A comparative assessment of small-head metal-on-metal and ceramic-on-polyethylene total hip replacement.

Large-head metal-on-metal (MoM) total hip replacements (THR) have given rise to concern. Comparative studies of small-head MoM THRs over a longer follow-up period are lacking. Our objective was to compare the incidence of complications such as infection, dislocation, revision, adverse local tissue reactions, mortality and radiological and clinical outcomes in small-head (28 mm) MoM and ceramic-on-polyethylene (CoP) THRs up to 12 years post-operatively. A prospective cohort study included 3341 THRs in 2714 patients. The mean age was 69.1 years (range 24 to 98) and 1848 (55.3%) were performed in women, with a mean follow-up of 115 months (18 to 201). There were 883 MoM and 2458 CoP bearings. Crude incidence rates (cases/1000 person-years) were: infection 1.3 vs 0.8; dislocation 3.3 vs 3.1 and all-cause revision 4.3 vs 2.2, respectively. There was a significantly higher revision rate after ten years (adjusted hazard ratio 9.4; 95% CI 2.6 to 33.6) in the MoM group, and ten of 26 patients presented with an adverse local tissue reaction at revision. No differences in mortality, osteolysis or clinical outcome were seen. In conclusion, we found similar results for small-head MoM and CoP bearings up to ten years post-operatively, but after ten years MoM THRs had a higher risk of all-cause revision. Furthermore, the presence of an adverse response to metal debris seen in the small-head MOM group at revision is a cause for concern.

Influence of patient activity on femoral osteolysis at five and ten years following hybrid total hip replacement.

We conducted a longitudinal study including patients with the same type of primary hybrid total hip replacement and evaluated patient activity and femoral osteolysis at either five or ten years post-operatively. Activity was measured using the University of California, Los Angeles scale. The primary outcome was the radiological assessment of femoral osteolysis. Secondary outcomes were revision of the femoral component for aseptic loosening and the patients' quality of life. Of 503 hip replacements in 433 patients with a mean age of 67.7 years (30 to 91), 241 (48%) were seen at five and 262 (52%) at ten years post-operatively. Osteolytic lesions were identified in nine of 166 total hip replacements (5.4%) in patients with low activity, 21 of 279 (7.5%) with moderate activity, and 14 of 58 (24.1%) patients with high activity. The risk of osteolysis increased with participation in a greater number of sporting activities. In multivariate logistic regression adjusting for age, gender, body mass index and the inclination angle of the acetabular component, the adjusted odds ratio for osteolysis comparing high vs moderate activity was 3.6 (95% confidence interval 1.6 to 8.3). Stratification for the cementing technique revealed that lower quality cementing increased the effect of high activity on osteolysis. Revision for aseptic loosening was most frequent with high activity. Patients with the highest activity had the best outcome and highest satisfaction. In conclusion, of patients engaged in high activity, 24% had developed femoral osteolysis five to ten years post-operatively.

[Autologous chondrocyte implantation for focal cartilage lesions: state of the art in 2007]. / Implantation de chondrocytes autologues pour les lésions cartilagineuses focales: le point en 2007.

Autologous chondrocyte implantation (ACI) is a frequently used procedure for full-thickness cartilage lesions in the knee joint. However, to date, there are just a few prospective, randomized clinical studies and most publications are case series on small and heterogenic cohorts with short-term follow-up. To date, ACI is a surgical treatment option for single traumatic lesions on the distal femur in young active subjects with a recent lesion. Lesion size should be between 3 and 8 cm2, < 6 mm in depth, tidemark preserved without penetration of the subchondral bone. Absolute contraindications for ACI include osteoarthrosis, kissing lesions, lesions size greater than 10 cm2 or deeper than 8 mm, ligament instability, partial or total meniscectomy, axis malalignment > 5. Further studies are mandatory to determine the precise indications to the technique and to show its superiority on the established treatment of chondral lesions.

Diagnosis of occult scaphoid fracture with high-spatial-resolution sonography: a prospective blind study.

BACKGROUND: Evaluation of diagnostic accuracy of high-spatial-resolution sonography (HSR-S) in occult scaphoid fractures. PATIENTS AND METHODS: HSR-S was performed in 24 patients with clinically suspected fracture and normal radiographs. Three levels of clinical suspicion were considered (high, intermediate, and low). Three levels of sonographic suspicion were defined on the basis of cortical interruption, radiocarpal effusion, and scapho-trapezium-trapezoid effusion. Three positive criteria were interpreted as being highly indicative of fracture. Data from sonograms were compared with computed tomography (CT) scans. RESULTS: CT scanning demonstrated a fracture of the scaphoid in five patients. The global sensitivity of HSR-S for detection of occult scaphoid fracture was 100% and the specificity 79%. All patients with demonstrated occult fracture had a high sonography index of suspicion. A high sonography index of suspicion was correlated with 100% sensitivity, specificity, positive predictive value, and negative predictive value. CONCLUSION: HSR-S is a reliable, available, and cost-effective method in early diagnosis of occult fractures of the scaphoid. The presence of three defined criteria is required to assess the diagnosis.

