[ITAP - 6-month results of a prospective, randomised phase 3 study for evaluation of the combination therapy of PDT and intravitreal triamcinolone in exudative AMD]. / ITAP - 6-Monats-Ergebnisse einer prospektiven und randomisierten Phase-3-Studie zur Evaluation der Kombinationstherapie aus PDT und intravitrealem Triamcinolon bei der exsudativen AMD.

BACKGROUND: Combination therapy of photodynamic therapy (PDT) with intravitreal triamcinolone (IVTA) for choroidal neovascularisation (CNV) in age-related macular degeneration is thought to improve the prognosis. It is therefore widely used, although results are mostly based upon non-randomised and retrospective studies. Here we present the 6-month results of our prospective, randomised, multicentre ITAP trial (Intravitreal Triamcinolone and PDT) for the evaluation of the combination therapy as compared to PDT alone. PATIENTS: This prospective, randomised, multicentre phase III trial was performed for the evaluation of the efficacy and safety of combination therapy (PDT and IVTA) as compared to PDT alone. Three randomised therapy groups (A: PDT alone, B: IVTA on the same day 1 hour after PDT C: IVTA 1 week before PDT) were monitored over 1 year. The patients included had wet AMD with predominantly classic CNV, minimal classic CNV smaller than 4 papillary diameters or occult CNV with recent disease progression. Re-treatment was performed when persistent leakage of the CNV was visible at follow-up. Primary outcome criteria were the comparison between combination therapy and PDT monotherapy concerning visual acuity, and, second, the comparison between the two groups of combination therapy. RESULTS: 92 patients were included in the study. Before treatment, mean best corrected ETDRS letter score was 52, 53 and 51 in groups A, B and C, respectively. At the 6 months follow-up, mean best corrected letter score was 40, 47 and 47, respectively, with only group A loosing more than 10 letters. This change, however, was not statistically significant between the groups. Mean retinal thickness as measured with optical coherence tomography decreased in all groups, and reached statistical significance in both combination groups. Re-treatment rates did not differ significantly between the three groups at 6 months follow-up, nor was there a significant cataract progression requiring operation. CONCLUSION: At 6 months there was no significant difference between mono- and combination therapy groups concerning visual acuity.

[Minimally invasive plating osteosynthesis of proximal humeral shaft fractures with long PHILOS plates]. / Minimal-invasive plattenosteosynthese proximaler humerusschaftfrakturen mittels langer PHILOS-platte.

OBJECTIVE: Closed reduction and minimally invasive stabilization of proximal humeral shaft fractures with long PHILOS plates. The presented technique enables stable extramedullary fixation of the fractures without affecting surrounding nerves. INDICATIONS: Proximal humeral shaft fractures that may not be fixed by intramedullary nailing because of a narrow, deformed or occupied intramedullary canal or because of open growth plates. CONTRAINDICATIONS: Fractures that may not be reduced adequately by traction or with percutaneous techniques. Furthermore, fractures with delayed or nonunion and pseudarthrosis should not be treated with this technique. SURGICAL TECHNIQUE: An anterolateral delta split approach is used to create an epiperiosteal tunnel along the humeral shaft from proximally to distally. A second incision is made distally at the lateral border of the biceps muscle. The brachialis muscle is dissected longitudinally. The PHILOS plate is twisted so that the proximal part of the plate can be placed laterally and the distal part anterolaterally at the humeral shaft. The plate is inserted into the epiperiostal tunnel and fixed with percutaneous screws. POSTOPERATIVE MANAGEMENT: The arm is immobilized in a Gilchrest bandage until wounds are healed. Active-assisted physiotherapeutic mobilization without loading starts on the first postoperative day. Active mobilization starts 8-12 weeks postoperatively. In cases of soft tissue irritation the PHILOS plate may be removed after 1 year. RESULTS: Between 2005 and 2011 a total of 16 patients (8 women and 8 men) were treated with the presented technique. The patients mean age was 61 years. According to the AO classification, five fractures were classified as type A, eight as type B and three fractures as type C. All patients had clinical and radiological follow-up examinations after a mean of 24 months (12-38 months). All fractures showed complete bony consolidation at the final follow-up. The mean Constant-Murley score was 81 points representing 84% of the Constant-Murley score of the healthy contralateral shoulder. The average DASH score was 33 points and the mean SF36 was 85 points.