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Study Design: Retrospective Observational Study. Objective: Mandibular condyle fractures are distinctive among maxillofacial injuries in which they disrupt mandibular function in a way that other traumatic injuries do not. Condylar fractures can be treated using either the conservative (closed reduction and immobilisation) or surgical (open reduction and internal fixation) approaches. Both of these modalities of treatment have advantages and disadvantages, as well as indications and contraindications. The purpose of this study is to compile and compare our experience in the management of condylar fractures through open and closed reduction. Methods: The present retrospective analysis included a total 100 patients of condylar fractures in patients > 18 years of age who were randomly divided into nonsurgical and surgical group based on Edward Ellies criteria. In the present study, the outcomes of conservative vs surgical management of condylar fractures were discussed in terms of seven parameters, including the maximal inter-incisal mouth opening, protrusive and lateral excursive movements of the mandible, status of occlusion, deviation of mandible during mouth opening, temporo-mandibular disorders and facial nerve paralysis which were measured and evaluated pre- and post-operatively at different intervals of time. Follow-up period was for 6 months. Results: It was noted that the main cause of condylar fracture was trauma with a male predilection with an average age of 32.6 ± 1.2 years. Subcondylar fracture was the commonest type of condylar fracture that we encountered. 33.3% of the patients had restricted mouth opening and 57% of the patients had deranged occlusion. 37% of the patients were treated surgically and 48.6% of these fractures were approached using peri-angular approach. More patients had an increased mouth opening and a stable occlusion at the 6 months follow-up when compared to that of the 2 month follow up. Conclusions: From the above study we can conclude that the treatment plan should be patient specific and follow the algorithm for a particular type of fracture. We endorse the same based on our experience in treating condylar fractures over the last 5 years. The art of decision making solely depends on the surgeon's expertise in managing condylar fractures.
RESUMO
BACKGROUND: Glutamate excitotoxicity might contribute to the pathophysiology of amyotrophic lateral sclerosis. In animal models, decreased excitatory aminoacid transporter 2 (EAAT2) overexpression delays disease onset and prolongs survival, and ceftriaxone increases EAAT2 activity. We aimed to assess the safety and efficacy of ceftriaxone for amyotrophic lateral sclerosis in a combined phase 1, 2, and 3 clinical trial. METHODS: This three-stage randomised, double-blind, placebo-controlled study was done at 59 clinical sites in the USA and Canada between Sept 4, 2006, and July 30, 2012. Eligible adult patients had amyotrophic lateral sclerosis, a vital capacity of more than 60% of that predicted for age and height, and symptom duration of less than 3 years. In stages 1 (pharmacokinetics) and 2 (safety), participants were randomly allocated (2:1) to ceftriaxone (2 g or 4 g per day) or placebo. In stage 3 (efficacy), participants assigned to ceftriaxone in stage 2 received 4 g ceftriaxone, participants assigned to placebo in stage 2 received placebo, and new participants were randomly assigned (2:1) to 4 g ceftriaxone or placebo. Participants, family members, and site staff were masked to treatment assignment. Randomisation was done by a computerised randomisation sequence with permuted blocks of 3. Participants received 2 g ceftriaxone or placebo twice daily through a central venous catheter administered at home by a trained caregiver. To minimise biliary side-effects, participants assigned to ceftriaxone also received 300 mg ursodeoxycholic acid twice daily and those assigned to placebo received matched placebo capsules. The coprimary efficacy outcomes were survival and functional decline, measured as the slope of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) scores. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00349622. FINDINGS: Stage 3 included 66 participants from stages 1 and 2 and 448 new participants. In total, 340 participants were randomly allocated to ceftriaxone and 173 to placebo. During stages 1 and 2, mean ALSFRS-R declined more slowly in participants who received 4 g ceftriaxone than in those on placebo (difference 0·51 units per month, 95% CI 0·02 to 1·00; p=0·0416), but in stage 3 functional decline between the treatment groups did not differ (0·09, -0·06 to 0·24; p=0·2370). No significant differences in survival between the groups were recorded in stage 3 (HR 0·90, 95% CI 0·71 to 1·15; p=0·4146). Gastrointestinal adverse events and hepatobiliary adverse events were more common in the ceftriaxone group than in the placebo group (gastrointestinal, 245 of 340 [72%] ceftriaxone vs 97 of 173 [56%] placebo, p=0·0004; hepatobiliary, 211 [62%] vs 19 [11%], p<0·0001). Significantly more participants who received ceftriaxone had serious hepatobiliary serious adverse events (41 participants [12%]) than did those who received placebo (0 participants). INTERPRETATION: Despite promising stage 2 data, stage 3 of this trial of ceftriaxone in amyotrophic lateral sclerosis did not show clinical efficacy. The adaptive design allowed for seamless transition from one phase to another, and central venous catheter use in the home setting was shown to be feasible. FUNDING: National Institute of Neurological Disorders and Stroke.