COX-1 and COX-2 inhibition in horse blood by phenylbutazone, flunixin, carprofen and meloxicam: an in vitro analysis.

We report on the inhibitory activity of the NSAIDs meloxicam, carprofen, phenylbutazone and flunixin, on blood cyclooxygenases in the horse using in vitro enzyme-linked assays. As expected, comparison of IC50 indicated that meloxicam and carprofen are more selective inhibitors of COX-2 than phenylbutazone and flunixin; meloxicam was the most advantageous for horses of four NSAIDs examined. However at IC80, phenylbutazone (+134.4%) and flunixin (+29.7%) had greater COX-2 selectivity than at IC50, and meloxicam (-41.2%) and carprofen (-12.9%) had lower COX-2 selectivity than at IC50. We therefore propose that the selectivity of NSAIDs should be assessed at the 80% as well as 50% inhibition level.

The Quality Assurance programme of the Radiotherapy Group of the European Organization for Research and Treatment of Cancer (EORTC): a critical appraisal of 20 years of continuous efforts.

In 1982, the European Organization for Research and Treatment of Cancer (EORTC) Radiotherapy Group established the Quality Assurance (QA) programme. During the past 20 years, QA procedures have become a major part of the activities of the group. The methodology and steps of the QA programme over the past 20 years are briefly described. Problems and conclusions arising from the results of the long-lasting QA programme in the EORTC radiotherapy group are discussed and emphasised. The EORTC radiotherapy group continues to lead QA in the European radiotherapy community. Future challenges and perspectives are proposed.

Clinical impact of dosimetry quality assurance programmes assessed by radiobiological modelling of data from the thermoluminescent dosimetry study of the European Organization for Research and Treatment of Cancer.

The European Organization for Research and Treatment of Cancer (EORTC) Radiotherapy Group initiated its mailed thermoluminescence dosimetry (TLD) programme in 1986. The aim of the present study was to evaluate the clinical relevance of variations in beam output detected in the period 1993 to 1996. A total of 140 beam outputs were checked (26 for cobalt-60 units and 114 for linear accelerators) in 35 centres. Clinical dose-response data for tumour control and normal tissue morbidity were used to assess the variation in clinical outcome resulting from variability in beam output. For 75 checked beams with nominal accelerating potentials (n. a.p.) of 6 MV or less the mean ratio, +/- standard deviation (S.D.) of measured to stated output was 1.004+/-0.020. For 65 beams with n. a.p. of 8 MV or more, the ratio was 1.009+/-0.021. Even with this relatively high level of precision, broad distributions of estimated tumour control or normal tissue morbidity were found. In the 10% of the beams with the most pronounced underdosage, the loss in tumour control probability was estimated at 7-8 percentage points. Likewise, in the 10% of the beams with the most pronounced overdosage, the increase in mild/moderate morbidity was 19-22 percentage points. For severe morbidity the same beams raised the estimated incidence of severe complications from 5% to 9-10%. An estimation of the loss of uncomplicated cure probability was about 1% for both high and low energy beams. Sequential mailings considerably improved the uniformity of clinical outcome. We conclude that small deviations in beam output may lead to clinically important variations in outcome. Substantial reductions in the variation between measured and stated output can be achieved by sequential mailings. Mailed TLD checks should be an integral part of a continuously ongoing quality assurance activity in radiotherapy.

Quality assurance of the EORTC radiotherapy trial 22931 for head and neck carcinomas: the dummy run.

PURPOSE: A dummy run was organized to test the compliance of participating centres with the guidelines of EORTC protocol 22931, which compares high dose radiotherapy with concomitant radiochemotherapy in a postoperative setting for patients presenting with locally advanced head and neck carcinomas. METHODS: In a first step the participants (seven centres, six replies) were asked to define the planning target volume (PTV) in a given patient on the basis of clinical, surgical and radiological (CT-images) data-sets and according to the protocol guidelines. In a second phase a series of CT-reconstructed slices with on- and off-axis PTV outlines were sent to 11 centres (10 replies), which were asked to plan a treatment following the recommendations made in the frame of the trial. RESULTS: The first step of this dummy run emphasized wide intercentre variations in PTV extensions. This fact raises the question of the reproducibility when pooling patients in multicentric trials. The second step indicated a large variability in the field arrangements which was left to the discretion of the investigators. Only three out of 10 of the institutions followed the ICRU 50 recommendations for dose reporting. Moreover, protocol requirements were not met for dose distribution homogeneity in any centre. CONCLUSIONS: In order to reduce intercentre treatment heterogeneities, several actions have been taken by the EORTC Radiotherapy Group, e.g. amendments have been brought to protocol 22931 regarding a better definition of clinical and planning target volumes. Furthermore, a stricter application of the ICRU 50 recommendations for dose reporting has been sought.

Quality assurance in radiotherapy: the importance of medical physics staffing levels. Recommendations from an ESTRO/EFOMP joint task group.

