Pull-out strength of four tibial fixation devices used in anterior cruciate ligament reconstruction.

INTRODUCTION: In reconstructions of the anterior cruciate ligament (ACL), tibial fixation can be the weak point in the assembly during the early postoperative period. The present study sought to compare pull-out strength between four tibial fixation systems used in ACL reconstruction. HYPOTHESIS: The study hypothesis was that all four devices show ≥450N pull-out strength with comparable biomechanical breakage characteristics. MATERIAL AND METHODS: An experimental study used a mechanical model to perform axial traction on a synthetic ligament (polypropylene cord folded in four) implanted in an artificial tibia (Sawbones Proximal Tibia # 1116-2: model: normal anatomy; solid foam; size: medium) using four tibial fixation systems: Ligafix® interference screw (SBM™); Bio-Intrafix® (Mitek™); Translig® (SBM™); RIGIDfix® (SBM™). For each system, four models were tested using an Instron 5566® traction machine, allowing 100mm/min stretching up to breakage. Study parameters comprised: pull-out strength, maximal whole assembly slippage, stiffness at breaking point, and type of break. RESULTS: Mean pull-out strength was 450±24N (range, 421-488N) for Ligafix®, 415±60N (327-454N) for Bio-Intrafix®, 539±66N (449-636N) for RigidFix and 1067±211N (736-1301N) for Translig®, and was significantly greater for Translig® than for the other devices (p=0.02), which did not significantly differ from one another. The expected maximal load of 450N was reached in 100% of cases with Translig® and RIGIDfix® and in 50% of cases with Bio-Intrafix® and Ligafix®. There were no significant differences regarding stiffness. Ligafix® showed significantly less slippage than the others (p=0.006), with breakage caused by the ligament sliding between bone and implant. DISCUSSION: In this in-vitro study, the Translig® fixation device showed better pull-out strength than the other three devices tested. TYPE OF STUDY AND LEVEL OF EVIDENCE: Comparative laboratory study. Level II.

First-line management of distal humerus fracture by total elbow arthroplasty in geriatric traumatology: Results in a 21-patient series at a minimum 2years' follow-up.

INTRODUCTION: Total elbow arthroplasty (TEA) is one option in distal humerus fracture in elderly osteoporotic patients. HYPOTHESIS: The study hypothesis was that, in patients aged 70years or more, TEA provides functional results and ranges of motion compatible with everyday activity, with a complications rate equal to or lower than with internal fixation, and no loss of autonomy or cognitive impairment. MATERIAL AND METHODS: In this retrospective study, 21 patients receiving TEA for distal humerus fracture were included. Mean follow-up was 3.2years, with functional (Quick DASH and MEPS), cognitive (MMSE), autonomy-related (ADL) and radiological assessment (Morrey). RESULTS: Mean MEPS was 84 and QuickDASH 32.4. Mean extension deficit was 22°, and mean flexion 125°. There was no loss of autonomy or cognitive impairment. The complications rate was 9.5%. There were no revision surgeries. DISCUSSION: TEA proved reliable in comminuted distal humerus fracture in elderly patients. Functional results were comparable to those in the literature, and the complications rate was lower. Long-term implant survival needs confirmation to validate this option as a treatment of choice in these indications in geriatric traumatology. TYPE OF STUDY: Retrospective non-comparative, single-center. LEVEL OF EVIDENCE: 4.

Development and evaluation of a Global Acne Severity Scale (GEA Scale) suitable for France and Europe.

BACKGROUND AND OBJECTIVE: Many acne grading methods exist; however, there is no agreed-upon standard. Our objective was to create and validate a reproducible acne assessment scale for rating the severity of juvenile facial acne suitable for use in France and Europe. METHODS: The scale we created described the different types of acne lesions in a manner similar to global assessment scales used in clinical trials. The scale was then validated by seven expert dermatologists in the field of acne [the Global Evaluation Acne (GEA) group] first on 34 photographic cases of Caucasian acne patients and second by clinical examination of 22 acne patients. RESULTS: There was good agreement in Investigators' assessments of acne both on photographs and patients (R = 0.8057; P < 0.0001, and R = 0.8437; P = 0.0015). CONCLUSION: The GEA Scale is a global scale validated both on photographs and acne patients which can be used either in clinical research or by the dermatologist in his office.

