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© 2015 Osteoarthritis Research Society International. The ability to assess the efficacy and effectiveness of an intervention for the treatment of hip osteoarthritis (OA) requires strong clinical trial methodology. This consensus paper provides recommendations based on a narrative literature review and best judgment of the members of the committee for clinical trials of hip OA. We provide recommendations on clinical trial design, outcome measures, including structural (radiography), and patient and physician global assessments, performance based measures, molecular markers and experimental endpoints including MRI imaging. This information can be utilized by sponsors of trials for new therapeutic agents for hip OA.

Summary Objective This publication summarizes the clinical development of the compound SAR113945, an IκB kinase inhibitor injected intra-articularly in a slow-release formulation to treat patients with symptomatic osteoarthritis (OA) of the knee. Results In vitro experiments demonstrated a specific inhibition of the IκB kinase complex. Profiling of SAR113945 on kinases, enzymes and ion channels supported the initiation of a clinical development. Cellular assay systems also revealed an inhibition in the synthesis of interleukin 1β, tumor necrosis factor α (TNFα) and the prostaglandin E2 (PGE 2 ). In vivo studies demonstrated positive effects of SAR113945 on thermal and mechanical hyperalgesia and even showed superiority in comparison with triamcinolone. Pharmacokinetic measurements showed a sustained release of dissolved SAR113945 locally supporting a comparably high exposure in the knee joint combined with a low systemic exposure. Three phase 1 studies with a dose-escalating design confirmed safety and tolerability of SAR113945. In those studies SAR113945 showed a positive trend on the WOMAC scores. The proof-of-concept or phase 2a study failed to show any effect in the overall group of recruited study participants for the primary endpoint, the WOMAC pain subscore at day 56, but showed a statistically significant difference in a subgroup of patients who had presented with effusion at baseline. Conclusion Inhibiting the NFκB signaling pathway is an attractive method to treat patients with signs and symptoms of OA. The preclinical work and the results of the phase 1 studies appeared promising for a full clinical development, however, the proof-of-concept study failed to show efficacy in a larger patient sample size.

Between 1985 and 1997, we performed a locoregional chemotherapy in 59 patients suffering from non-resectable liver metastases of breast cancer. 36 of them only had liver metastases, in 23 patients liver metastases were combined with extrahepatic tumor spread. Furthermore, in 7 patients locoregional chemotherapy was used as a adjuvant regimen after metastasectomy. The average age of our patients was 52 (32-81) years. In most of our patients, a cytostatic scheme of mitoxantron, 5-fluorouracil and doxorubicin or a scheme of vincristin, mitomycin and mitoxantron was administered. The median survival of all patients was 11 months, in the patients with no additional extrahepatic tumor spread it was 16, in the patients with extrahepatic metastases 3 months, respectively.

We report on a patient who suffered chylothorax 2 months after she had undergone internal fixation of a fracture of her 12th thoracic vertebral body. The pleural effusion was treated by insertion of a chest tube. The chylothorax was managed conservatively. The patient received protein-rich nutrition supplemented with medium-chain triglycerides. As the volume of chylous fluid drained from the pleura had not decreased after 2 weeks, the patient received total parenteral nutrition without any oral intake of calories. Chest X-rays documented the disappearance of the chylothorax. Reexpansion of the lungs was noted, and the costophrenic sinuses could be clearly visualised.

The three osseous parts of the human pelvis form a continuous structure because of the symphysis and both iliosacral joints that-owing to their mobility-make possible a shock-absorption of vertical forces. The goal in the treatment of ruptures of the symphysis and/or of the sacroiliac joints is the restoration of functioning joints. Especially in the adolescent, a stiffening of these joints has to be avoided. Therefore, we treat ruptures of the pelvic joints with an overbridging banding that preserves the function of shock absorption. Due to utilisation of a banding, made up of polydioxanone, another operation to remove internal fixation material is not necessary. Rupture of the symphysis or iliosacral joint in the pediatric patient is very rare. Only three among the 67 patients whom we operated on because of a rupture of the symphysis or iliosacral joints between 1984 and 1990 were children. These were an eleven-year-old girl and a nine-year-old boy, who had suffered a rupture of the symphysis, and an eight-year-old boy with a disrupted iliosacral joint. In these children a banding with PDS suture was performed. At a follow-up examination, the children were free from pain and did not feel restricted in their daily routine or their physical activities.