Angular malalignment as cause of limitation of forearm rotation: An analysis of prospectively collected data of both-bone forearm fractures in children

Introduction

Although limitation of pronation/supination following both-bone forearm fractures in children is often attributed to an angular malunion, no clinical study has compared pronation/supination and angular malalignment of the same child by analysis of prospectively collected clinical data.

Aim

The purpose of this trial is to explore whether limitation of pronation/supination can be predicted by the degree of angular malalignment in children who sustained a both-bone forearm fracture.

Methods

In four Dutch hospitals, children aged ≤16 years with a both-bone forearm fracture were prospectively followed up consecutive children for 6–9 months. At the final follow-up, pronation/supination and angular malunion on radiographs were determined.

Results

Between January 2006 and August 2010, a total of 410 children were prospectively followed up, of which 393 children were included for analysis in this study. The mean age of the children was 8.0 (±3.5) years, of which 63% were male and 40% fractured their dominant arm. The mean time to final examination was 219 (±51) days. Children with a metaphyseal both-bone fracture of the distal forearm with an angular malalignment of ≤15° had a 9–13% chance of developing a clinically relevant limitation (i.e., <50° of pronation and/or supination), while children with an angular malalignment of ≥16° had a 60% chance. Children with diaphyseal both-bone forearm fractures with ≤5° of angular malalignment had a 13% chance of developing a clinically relevant limitation, which showed no significant increase with a further increase of angular malalignment.

Conclusions

Children who sustained a both-bone forearm fracture localised in the distal metaphysis have a higher chance of developing a clinically relevant limitation of forearm rotation in case of a more severe angular malalignment, while children with a diaphyseal both-bone forearm fracture had a moderate chance of limitation, irrespective of the severity of the angular malalignment.     

Designing Clinical Trials for Dystonia

With advances in the understanding of the pathophysiology of dystonia, novel therapeutics are being developed. Such therapies will require clinical investigation ranging from exploratory studies to examine safety, tolerability, dosage selection, and preliminary efficacy to confirmatory studies to evaluate efficacy definitively. As dystonia is a rare and complex disorder with clinical and etiological heterogeneity, clinical trials will require careful consideration of the trial design, including enrollment criteria, concomitant medication use, and outcome measures. Given the complexities of designing and implementing efficient clinical trials, it is important for clinicians and statisticians to collaborate closely throughout the clinical development process and that each has a basic understanding of both the clinical and statistical issues that must be addressed. To facilitate designing appropriate clinical trials in this field, we review important general clinical trial and regulatory principles, and discuss the critical components of trials with an emphasis on considerations specific to dystonia. Additionally, we discuss designs used in early exploratory, late exploratory, and confirmatory phases, including adaptive designs.     

Correction of thoracic kyphosis and lumbar lordosis in the treatment of idiopathic scoliosis treatment with Cotrel-Dubousset instrumentation

Background. The treatment of thoracic kyphosis and lumbar lordosis with the C-D method remains controversial. Material and methods. The lateral radiographs of 70 patients with King I, II, III, IV idiopathic scoliosis, treated with C-D instrumentation, were retrospectively analyzed. The average age was 14 +/- 1.8 years. Thoracic kyphosis between T2 and T12 and lumbar lordosis between L1 and L5 were measured. Results. Normalization of thoracic kyphosis occurred in 15 of the 22 hypokyphosis patients. The largest kyphosis correction (average +12 +/- 8 degrees ) was in the preoperative hypokyphosis group. A deep hyperkyphosis (average 64 degrees ) was found preoperatively in patients with postoperative hyperkyphosis. Kyphosis correction in the instrumented region was often reverse to the uninstrumented region correction. Lumbar lordosis remained normal in 29 (63%) and hypolordosis occurred in 14 (31%) of the 45 patients with normal preoperative lordosis. When instrumentation below L1 was performed, a greater decrease in lumbar lordosis was observed. Conclusions. The C-D method enables good kyphosis and lordosis correction in scoliotic patients, but problems may occur in greater deformities. Longer lumbar instrumentation may result in decreased lumbar lordosis.     

Usability of Ventricular Assist Devices in Daily Experience: A Multicenter Study

In daily life, the safe, intuitive use of ventricular assist devices (VADs) and especially their peripheral components is not only a question of life quality, but also sometimes crucial for survival. To investigate the advantages and disadvantages of different systems and to get patient feedback on preferred features, a multicenter study was initiated. Based on previous single‐center studies, a questionnaire was developed to ascertain patients' experiences, difficulties with, and desires concerning use of the system. This questionnaire was provided both to ongoing patients and to new VAD patients after a minimum hospital discharge time of 6 weeks, at a regular checkup. Additionally, the patients completed a standardized questionnaire on life quality (Kansas City Cardiomyopathy Questionnaire). The centers that contributed to this study were Bad Oeynhausen, Berlin, Hannover, and Vienna. Three hundred fifty‐two completed questionnaires on eight different pump types were obtained. An important result is that 42% of those questioned dropped their controller bag at least once. Depending on the device, between 2 and 55% disconnected it unintentionally. Confidence in safe use of the system decreased significantly with age, from 80% at age 20–30 years to 33% at 70–80 years. In devices with an LCD display, 94% considered the readability sufficient. Ninety‐four percent considered the training adequate. Between 22 and 88% of the patients called the emergency telephone hotline, depending on the device, and 23–46% depending on the center. This first multicenter study on VAD usability reveals considerable differences among devices and centers. The comparative assessment aims to help optimize device design, patient management, and training.     

Temsirolimus in Daily Use: Results of a Prospective Multicentre Noninterventional Study of Patients with Metastatic Kidney Cancer

Background

Temsirolimus (TEMSR) was approved for treating advanced renal cell carcinoma (RCC) in 2007. Based on the data from a single phase 3 trial, it is recommended explicitly as first-line therapy for patients with a poor clinical prognosis.

Objective

The aim of this prospective multicentre trial (STARTOR) was to examine the effectiveness of TEMSR in daily clinical practice with a broader indication in the treatment of metastatic RCC.

Design, setting, and participants

Metastatic RCC patients treated with 25 mg of TEMSR weekly were submitted to a prospective systematic evaluation and follow-up in 87 German centres between January 2008 and October 2011 using standardised procedures.

Outcome measurements and statistical analysis

All data were centrally analysed by an independent clinical research organisation.

Results and limitations

This interim analysis of the STARTOR study included 386 patients. The observed toxicity was tolerable, the median dose intensity was 91% (interquartile range: 79–100%), and the median treatment duration was 20.1 wk (95% confidence interval [CI], 17.0–23.3 wk). Clinical benefit was seen in 157 patients (40.7%); the median progression-free and overall survival were 4.9 mo (95% CI, 4.2–5.6) and 11.6 mo (95% CI, 9.3–13.9), respectively. The effectiveness of TEMSR did not differ significantly in relation to the patient's age, histologic RCC subtype, or line of treatment. The major limitations were the noninterventional study design, limited information about Memorial Sloan-Kettering Cancer Center risk factors and detailed toxicity, and the lack of central radiologic review.

Conclusions

TEMSR is an effective and largely well-tolerated treatment alternative for metastatic RCC patients in daily clinical practice, irrespective of the patient's age, histologic RCC subtype, or line of treatment.