Acute quadriceps tendon rupture repaired by suture anchors: Outcomes at 7 years' follow-up in 25 cases.

INTRODUCTION: Acute quadriceps tendon rupture is rare. The gold-standard repair technique is transosseous patellar suture. Biomechanical studies have validated the use of anchors as an alternative. The present study sought to report long-term clinical and radiological results in a series of acute quadriceps tendon rupture repaired with anchors. The study hypothesis was that results are comparable to those of the gold-standard technique. METHODS: A retrospective continuous study included 25 knees with acute quadriceps tendon rupture, operated on by a single surgeon between 2007 and 2013: 22 patients; 17 males, 5 females; mean age, 64 years (range: 52-87 years). Modified Bunnell suture was performed, using either 2 anchors (19 knees) or 3 anchors (6 knees). Anchors were positioned under 20° flexion. The factors studied were: active range of motion, muscle strength, patient satisfaction, Lysholm score, return to work, and the radiological behavior of the anchors. RESULTS: At a mean follow-up of 7 years (range: 3-9 years), all but 1 patient had 0° active extension. Mean active flexion was 128° (range: 110-150°), and mean muscle strength was 4.9/5. Mean Lysholm score was 92. Subjective results proved satisfactory or very satisfactory in 23 cases. Working patients returned to work at a mean 4.2 months. There were no cases of anchor migration or of re-rupture. One poorly tolerated anchor was ablated at 2 years, without functional impact. CONCLUSION: Outcomes with anchors were comparable to those of the gold-standard technique. Anchors allow immediate rehabilitation, without risk of anchor migration. The technique provided satisfactory functional recovery. LEVEL OF EVIDENCE: IV, retrospective cohort study.

Validation of an emergency triage scale for obstetrics and gynaecology: a prospective study.

OBJECTIVE: To evaluate the reliability of a four-level triage scale for obstetrics and gynaecology emergencies and to explore the factors associated with an optimal triage. DESIGN: Thirty clinical vignettes presenting the most frequent indications for obstetrics and gynaecology emergency consultations were evaluated twice using a computerised simulator. SETTING: The study was performed at the emergency unit of obstetrics and gynaecology at the Geneva University Hospitals. SAMPLE: The vignettes were submitted to nurses and midwives. METHODS: We assessed inter- and intra-rater reliability and agreement using a two-way mixed-effects intra-class correlation (ICC). We also performed a generalised linear mixed model to evaluate factors associated triage correctness. MAIN OUTCOME MEASURES: Triage acuity. RESULTS: We obtained a total of 1191 evaluations. Inter-rater reliability was good (ICC 0.748; 95% CI 0.633-0.858) and intra-rater reliability was almost perfect (ICC 0.812; 95% CI 0.726-0.889). We observed a wide variability: the mean number of questions varied from 6.9 to 18.9 across individuals and from 8.4 to 16.9 across vignettes. Triage acuity was underestimated in 12.4% of cases and overestimated in 9.3%. Undertriage occurred less frequently for gynaecology compared with obstetric vignettes [odds ratio (OR) 0.45; 95% CI 0.23-0.91; P = 0.035] and decreased with the number of questions asked (OR 0.94; 95% CI 0.88-0.99; P = 0.047). Certification in obstetrics and gynaecology emergencies was an independent factor for the avoidance of undertriage (OR 0.35; 95% CI 0.17-0.70; P = 0.003). CONCLUSION: The four-level triage scale is a valid and reliable tool for the integrated emergency management of obstetrics and gynaecology patients. TWEETABLE ABSTRACT: The Swiss Emergency Triage Scale is a valid and reliable tool for obstetrics and gynaecology emergency triage.

Clinical pharmacology of ponesimod, a selective S1P1 receptor modulator, after uptitration to supratherapeutic doses in healthy subjects.

PURPOSE: The aim of this study was to assess in healthy subjects the safety, tolerability, pharmacokinetics, and pharmacodynamics of ponesimod, an oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator in development for multiple sclerosis, by using an uptitration scheme up to supratherapeutic doses. METHODS: This was a double-blind, placebo-controlled, randomised, parallel group, uptitration study. Male and female subjects received ascending oral doses of ponesimod (n=12) or placebo (n=4) once daily for 3 days at each dose level (10-20-40-60-80-100mg). RESULTS: The most frequent adverse events were chest discomfort, headache, dizziness, dyspnoea, abdominal pain, and night sweats. Chest discomfort and dyspnoea were considered dose-limiting. A transient decrease in heart rate was observed following the first 10-mg ponesimod dose (maximum mean decrease of 9 beats per minute (bpm) (placebo: 2 bpm)). After uptitration, effects on heart rate were indistinguishable from placebo. A dose-dependent effect on pulmonary function tests was observed and reached a plateau with 60-80 mg ponesimod (maximum mean decrease from baseline of 1.24l (-30.5%) in forced expiratory volume in 1s). A plateau in mean lymphocyte count reduction of approximately 70% from baseline was reached at the 40 mg dose level. Observed effects were fully reversible within 10days after treatment discontinuation. No relevant sex differences were observed. CONCLUSIONS: At supratherapeutic doses, symptoms of chest discomfort and dyspnoea were dose-limiting. An uptitration dosing scheme is to be preferred in clinical studies in patients in order to limit effects of ponesimod on heart rate and atrioventricular (AV) conduction.

Multiple-dose tolerability, pharmacokinetics, and pharmacodynamics of ponesimod, an S1P1 receptor modulator: favorable impact of dose up-titration.

This multiple-ascending-dose study investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of ponesimod, an S1P1 receptor modulator and a potential new treatment for autoimmune diseases. In part A, 10 healthy male and female subjects received once daily oral doses of ponesimod (5, 10, or 20 mg) or placebo for 7 days. Sinus bradycardia and, in some subjects, atrioventricular (AV) block occurred primarily on the first day of dosing, as desensitization developed to ponesimod-induced heart rate (HR) reduction and PR-prolongation. This elicited the design of an up-titration schedule in 17 subjects to a dose of 40 mg in part B. The up-titration regimen reduced HR and PQ/PR effects. Reported adverse events were mainly related to the cardiac and respiratory systems. Respiratory effects increased with higher doses. Ponesimod multiple-dose pharmacokinetics were slightly more than dose-proportional and characterized by a time to maximum concentration and an elimination half-life varying from 2.5 to 4.0 hours and 30.9 to 33.5 hours, respectively, and an accumulation of about 2.3-fold. Ponesimod caused a dose-dependent sustained decrease in total lymphocyte count, reversible within 7 days of discontinuation. A pharmacokinetic-pharmacodynamic model enabled comparing day 1 and steady-state conditions. These results warrant further investigation of ponesimod in patients.