Prospective mid-term results of a consecutive series of a short stem.

A large number of short stem prostheses for hip -arthroplasty have been introduced in the past years. Although there is a large increase of publications about short stems, there is still little data available about survival and revision rates. We report prospectively on the outcome of 84 consecutive NANOS® short stem prostheses in 81 patients. We have included 37 female patients and 44 male patients with an average age of 61.6 ±â€ˆ9.2 years. The main diagnoses were osteoarthritis in 67 patients, dysplastic osteoarthritis in 8 patients and avascular necrosis of the femoral head in 6 patients. Along with demographic data and co-morbidities, the Harris Hip Score was recorded preoperatively and at follow-up. The Harris Hip Score increased from 36.6 ±â€ˆ14.5 preoperatively to 94.5 ±â€ˆ8.8 at the final follow-up. During the main follow-up time (27.7 months ±â€ˆ5.7) none of the 84 stems were revised, intraoperatively three fissure fractures occurred.

[Clinical trials in oncology: specific methodology problems]. / Essais cliniques en cancérologie: problèmes méthodologiques spécifiques.

Clinical benefit in oncology patients can only be derived from coordinated and successive experimental trials. The following consensus thus emerged from the working party: The assessment of tolerance during clinical trials requires the actuarial rate of acute adverse events (AE) to be registered and the development of epidemiological structures involved in long-term assessment of AE. Experimental trials have to be assessed according to descriptive epidemiological data (generated in France and Europe) and completed with observational studies on post-marketing medical practice. The principle of an a priori authorization given by the Afssaps for gene and cell therapy trials was legalised in October 2001. The working group spoke strongly in favour of authorizing early trials only validating the process, and for reasonable objectives in terms of viral security assessment of annex therapeutic products. With regard to the development of new antiproliferative agents, the active dose (or optimal biological dose) replaces the maximal tolerable dose. Early efficacy criteria could be biological and specific. With cumulative subacute rather than acute toxicity, these agents can not be properly evaluated with a short term benefit/risk ratio as is done for cytotoxic drugs. Elderly people constitute a fragile, heterogeneous and increasing population, in whom adequate assessment of anticancer agents is mandatory. It is important to promote controlled clinical trials in children and to systematically monitor them over a very long period of time. Only rare tumours may be considered as orphan situations. Finally, a list of all clinical trials conducted in oncology should be made by the Afssaps, with the help of the FNLCC (Fédération Nationale des Centres de Lutte Contre le Cancer) who have already begun this work.

[Communication and transparency concerning risk-benefit analysis in public health: the example of medication]. / Communication et transparence de l'évaluation du risque et bénéfice en santé publique: exemple du médicament.

As far as communication of the evaluation of risk benefit assessment of medications is concerned, validated and interpreted data only have to be taken into account. Free access to information by the public has to be considered seriously and there is now a real and strong demand. This situation has to be viewed in parallel with the huge development of websites communicating information on health issues. This report summarizes the discussion between the authorities and pharmaceutical companies and reports the different concrete proposals that emerged.

[Health foods: definitions, status, public health. Round table no. 4. XV]. / Alicaments: définitions, statuts, apports en Santé Publique. Table Ronde no 4 de Giens. XV.

'Alicaments' ('ali' for 'aliment' = 'food' in French, and 'cament' for medicament = drug), is an inappropriate term to designate a developing domain: functional foods, in other words health claims in nutrition. It is not easy to delineate the frontier between foods and drugs; this results in some regulatory problems. The key question is the evaluation of health claims. In this report, we synthesize the discussions of a workshop bringing together specialists from the food industry and nutritionists, scientists and representatives of public health departments.

Noninvasive whole-body electrical bioimpedance cardiac output and invasive thermodilution cardiac output in high-risk surgical patients.

OBJECTIVE: To evaluate the reliability of whole-body impedance cardiography with two electrodes on either both wrists or one wrist and one ankle for the measurement of cardiac output compared with the thermodilution method. DESIGN: Prospective, clinical investigation SETTING: Surgical intensive care unit of a university-affiliated community hospital. PATIENTS: Simultaneous cardiac output measurements by noninvasive whole-body impedance cardiography (nCO) and invasive thermodilution (thCO) in 22 high-risk surgical patients scheduled for extended surgery requiring perioperative pulmonary artery catheter monitoring. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 109 sets of measurements consisting of 455 single comparison measurements between nCO and thCO were included in the analysis. The mean cardiac output difference between the two methods was 1.62 L/min with limits of agreement (2 SD) of +/- 4.64 L/min. The inter-measurement variance was slightly higher for nCO. The correlation coefficient between nCO and thCO was r2 = 0.061 (p < .001) for single measurements and r2 = 0.083 (p < .002) for sets of three to six measurements. The two most predictive factors for between-method differences were the absolute thCO value (r2 = 0.13; p < .001) and whether or not a continuous nitroglycerin infusion was used (p < .05, Student's t-test). CONCLUSIONS: Agreement between whole-body impedance cardiography and thermodilution in the measurement of cardiac output was unsatisfactory. Factors that can explain these differences are differences between the populations used for calibration of nCO and the study population, the influence of changing peripheral perfusion, and the effect of a supranormal hemodynamic state on the bioimpedance signal. Whole-body impedance cardiography cannot be recommended for assessing the hemodynamic state of high-risk surgical patients as studied in this investigation.