Inter-observer agreement on acne severity based on facial photographs.

BACKGROUND: The three-grade acne classification (mild, moderate, severe) is widely used to define the licensed indications of acne treatments, and for therapeutic decision-making in clinical practice, but its reproducibility has never been assessed. METHODS: Ten photographs of facial acne were scored independently by eight experts using the three-grade acne classification. We conducted a descriptive analysis of the results, based on graphical representation of the scores for each photograph. RESULTS: Inter-observer agreement on acne severity based on the three-grade acne classification was very poor. CONCLUSION: The classical three-grade acne classification is poorly reproducible. A new rating tool accompanied by a clinical description of each severity level would be extremely useful.

The advantage of establishing homogeneous patient groups: is it worth isolating 'juvenile acne of the face'?

BACKGROUND: Acne is a highly heterogeneous disorder with respect to its regional involvement, demographics, lesion types and response to treatment. Homogeneous patient groups must therefore be created before measuring the severity of acne and interpreting the results of therapeutic trials. The individualization of 'juvenile acne of the face' is a first step in this direction. METHODS: Based on textbooks, major reviews of acne and a 'Medline' literature search, we identified four key points to delineate sub groups of acne patients. RESULT: 'Juvenile acne of the face' is defined by four main clinical criteria: (1) age (from puberty to age 25 years), (2) site (face), (3) lesion type (polymorphous), (4) absence of a causal factor. Other subgroups of 'true' acne are listed with their distinctive characteristics. Non-acne follicular diseases (i.e. without sebum retention) are listed. DISCUSSION: We chose 'juvenile acne of the face' to define the first homogeneous group of patients because it is the most frequent form of acne and the target of most acne drugs. It has a sufficiently uniform prognosis to devise a functional and reproducible severity rating scale with the aim of facilitating the evaluation and comparison of therapeutic methods. CONCLUSION: The next step in our work will be to elaborate severity scales which are dedicated to a single type of acne.

A tool to evaluate rapidly the quality of clinical trials on topical acne treatment.

Practicing dermatologists rarely evaluate therapeutic trials. This study was designed to build a simple evaluation tool, use it to evaluate the quality of published trials and thereby consider their applicability. Reports on 146 therapeutic trials, published from 1969 to 2004, were selected. A 50-item list was used for an initial assessment. After comparison with existing grids, a shortened nine-item list was established and used for this analysis. The results were analyzed item by item (logistic regression) and globally (principal component analysis). An index was then established and validated using Cronbach's coefficient alpha. The overall quality of trials was poor: 9% to 73% positive response range. This rate increased after 1990 for six items. Two factors explained almost 60% of the total variance: factor 1 summing six items concerning the formal content of the articles and factor 2 its underlying basis. Using the sum of these six variables, Cronbach's coefficient alpha reached 0.716; their mean sum improved from 1969 to 1970-2001-2005. The significantly improved quality of trials, based on the mean sum over time, supports well-founded basis of this tool. Regarding the application of evidence-based medicine in clinical practice, this tool is user friendly and should facilitate the updating of our knowledge.

[Clinical and psychological correlation in acne: use of the ECLA and CADI scales]. / Corrélation clinique et psychologique dans l'acné: utilisation des grilles ECLA et CADI.

