracy of the axial, coronal, and sagittal component positioning. RESULTS: Data were available for 120 patients, sixty-two who had undergone robotic-assisted unicompartmental knee arthroplasty and fifty-eight who had undergone conventional unicompartmental knee arthroplasty. Intraobserver agreement was good for all measured component parameters. The accuracy of component positioning was improved with the use of the robotic-assisted surgical procedure, with lower root mean square errors and significantly lower median errors in all component parameters (p < 0.01). The proportion of patients with component implantation within 2° of the target position was significantly greater in the group who underwent robotic-assisted unicompartmental knee arthroplasty compared with the group who underwent conventional unicompartmental knee arthroscopy with regard to the femoral component sagittal position (57% compared with 26%, p = 0.0008), femoral component coronal position (70% compared with 28%, p = 0.0001), femoral component axial position (53% compared with 31%, p = 0.0163), tibial component sagittal position (80% compared with 22%, p = 0.0001), and tibial component axial position (48% compared with 19%, p = 0.0009). CONCLUSIONS: Robotic-assisted surgical procedures with the use of the MAKO RIO lead to improved accuracy of implant positioning compared with conventional unicompartmental knee arthroplasty surgical techniques. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Accuracy and early outcomes in medial unicompartmental knee arthroplasty performed using patient specific instrumentation.

Unicompartmental knee arthroplasty (UKA) is a technically demanding procedure and poor implant positioning has been identified as a factor in early failure. The aim of this study was to evaluate the accuracy and clinical outcomes of the patient specific instrumentation implementation technique with a fixed bearing UKA. We carried out a prospective study of 41 patients (44 procedures) between December 2011 and April 2013. The preoperative planned sizes of implants used were accurate to within one implant size change in 96% of cases. The mean post-operative limb alignment was 3.8° varus. The Oxford Knee Scores (OKS) (0-48) improved from a mean preoperative score of 23.8 to 35.6 at six weeks and 44.5 at one year. The mean improvement in OKS from preoperative to one year was 20.7. The mean one year FJS (0-100) was 80.6. At a mean follow-up of 24 months there were no complications identified and there was a 100% survivorship. This technique may offer a particular advantage to surgeons who perform lower volumes of UKA with the potential to improve both clinical outcomes and implant survivorship in UKA to achieve greater consistency of results.

A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov.

OBJECTIVES: To provide a comprehensive characterisation of rare disease clinical trials registered in ClinicalTrials.gov, and compare against characteristics of trials in non-rare diseases. DESIGN: Registry based study of ClinicalTrials.gov registration entries. METHODS: The ClinicalTrials.gov registry comprised 133,128 studies registered to September 27, 2012. By annotating medical subject heading descriptors to condition terms we could identify rare and non-rare disease trials. A total of 24,088 Interventional trials registered after January 1, 2006, conducted in the United States, Canada and/or the European Union were categorised as rare or non-rare. Characteristics of the respective trials were extracted and summarised with comparative statistics calculated where appropriate. MAIN OUTCOME MEASURES: Characteristics of interventional trials reported in the database categorised by rare and non-rare conditions to allow comparison. RESULTS: Of the 24,088 trials categorised 2,759 (11.5%) were classified as rare disease trials and 21,329 (88.5%) related to non-rare conditions. Despite the limitations of the database we found that rare disease trials differed to non-rare disease trials across all characteristics that we examined. Rare disease trials enrolled fewer participants (median 29 vs. 62), were more likely to be single arm (63.0% vs. 29.6%), non-randomised (64.5% vs. 36.1%) and open label (78.7% vs. 52.2%). A higher proportion of rare disease trials were terminated early (13.7% vs. 6.3%) and proportionally fewer rare disease studies were actively pursuing, or waiting to commence, enrolment (15.9% vs. 38.5%). CONCLUSION: Rare disease interventional trials differ from those in non-rare conditions with notable differences in enrolment, design, blinding and randomisation. However, clinical trials should aim to implement the highest trial design standards possible, regardless of whether diseases are rare or not.

Component rotational alignment in unexplained painful primary total knee arthroplasty.

BACKGROUND: Rotational malalignment of the components in total knee arthroplasty (TKA) can be a factor in poor outcomes but has yet to be defined. This study compares the rotational alignment of components in a cohort of 56 patients with unexplained pain following total knee arthroplasty with a matched control cohort of 56 patients with cemented Nex Gen Legacy posterior stabilised (LPS) flex fixed bearing TKA between March 2006 and May 2010. The aim of the study was to define an acceptable limit of rotation in total knee replacement. METHODS: Rotational alignment was calculated using the Berger protocol with post operative computerised tomography scanning. The alignment parameters measured were tibial and femoral component rotations and the combined component rotations and the component rotational mismatch. RESULTS: The two cohorts were demographically matched. Excessive internal rotation of the components was defined using the tenth percentile of rotations in the control cohort. Values of excessive internal rotation were 5.8° of the tibial component, 3.9° of the femoral component, 8.7° of combined rotation and 5.6° of the component mismatch. No significant difference was identified in excessive external rotation in any of the parameters. A significant difference in the mean rotations between the two cohorts was identified with internal rotation of the components in the painful cohort and external rotation on the control cohort. CONCLUSIONS: We identified internal rotation malalignment of the tibial (p=0.0003) and femoral (p=0.014) components individually as well as the combined component rotation (p=0.0003) and component rotation mismatch (p=0.0001) to be a factor in pain following TKA. External rotation of any of the component parameters was not identified to be a factor in painful TKA. This study adds to the understanding of rotational alignment in TKA and suggests limits of internal rotation alignment associated with painful Nex Gen Legacy posterior stabilised (LPS) flex fixed bearing TKA. LEVEL OF EVIDENCE: Level III.