Immediate hip spica casting for femur fractures in pediatric patients. A review of 175 patients.

Immediate closed reduction and application of a well-molded hip spica cast is a safe and effective treatment option for closed, isolated femur fractures in children who weigh between 10 and 100 pounds. Between 1988 and 1996, 190 immediate hip spica casts were placed on children with isolated femoral shaft fractures who weight between 10 and 100 pounds. Fifteen patients were lost to followup leaving 175 children who were evaluated and followed up for at least 2 years after the hip spica cast was removed (range 2-10 years). The femur fractures were reduced closed and placed in a 1 1/2 hip spica cast in the emergency room with the patient under conscious sedation or in the operating room with the patient under general anesthesia. All of the children returned home within 24 hours of the procedure. All 175 femur fractures united within 8 weeks. The only complication was a refracture in a 25 pound child who fell 1 week after the cast was removed. No significant residual angular deformities were present in any of the children at last followup. None of the children required external shoe lifts, epiphysiodesis, antibiotics, irrigation and debridements, or limb lengthening procedures for leg length inequalities. The authors think that immediate closed reduction and placement of a well-molded hip spica cast is a safe and reliable treatment option for isolated, closed femur fractures in children from birth to 10 years of age who weigh less than 80 pounds.

Leptin does not fully account for the satiety activity of adipose tissue-conditioned medium.

To determine whether leptin alone accounts for the satiety activity secreted by native adipose tissue, we prepared culture media conditioned by microdissected adipose tissue from overfed Long-Evans rats, fa/fa rats, or db/db mice (media A, B, and C, respectively). Medium A significantly suppressed food intake following intracerebroventricular delivery to Long-Evans rats (2-h chow intake = 68 +/- 5% of baseline, P < 0.001). Media B and C significantly suppressed food intake following intraperitoneal delivery to ob/ob mice (24-h chow intake = 56 +/- 7% of baseline for medium B, P = 0. 001; 4-day chow intake = 78 +/- 3% of baseline for medium C, P = 0. 004). Using a leptin receptor-based bioassay, we determined that the leptin concentration of medium C was 392 +/- 18 ng/ml. This concentration was 20-fold lower than the concentration of recombinant murine leptin required to produce a similar degree of feeding suppression following 5 days of administration to ob/ob mice. Neither medium conditioned by adipose tissue from ob/ob mice nor medium conditioned by adipose tissue from fa/fa rats and subsequently immunodepleted of leptin had significant satiety activity. We conclude that leptin is necessary but not sufficient to account for the satiety activity of native adipose tissue, perhaps due to the production by adipocytes of a cofactor that augments the ability of leptin to suppress feeding.

[Study methods of drugs in Alzheimer disease]. / Méthodes d'étude des médicaments dans la maladie de l'Alzheimer.

The availability of new drugs for Alzheimer's disease, with different pharmacological profiles, leads to a redefinition the relevant methodology for developing drugs in this indication, including the inclusion/exclusion criteria, the duration of the studies, and therefore, the relevant guidelines. This was the purpose of the Giens Round-table devoted to the new methodology for drug development in Alzheimer disease.

[Treatment of postoperative lung failure with prone positioning]. / Behandlung des postoperativen Lungenversagens mit Bauchlagerung.

Of forty-three consecutive patients with severe adult respiratory distress syndrome (ARDS) treated in the prone position pulmonary function improved significantly in 39 patients during the first 12 h in prone position. Changes were most pronounced in patients with high QS/QT, as well as in patients in the early stages of ARDS. Twenty-eight patients could be weaned from the ventilator, and 22 patients were able to leave the hospital. These results suggest that prone position has an important role in the overall therapeutic approach to ARDS and should be used as early as possible.

[Surgical therapy of esophageal cancer--early results]. / Die operative Therapie des Osophaguskarzinoms--Frühergebnisse.