BACKGROUND: The psychological consequences of acne are frequently unrelated to the severity of the actual lesions. Thus, a number of scales have been designed and validated to allow quantitation of the severity of acne, such as the ECLA scale (Echelle de Cotation des Lésions d'Acné or Acne Lesion Score Scale) while others are designed to evaluate quality of life, such as the CADI (Cardiff Acne Disability Index) questionnaire recently validated in the French language. The purpose of this study was to use both of these scales in individual applications in order to determine whether or not any correlation exists between the two specific tools and to determine the two groups of patients affected by acne. METHODS: One hundred and twenty-eight acne patients (21+/-6.8 years) seen by seven dermatologists were included in this study. The severity of their acne was evaluated using the ECLA scale; the seven participating dermatologists were trained in the use of this scoring system. In addition, patients completed the CADI quality-of-life questionnaire after their consultation. Each factor on the ECLA was compared with each item in the CADI questionnaire by means of analysis of variance. RESULTS: There was no correlation between overall scores on the ECLA and CADI scales (r(2)=0.0242). However, a positive correlation was observed between overall CADI score and factors F1 and F3 in the ECLA scale (p=0.0085 and p=0.0373 respectively). In contrast, the global score on the ECLA scale was significantly correlated with item 5 of the CADI questionnaire, namely patients' perception of their acne (p=0.0035). CONCLUSION: Acne, even in mild forms, has a detrimental psychological effect on patients. The ECLA score coupled with the CADI assessment system appear to be two useful and complementary scores for use in complete acne patient management.

[Feminine acne: dermatologic disease or endocrine disease?]. / Acné féminine: maladie dermatologique ou maladie endocrinienne?

Acne is a problem of the pilo-sebaceous follicle caused by the conjunction of three factors: seborrhea, follicle obstruction, and follicle inflammation. The key element, seborrhea, is under androgenic control. Acne in women is also influenced by developments and modifications in genital life, as well as by hormonal contraceptive and replacement therapies. Acne is rare prior to puberty, when it may indicate endocrine disease. At puberty, acne is quasi-physiological, because of the relative hyperandrogenism induced by the andrenarche preceding pubarche, as well as by the relative shortage of estrogens and progesterone during the first menstrual cycles. Other signs of hyperandrogenism, such as menstrual cycle difficulties and excess weight, which favor a hormonal origin, must be sought in cases of persistent or late-onset acne in adults. There is a mirror image of puberty during the peri-menopausal period, but with decreased seborrhea, so acne is rare. Finally, a tumoral origin must be sought in the rare cases of acne occurring after menopause. Hormonal investigation of acne should not be systematic, but is justified during prepuberty when other symptoms are associated with acne that resists well-conducted dermatological treatment. The therapeutic approach should be primarily dermatological, but hormone-oriented treatment should be considered when such therapy fails, or in the presence of other signs of hyperandrogenism. Sometimes the association of isotretinoin and an anti-androgen treatment are necessary to effectively treat such acne. Finally, particular attention must be paid to contraceptive therapies and hormone treatments, which can induce or aggravate acne, especially during the peri-menopausal period.

Multicenter randomized comparative double-blind controlled clinical trial of the safety and efficacy of zinc gluconate versus minocycline hydrochloride in the treatment of inflammatory acne vulgaris.

BACKGROUND: In addition to tetracyclines, zinc may constitute an alternative treatment in inflammatory lesions of acne. OBJECTIVE: To evaluate the place of zinc gluconate in relation to antibiotics in the treatment of acne vulgaris. METHODS: Zinc was compared to minocycline in a multicenter randomized double-blind trial. 332 patients received either 30 mg elemental zinc or 100 mg minocycline over 3 months. The primary endpoint was defined as the percentage of the clinical success rate on day 90 (i.e. more than 2/3 decrease in inflammatory lesions, i.e. papules and pustules). RESULTS: This clinical success rate was 31.2% for zinc and 63.4% for minocycline. Minocycline nevertheless showed a 9% superiority in action at 1 month and one of 17% at 3 months, with respect to the mean change in lesion count. Regarding safety, the majority of the adverse effects of zinc gluconate and of minocycline concerned the gastrointestinal system and were moderate (5 dropouts with zinc gluconate and 4 with minocycline). CONCLUSION: Minocycline and zinc gluconate are both effective in the treatment of inflammatory acne, but minocycline has a superior effect evaluated to be 17% in our study.

[Acne flare-up and deterioration with oral isotretinoin]. / Poussées inflammatoires et aggravations d'acné sous isotrétinoïne orale.