Primary osseous tumors of the hindfoot: why the delay in diagnosis and should we be concerned?

BACKGROUND: Bony tumors of the foot account for approximately 3% of all osseous tumors. Diagnosis is frequently delayed as a result of lack of clinician familiarity and as a result of their rarity. The reasons for the delays, however, are unclear. QUESTIONS/PURPOSES: We therefore determined (1) how hindfoot tumors present and the specific reasons for delay in diagnosis; (2) whether the spectrum of disease varies between the talus and calcaneus; and (3) how these patients were treated. METHODS: We retrospectively reviewed the medical notes and imaging for all patients with 34 calcaneal and 23 talar tumors recorded in the Scottish Bone Tumour Registry. Demographics, presentation, investigation, histology, management, recurrence, and mortality were recorded. RESULTS: Hindfoot tumors present with pain and often swelling around the heel (calcaneus) or ankle (talus), most often misdiagnosed as soft tissue injury. Calcaneal lesions were more likely to be malignant than talar lesions: 13 of 34 versus three of 23. CONCLUSIONS: Clinicians should be aware that hindfoot tumors can be initially misdiagnosed as soft tissue injuries and suspicion of a tumor should be raised in the absence of trauma or persistent symptoms. Lesions affecting the calcaneus are more likely to be malignant. Early diagnosis and adjuvant therapy are important. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

The microgenesis of global perception in autism.

Several studies have reported that individuals with autism and Asperger's syndrome show a local processing bias on tasks involving features and configurations. This study assessed whether this bias results from differences in the perception of features or a cognitive bias to attend to features in autism as a consequence of a deficit in attending to configurations. Children with autism and typically developing children performed a task assessing the initial perceptual representation of features and configurations following a 50 ms stimulus display and the development of the perceptual representation by grouping processes following an 800 ms stimulus display. No differences were observed between the two groups, suggesting that the perceptual and attentional mechanisms marshalled by this task operate typically in children with autism.

Technical results and effects of operator experience on uterine artery embolization for fibroids: the Ontario Uterine Fibroid Embolization Trial.

PURPOSE: To document the technical results and spectrum of practice of uterine artery embolization (UAE) for fibroids in the health care setting in Canada. The effects of interventional radiologist's (IR's) experience with UAE on procedure and fluoroscopy time were also investigated. MATERIALS AND METHODS: The study involved a multicenter prospective single-arm clinical treatment trial and included the practices of 11 IRs at eight university-affiliated teaching and community hospitals. Vascular access with percutaneous femoral artery approach was followed by transcatheter delivery of polyvinyl alcohol (PVA) particles into uterine arteries with fluoroscopic guidance. Technical success, complications, procedural time, fluoroscopy time, and effects of operator experience were outcomes analyzed. RESULTS: Between November 1998 and November 2000, 570 embolization procedures were performed in 555 patients. UAE was bilaterally successful in 97% (95% CI: 95%-98%). Variant anatomy was the most common reason for failure to embolize bilaterally. The procedural complication rate was 5.3% (95% CI: 3.6%-7.4%). Of the 30 events, three involved major complications (one seizure and two allergic reactions) that resulted in additional care or extended hospital stay. Procedure time and fluoroscopy time averaged 61 minutes (95% CI; 58-63 minutes) and 18.9 minutes (95% CI; 18-19.8) and varied significantly among IRs (P <.001; P <.001). The average 27% reduction in procedure time (20 minutes; P <.001) and 24% reduction in fluoroscopy time (5.1 minutes; P <.001) with increasing UAE experience were significant. CONCLUSIONS: A high level of technical success with few complications was obtained with a variety of operators in diverse practice settings. Increased experience in UAE significantly reduced procedure and fluoroscopy time.

The Ontario Uterine Fibroid Embolization Trial. Part 1. Baseline patient characteristics, fibroid burden, and impact on life.

OBJECTIVE: To determine baseline characteristics of women undergoing uterine artery embolization (UAE) for symptomatic fibroids. DESIGN: Multicenter, prospective, single-arm clinical treatment trial. SETTING: Eight Ontario university and community hospitals. PATIENT(S): Five hundred fifty-five women undergoing UAE for fibroids. INTERVENTION(S): Baseline questionnaires completed before UAE. MAIN OUTCOME MEASURE(S): Questionnaires were analyzed for demographic, medical, and gynecologic histories. Fibroid symptoms, impact of symptoms, previous consultations, and treatments were also analyzed. RESULT(S): The Ontario cohort (66% white, 23% black, 11% other races) had an average age of 43. Thirty-one percent were under age 40. Most women were university educated (68%) and working outside the home (85%). Women reported heavy menstrual bleeding (80%), urinary urgency/frequency (73%), pain during intercourse (41%), and work absences (40%). They experienced fibroid-related symptoms for an average of 5 years and consulted with on average of three gynecologists before UAE. High fibroid life-impact scores were reported by 58%. Black women were significantly younger (40.7 vs. 44.0 years), more likely to experience symptoms longer (7 vs. 5 years), and more likely to undergo myomectomy before UAE (24% vs. 9%) than white women. CONCLUSION(S): Our study illustrates that large numbers of women with highly symptomatic fibroid disease are averse to surgery despite their burden of suffering and are actively seeking alternatives to hysterectomy.