PATIENTS AND METHOD: A prospective study was undertaken in 230 patients with carcinoma of the esophagus and of the cardia with infiltration of the distal oesophageal part from 1988 to 1993. RESULTS: According to postoperative UICC-classification 3% of patients had stage 0, 43% stage I/II and 54% stage III/IV. 162/230 were resected (resection rate 70.4%). 55% (89/162) of resected patients had thoracoabdominocervical, 38% (62) thoracoabdominal and 8% (11) transhiatal esophagectomy. Rate of anastomotic break-down was 1.9% (3/162). Clinical mortality decreased from 32% in 1988/89 to 11% in 1990/91 to at least 0% in 1992/93 (total 13%). CONCLUSION: Control of the postoperative phase is of decisive importance in decreasing mortality after esophageal resection, while surgical-technical problems seem to be solved. Esophagectomy is possible even as palliative measure in the presence of low mortality.

[Drill wire osteosynthesis in subcapital humerus fractures: percutaneous or open procedure?]. / Die Bohrdrahtosteosynthese bei subkapitalen Humerusfrakturen: Perkutanes oder offenes Vorgehen?

Between 1978 and mid-1990, 135 patients suffering from dislocated, non-luxated fracture of the humerus at the anatomical neck (fractura colli anatomici) were treated by means of open or closed percutaneous drill wire osteosynthesis. Follow-up examination after an average of 9 months did not show any significant differences between the two surgical approaches in 117 patients, independent of the shape of the fracture. However, in about 30% of the cases it was impossible to employ the percutaneous approach due to the presence of an obstacle to reduction, so that open reduction and fixation was the only choice. A great majority of the functional results must be considered as good, fractures of the tubercles having the most unfavourable prognosis independent of the surgical technique. It is, therefore, recommended to first try closed reduction with percutaneous drill wire osteosynthesis. If there are any obstacles to reduction, open reduction should be restored to during the surgery session.

[Contribution of sequential voluntary ambulatory monitoring in the diagnosis of arrhythmia. A multicenter study of 1287 symptomatic patients]. / Apport de l'enregistrement ambulatoire séquentiel volontaire à la détection des arythmies. Etude multicentrique sur 1,287 patients symptomatiques.

Voluntary sequential ambulatory recording is a diagnostic method of recording per-critical electrocardiographs in symptomatic patients with the aid of a portable solid-state technology recorder. In order to assess the value of this technique in the detection of arrhythmias, a multicenter study was performed in 1,287 symptomatic patients suspected of having paroxysmal arrhythmias (palpitations in 86.5% of cases). The quality of the sequential ambulatory recording was judged to be good in 54.9% and mediocre in 40.2% of cases: only 4.9% of recordings were uninterpretable. This technique allowed identification of a cardiac arrhythmia related to symptoms in 42.5% of the 1,091 cases which were analysed; sustained supraventricular tachycardia (11.7%), ventricular extrasystoles (14.9%) and simple sinus tachycardia (9.5%) were the principal abnormalities. The per-critical recording was negative in 57.5% of patients, suggesting a purely functional origin of symptoms in these cases. Atrial fibrillation was more common in hypertensive patients (11.3% vs 5.5% in normotensives, p less than 0.01) as were ventricular extrasystoles (23.1% vs 13% in normotensives, p less than 0.001). Voluntary sequential ambulatory recording seems to be a technique well adapted to the detection of symptomatic arrhythmias and a useful complement to Holter recording.

Factors affecting hip fracture mortality.

This retrospective analysis of 300 patients with proximal femoral fractures was undertaken to determine what factors were significant and nonsignificant in determining patient mortality. Mortality rates were based on survival of the patient 1 year after surgery. Of 283 patients followed until death or for at least 1 year postoperatively, the mortality rate was 14.8% (42/283). The expected mortality rate for the normal population over 50 years of age is 3%. Factors considered significant in influencing patient mortality were age, number of pre-existing medical conditions, postoperative level of ambulation, and delay of surgery for more than 24 h in relatively healthy patients. The authors feel that on the basis of this study, healthy patients should undergo surgery within 24 h of admission and less healthy patients can be stabilized medically before undergoing surgery without adding increased risk from the delay.

Experience with an intraoperative autogenous blood recovery system in scoliosis and spinal surgery.

A clinical trial of an intraoperative autogenous blood recovery system shows that while the method is safe, the cost in spinal surgery is quite high. The unit was used in 20 procedures in 18 patients thought to have increased risk of intraoperative bleeding (mature idiopathic, congenital, myelomeningocele, Marfan's, and irradiation scolioses and late spinal fractures). Collection in four procedures was either insufficient for use of contaminated. In the remaining 16 cases, 20% of the blood loss was recovered. A total of ten units of blood was recovered, at a cost of $283/unit; this is four times the current cost for a unit of blood in the local blood bank. The method would be more beneficial if a huge blood loss were anticipated, as most of its cost is incurred in the setup, and the higher the blood loss at surgery, the higher the percentage of the yield might be. The method may be useful with rate blood types and for patients with religious objections to transfusions.