BACKGROUND: Isotretinoin treatment for acne can lead to inflammatory flare-ups or an aggravation, occasionally leading to acne fulminans. The purpose of this work was to examine our cases and to propose a classification system for management. PATIENTS AND METHODS: Over a 3-year period, we selected patients referred to our dermatology unit for paradoxical aggravation of acne under isotretinoin treatment. We recorded clinical data, drug prescriptions and the course of the flare-up. RESULTS: Over 3 years (1995-1998) we observed 32 cases of acne flare-up in patients taking isotretinoin, 6 women and 26 men. DISCUSSION: Four types of aggravation could be identified depending on their date of onset, the skin signs, and the presence or not of general signs. Systemic corticosteroids are generally required, together with a lower daily dose of isotretinoin and local care (excision of open and closed comedons). Factors predictive of aggravation are young age, male sex and sebaceous retention. CONCLUSION: Acne fuminans is exceptional in patients taking isotretinoin compared with the number of patients treated. Clinicians should nevertheless be aware of the risk in order to make the diagnosis and provide appropriate care.

[Descriptive epidemiological study of acne on scholar pupils in France during autumn 1996]. / Epidémiologie descriptive de l'acné dans la population scolarisée en France métropolitaine pendant l'automne 1996.

BACKGROUND: Acne is the most common symptom prompting patients to consult a dermatologist. No previous study has been conducted in France to determine the prevalence of acne and describe the main epidemiological features. SUBJECTS AND METHODS: A cross sectional study was conducted in November 1996 and included 913 school children aged 11 to 18 years. This sample was statistically representative of the entire secondary school population in France during the 1996-1997 school year. The subjects were stratified by 5 criteria: age, sex, rural or urban residence, sun exposure, type of school. RESULTS: Taking the clinical diagnosis made by the dermatologist investigator as the main criteria, the overall prevalence of acne was 72 p. 100. It was 76.1 p. 100 using the new ECLA grading system previously described. The prevalence of acne was sex and age dependent: highest scores were found for girls aged 14-16 years and for boys aged 16-17 years. Genetic factors were very important for the outcome of acne. Finally, 41 p. 100 of the acneic subjects were following a treatment, prescribed by a dermatologist in two-third of the cases. DISCUSSION: These results are in agreement with those previously published in the literature although some differences were disclosed. It would appear important to distinguish between minimal acne with a few retentional pimples occuring during adolescence and severe acne (more than 20 pimples on the face) requiring early medical care to avoid scarring.

[ECLA grading: a system of acne classification for every day dermatological practice]. / La grille ECLA: un système de cotation de l'acné pour la pratique quotidienne du dermatologue.

BACKGROUND: Different acne gradings have been proposed: global grading, semi-global grading, quantitative grading and photographic grading. They are mainly used in clinical studies for the evaluation of acne treatment. However, it would be important for physicians to have an acne grade which would be useful for assessing acne lesions prior to treatment and following treatment efficacy. METHODS: Six French dermatologists developed an acne grading scaled called "ECLA" which only takes 2 minutes to fill out and specifically designed for use by dermatologist practitioners. In addition, the intra- and inter-observer reliability of the grading scale was assessed. RESULTS: This analysis demonstrated the excellent reliability of the ECLA grading scale both in terms of intra- and inter-observer variability except for the retentional factor. The cross physician reliability decreased with time specificity for the retention factor, indicating that previous training prior to a multicentric clinical study would be necessary. CONCLUSION: ECLA grading appears to be an interesting and useful tool in dermatology for the follow-up of acne patients.

Effect of oral isotretinoin treatment on skin androgen receptor levels in male acneic patients.