The safe application of ionising radiation for diagnosis and therapy requires a high level of knowledge of the underlying processes and of quality assurance. Sophisticated modern equipment can be used effectively for complicated diagnostic and therapeutic techniques only with adequate physics support. In the light of recent analyses and recommendations by national and international societies a joint working group of representatives from ESTRO (European Society for Therapeutic Radiology and Oncology) and from EFOMP (European Federation of Organisations for Medical Physics) was set up to assess the necessary staffing levels for physics support to radiotherapy. The method used to assess the staffing levels, the resulting recommendations and examples of their practical application are described.

Wedge factors: dependence on depth and field size.

Wedge factor (WF) variation with field size and depth has been analysed for 6 and 15 MV X-ray beams. The measured field size effect is 1.4% in the worst case, whereas the WF shows a linear dependence with depth giving a maximum variation of 0.22%/cm (60 degrees wedge, 6 MV beam). An empirical correction for WF depth dependence on wedge thickness is proposed.

Quality assurance of the EORTC radiotherapy trial 22863 for prostatic cancer: the dummy run.

The results of a dummy run involving nine centers participating in a study comparing radiotherapy alone with radiotherapy plus hormone therapy in patients with high metastatic risk prostatic cancer (EORTC protocol 22863) show that, in all centers but one, patients are treated in the same way. However, they have also indicated that protocol compliance could be improved by a better assessment of the target volume, by taking into account of the use of protective shields and of variations in radiological density, by determining beam position on a large number of slices, and by the use of CT scan images for treatment planning.

EORTC guidelines for writing protocols for clinical trials of radiotherapy.

The concept of a Master Protocol for phase III studies was raised at the Steering Committee of the EORTC Radiotherapy Group, in order to make the work of the study coordinators easier, when writing protocols and to give them more homogeneity. The Master Protocol defines and clarifies in a logical order the different steps which must be taken when designing a randomized trial--from the rationale to the references. It pays particular attention to eligibility criteria, volumes of interest defined in agreement with ICRU Report 50 (gross tumor volume, clinical target volume, planning target volume and organs at risk), simulation procedure, treatment technique, normal tissue sparing, dose computation, equipment, dose specification (also in agreement with ICRU Report 50). Last but not least, the different procedures of quality assurance for protocols and patients are also defined (site visits, dummy run procedure, in vivo dosimetry, individual case review) to allow working plans to be made in advance. We are aware that this work is not exhaustive, but hope that the contents will be of help to those who are writing a protocol.

[Neonatal choledocholithiasis: a case report]. / Coledocolitiasi neonatale: descrizione di un caso.

Cholelithiasis as cause of jaundice in newborn is rare. Usually is associated with known predisposing factors as hemolysis, congenital anomalies of biliary tree, total parenteral nutrition, prolonged fasting. However there are recent signals in literature about idiopathic neonatal cholelithiasis, that seems to be more common than previously suspected. We describe a case of idiopathic neonatal choledochal lithiasis with spontaneous resolution in few days from jaundice beginning. The importance of ultrasonographic investigation for diagnosis and follow-up is confirmed. However, because it is often a self limiting phenomenon, an aggressive approach is not warranted in the asymptomatic infant.

Comparison of diastolic left ventricular filling and cardiac dysrhythmias in hypertensive patients with and without isolated septal hypertrophy.

Although many patients with hypertension develop isolated septal hypertrophy (ISH) rather than concentric or eccentric left ventricular (LV) hypertrophy, limited data are available on cardiac structure, function, and arrhythmias in hypertensive patients with ISH. Clinical features, hemodynamics, M-mode echocardiograms, and 24-hour electrocardiographic recordings were evaluated in 21 healthy normotensive subjects, 23 hypertensive patients without LV hypertrophy, 31 hypertensive patients with concentric LV hypertrophy, and 23 hypertensive patients with ISH to determine the prevalence and complexity of cardiac arrhythmias and diastolic LV filling abnormalities. Age, sex, race, obesity indexes, preload, ejection fraction, and LV contractility were similar in all 4 groups, and arterial pressure and afterload were statistically similar in the 3 hypertensive groups. Left atrial emptying index (p < 0.01) and peak LV filling rate (p < 0.01), 2 indexes of diastolic LV filling, were significantly reduced in the 3 hypertensive groups compared with the normotensive group. The duration of rapid LV filling, however, was significantly prolonged only in hypertensive patients with concentric LV hypertrophy and ISH (p < 0.05) but not in hypertensive patients without LV hypertrophy. The prevalence (p < 0.001) and complexity (p < 0.001) of ventricular ectopic activity was also significantly increased to a similar degree in hypertensive patients with concentric LV hypertrophy and in those with ISH compared with normotensive subjects or hypertensive patients without LV hypertrophy. The prevalence and complexity of atrial ectopic activity was only increased significantly (p < 0.001) in those with ISH.

Improved dose distribution homogeneity in conservative breast cancer irradiation.

At the occasion of recent meetings of the radiation oncology community, the description of a whole breast irradiation technique making use of cranio-caudal oriented wedge filters to compensate for dose distribution inhomogeneity in this direction has given rise to some discussions and misunderstandings. It is the scope of this presentation to describe the technique and its possible use for other localizations.