IntroductionPerianal fistulising Crohn’s disease (pfCD) can be somewhat treatment refractory. Higher infliximab trough levels (TLIs) may improve fistula healing rates; however, it remains unclear whether escalating infliximab therapy to meet higher TLI targets using proactive, or routine, therapeutic drug monitoring (TDM) improves outcomes. This randomised controlled trial aimed to assess whether infliximab therapy targeting higher TLIs guided by proactive TDM improves outcomes compared with standard therapy.Methods and analysisPatients with active pfCD will be randomised 1:1 to either the proactive TDM arm or standard dosing arm and followed up for 54 weeks. Patients in the proactive TDM arm will have infliximab dosing optimised to target higher TLIs. The targets will be TLI ≥ 25 µg/mL at week 2, ≥ 20 µg/mL at week 6 and ≥ 10 µg/mL during maintenance therapy. The primary objective will be fistula healing at week 32. Secondary objectives will include fistula healing, fistula closure, radiological fistula healing, patient-reported outcomes and economic costs up to 54 weeks. Patients in the standard dosing arm will receive conventional infliximab dosing not guided by TLIs (5 mg/kg at weeks 0, 2 and 6, and 5 mg/kg 8 weekly thereafter). Patients aged 18–80 years with pfCD with single or multiple externally draining complex perianal fistulas who are relatively naïve to infliximab treatment will be included. Patients with diverting ileostomies or colostomies and pregnant or breast feeding will be excluded. Fifty-eight patients per arm will be required to detect a 25% difference in the primary outcome measure, with 138 patients needed to account for an estimated 6.1% primary non-response rate and 10% dropout rate.Ethics and disseminationResults will be presented in peer-reviewed journals and international conferences. Ethics approval has been granted by the South Western Sydney Local Health District Human Research Ethics Committee in Australia.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12621000023853); Pre-results.
Purpose To compare the biomechanical characteristics between diaphyseal and metaphyseal ulnar-shortening osteotomy with respect to (1) maximal shortening achieved at each osteotomy site and (2) force required to achieve shortening at each site. Methods Nine fresh frozen cadaveric upper extremities were affixed through the proximal ulna to a wooden surgical board. A metaphyseal 20-mm bone wedge was resected from the distal ulna and sequential shortening was performed. A load cell was attached to a distal post that was clamped to the surgical board and used to measure the force required for each sequential 5-mm of shortening until maximal shortening was achieved. The resected bone was reinserted, and plate fixation was used to restore normal anatomy. A 20-mm diaphyseal osteotomy was performed, and force measurements were recorded in the same manner with (1) interosseous membrane intact, (2) central band released, and (3) extensive interosseous membrane and muscular attachments released. Results Metaphyseal osteotomy allowed greater maximal shortening than diaphyseal osteotomy with the interosseous membrane intact and with central band release but similar shortening when extensive interosseous membrane and muscle release was performed. Force at maximal shortening was similar between metaphyseal and diaphyseal osteotomy. Sequential soft tissue release at the diaphysis allowed for increased shortening with slightly decreased shortening force with sequential release. Conclusion Metaphyseal ulnar osteotomy allows greater maximal shortening but requires similar force compared with diaphyseal osteotomy. Sequential release of the interosseous membrane permits increased shortening at the diaphysis but requires extensive soft tissue release. Clinical Relevance Both sites of osteotomy can achieve sufficient shortening to decompress the ulnocarpal joint for most cases of ulnar impaction syndrome. The greater shortening from metaphyseal ulnar osteotomy may be reserved for severe cases of shortening, especially after distal radius malunion or in the setting of distal radius growth arrest in the pediatric population. Level of Evidence This is a Level V, basic science study.
Background: The merits of a double-row rotator cuff repair (RCR) construct are well-established for restoration of the footprint and lateral-row security. The theoretical benefit of leaving the medial row untied is to prevent damage to the rotator cuff by tissue strangulation, and the benefit of suture tape is a more even distribution of force across the repair site. These benefits, to our knowledge, have not been evaluated in the laboratory. Hypothesis: Leaving the medial row untied and using a suture bridge technique with suture tape will offer more even pressure distribution across the repair site without compromising total contact force. Study Design: Controlled laboratory study. Methods: A laboratory model of RCR was created using biomechanical research-grade composite humeri and human dermal allografts. The pressure distribution in a double-row suture bridge repair construct was analyzed using the following testing matrix: double-loaded suture anchors with the medial row tied (n = 15) versus untied (n = 15) compared with double-loaded suture tape and anchors with the medial row tied (n = 15) versus untied (n = 15). A digital pressure sensor was used to measure pressure over time after tensioning of the repair site. A multivariate analysis of variance was used for statistical analysis with post hoc testing. Results: The total contact force did not significantly differ between constructs. The contact force between double-loaded suture anchors and double-loaded suture tape and anchors was similar when tied ( P = .15) and untied ( P = .44). An untied medial row resulted in similar contact forces in both the double-loaded suture anchor ( P = .16) and double-loaded suture tape and anchor ( P = .25) constructs. Qualitative increases in focal contact pressure were seen when the medial row was tied. Conclusion: An untied medial row did not significantly affect the total contact force with double-loaded suture anchors and with double-loaded suture tape and anchors. Tying the medial row qualitatively increased crimping at the construct’s periphery, which may contribute to tissue strangulation and hinder clinical healing. Qualitative improvements in force distribution were seen with double-loaded suture tape and anchors. Clinical Relevance: Both tied and untied medial rows demonstrated similar pressures across the repair construct.
The association between malignancy and tumour-related sarcoid reaction is well documented, characterised by non-caseating granulomatous disease in haematological and solid malignancies. Its occurrence in colon cancer is rare and of unclear clinical significance. Herein, we present a case report of a 32-year-old woman diagnosed with concurrent metastatic sigmoid colon adenocarcinoma and pulmonary granulomatous disease suggestive of a tumour-related sarcoid reaction.
A double-masked placebo-controlled clinical trial with hard data evaluation by image analysis of Scheimpflug photographs taken at baseline and 6, 12 and 18 months after starting treatment was performed to assess the efficacy of bendazac lysine in four different types of senile cataract. The study had a classical split-plot design. For statistical evaluation, the analysis of variance and covariance for repeated measures were used for three different lens sections: anterior capsule and superficial layer, anterior cortex and nucleus. In the entire group of 53 evaluable patients (without separation into cataract-type subgroups), there was a significantly less increase over time in light scattering (i.e. film blackening) of the anterior cortex and nucleus with bendazac lysine than with placebo. There was also a strong trend in favour of the active drug at the anterior capsular level. Patients with water clefts and spokes showed a significantly less light scattering of the anterior capsule and cortex when treated with bendazac lysine. Those with nuclear changes also showed significantly less light scattering of the anterior cortex and nuclear region with the active drug than with placebo. The number of patients with subcapsular and wedge-shaped (cuneiform) cataracts was too small to be adequately assessed by statistical procedures. Nevertheless, there were indications of a beneficial effect of bendazac lysine on all the lens sections in patients with subcapsular cataracts and on the anterior cortical region in those with wedge-shaped cataracts. In conclusion, this study showed that the increase in light scattering over time, i.e. the progression of cataract, is less in bendazac lysine-treated patients than in those treated with placebo.
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