An oral daily dose (mean +/- SD, 0.75 +/- 0.05 mg/kg) of isotretinoin was administered for 3 months to six male patients with acne (scores of 4 and 5 according to Rosenfield). The therapy resulted in complete resolution of acne in four patients and improved acne significantly (score 1) in two patients. In accordance with recent findings, no change in serum testosterone and significant decreases in 5 alpha-dihydrotestosterone, 5 alpha-androstane-3 alpha,17 beta-diol glucosiduronate, and androsterone glucosiduronate levels were observed after treatment. Androgen receptor status was investigated in back skin biopsies obtained in acne areas before and after 3 months of isotretinoin treatment. The treatment did not modify the binding affinity constant of skin androgen receptor (0.44 vs. 0.32 nmol/L), but it did induce a 2.6-fold decrease in its binding capacity constant (62 vs. 24 fmol/mg cytosolic protein), as assessed by Scatchard plot and confirmed immunologically by Western blot analysis. These data clearly showed that skin androgen receptor was sensitive to oral isotretinoin administration in acneic patients. The decrease in skin androgen receptor levels (this study) and the recently reported suppression of skin 5 alpha-dihydrotestosterone production by isotretinoin treatment appeared consistent with the involvement of androgen receptor and 5 alpha-dihydrotestosterone in the pathogenesis of acne. Indeed, sebum production is under androgen control, and an abnormal response of the pilosebaceous unit to androgens appears to be implicated in the pathogenesis of acne. These observations were consistent with the absence of sebum in complete androgen-insensitive patients and normal sebum production in male pseudohermaphrodites.

Evidence for decreased androgen 5 alpha-reduction in skin and liver of men with severe acne after 13-cis-retinoic acid treatment.

To investigate the effect of 13-cis-retinoic acid (13-cis-RA) treatment on androgen metabolism in men with severe nodulocystic acne, eight men with severe acne received an oral daily dose of 0.7 mg/kg 13-cis-RA over 3 months. Exploration of androgen metabolism in serum samples, 24-h urine collections, and skin biopsies obtained before and at the end of the treatment revealed no significant alterations in serum levels of either adrenal or gonadal androgens. However, the treatment did induce significant decreases in serum levels of the 5 alpha-reduced androgens: 5 alpha-dihydrotestosterone (P < 0.02), androsterone glucosiduronate (P < 0.04), and 5 alpha-androstan-3 alpha, 17 beta-diol glucosiduronate (P < 0.004). Unlike serum, the urinary 5 alpha-reduced metabolites 5 alpha-androstan-3 alpha, 17 beta-diol and androsterone did not vary significantly despite a decrease in the excretion of the latter. Moreover, a marginally significant increase in urinary excretion of etiocholanolone, very similar to the decrease in androsterone excretion, was observed. The ratio of androsterone to etiocholanolone decreased significantly (P < 0.004) after 13-cis-RA therapy and suggested a metabolic deviation from the androgen 5 alpha- to 5 beta-reduction pathway in the liver. The most pronounced effect was observed in skin biopsies, which lost 80% of their ability to form 5 alpha-dihydrotestosterone (P < 0.001). It is concluded that 13-cis-RA therapy in men with severe nodulocystic acne did not alter gonadal or adrenal functions, but it did induce 1) a highly significant decrease in 5 alpha-dihydrotestosterone formation by skin biopsies; 2) significant decreases in serum 5 alpha-dihydrotestosterone, androsterone glucosiduronate, and 5 alpha-androstan-3 alpha, 17 beta-diol glucosiduronate; and, finally, 3) deviation of the liver androgen 5 alpha- to 5 beta-reduction pathway. The effect of 13-cis-RA treatment on severe acne is consistent with the dramatic decrease in androgen 5 alpha-reduction observed mainly in the skin.

[Acne: physiopathology and clinical aspects]. / L'acné: physiopathologie et clinique.

Acne is easy to diagnose, but its physiopathology is complex and not yet fully elucidated. However, the three factors that are necessary to the genesis of acne are well defined, being seborrhoea, obstruction of the hair follicle and the sebaceous gland, and inflammation of the follicle. To this must be added a genetic predisposition. While the skin lesions leave little doubt about the diagnosis, a thorough examination is needed to evaluate the part due to sebum retention (comedos, microcysts) and that due to inflammatory elements (papules, pustules, nodules), for the lesions are so polymorphous that it would be better to speak of acnes rather than acne. A good knowledge of clinical and physiopathological data leads to the appropriate treatment, since almost all therapeutic failures result from a misappreciation of acne.