Topical application of povidone-iodine/dimethylsulfoxide ophthalmic gel preparation in Dutch-Belted rabbits.

Purpose: To determine the ocular and systemic toxicity of a novel, topically applied ophthalmic gel preparation of povidone-iodine (PVP-I) and dimethylsulfoxide (DMSO) in Dutch-Belted rabbits. Materials and Methods: Rabbits were administered doses of the test material or control by ocular instillation four times/eye/day, 7 d/week, for a minimum of 14 consecutive days. Dosing consisted of instillation of 50 µl of the appropriate test material solution or control material (saline) into each eye of the rabbit. On the last dose of the day, 250 µl of the appropriate test material solution or control material was applied to the eyelids of each eye. Results: Treatment-related clinical signs observed during the study were limited to mild non-inflammatory changes to the eyelids and eyelashes. There was no associated pathology upon histological examination of ocular or systemic tissues. Body weights and body weight gains were unaffected by treatment. Evaluation of clinical pathology profiles (haematology, coagulation, and clinical chemistry) did not reveal any test article-related toxicity and there were no macroscopic or microscopic findings at the terminal sacrifice. Conclusions: The compositions studied in the present investigation were developed to enable repeat-dosed application to the ocular surface and periocular skin surfaces without ocular, skin or systemic toxicity. The PVP-I/DMSO compositions tested did not cause any toxicity to the ocular surface or the periocular skin. Systemic toxicity from the preparations under study was not observed in any histological or gross pathological examination.

The functional intraoral Glasgow scale in floor of mouth carcinoma: longitudinal assessment of 62 consecutive patients.

The functional integrity of the floor of the mouth (FOM) is essential in maintaining tongue mobility, deglutition, and control and disposal of saliva. The present study focused on reporting oral function using functional intraoral Glasgow scale (FIGS) in patients who had surgical ablation and reconstruction of FOM carcinoma with or without chemo-radiotherapy. The study included patients who had surgical treatment of floor of mouth cancer in two regional head and neck units in Glasgow, UK between January 2006 and August 2007. Patients were assessed using FIGS before surgery, 2 months, 6 months and 1 year after surgery. It is a five-point scale self-questionnaire to allow patients to self-assess speech, chewing and swallowing. The maximum total score is 15 points. The influence of socio-demographic parameters, tumour characteristics and surgical parameters was addressed in the study. A total of 62 consecutive patients were included in the study; 41 (66.1 %) were males and 21 (33.9 %) were females. The patients' mean age at the time of diagnosis was 60.6 years. Fifty (80.6 %) patients had unilateral origin of FOM tumours and 10 (19.4 %) had bilateral origin. Peroral approach was the most common approach used in 35 (56.4 %) patients. The mean preoperative FIGS score was 14. Two months after surgery, it droped to 9.4 then started to increase gradually thereafter and recorded 10.1 at 6 months and 11 at 1 year. Unilateral FOM resection recorded better score than bilateral and lateral FOM tumours than anterior at 1 year postoperatively. Furthermore, direct closure showed better functional outcome than loco-regional and free flaps. The FIGS is a simple and comprehensive way of assessing a patient's functional impairment following surgery in the FOM. Tumour site and size, surgical access, surgical resection and method of reconstruction showed significant influence on oral function following surgical resection. A well-designed rehabilitation programme is required to improve oral function after surgical resection of oral cancer.

Type II Odontoid Fractures Case Series: History of Seizures a Risk Factor for Failure of Non-operative Treatment of Type II Odontoid Fractures.

Introduction: Odontoid fractures are one of the most common injuries to the cervical spine. Type II odontoid fracture treatment varies depending on age, co-morbidities, and fracture morphology. Treatment ranges from cervical orthosis to surgical intervention. CurrentlyAt present, fractures with high non-union rates are considered for operative management which includes displacement of >6 mm, increasing age (>40--60 years), fracture gap >1 mm, delay in treatment >4 days, posterior re-displacement >2 mm, increased angulation, and history of smoking. While re-displacement of >2 mm has been associated with increased risk of non-union;, to the best of our knowledge, no studies have looked at the risk factors for re-displacement. Case Report: We present two 26-year-old male patients who were found to have minimally displaced type II odontoid fractures initially treated in a cervical collar. These two patients were subsequently found to have displaced their odontoid fracture after having a documented seizure. Conclusion: We suggest that a history of seizures be considered a risk factor for re-displacement of non-displaced type II odontoid fractures.

The in vitro response of human osteoblasts to polyetheretherketone (PEEK) substrates compared to commercially pure titanium.

Polyetheretherketone (PEEK) is used as an alternative to titanium in medical devices. Previous in vitro studies examining PEEK have differed in their choice of polymer variant [PEEK or carbon-fiber reinforced PEEK (CFR-PEEK)], source of polymer (some of which are no longer available or for implantation) and cell type. While all studies demonstrated favorable cytocompatibility of the PEEK material, no studies are available which reflect the current state of the art of the material. Here, we use different forms of the only implantable grade PEEK available. These are compared with commercially pure titanium (cpTi) Grade 1 using a human primary osteoblast model. Sample materials were presented as industrially relevant surfaces. Machined or injection molded PEEK and CFR-PEEK were evaluated along with polished (Ra=0.200microm) and rough (Ra=0.554microm) cpTi. Osteoblast adhesion at 4h on injection molded variants of PEEK (Ra=0.095microm) and CFR-PEEK (Ra=0.350microm) material was comparable to titanium. Machined variants of PEEK (Ra=0.902microm) and CFR-PEEK (Ra=1.106microm) materials were significantly less. Proliferation at 48h determined by [(3)H]-thymidine incorporation was the greatest on the smoothest of all materials, the injection molded unfilled PEEK, which was significantly higher than the rough titanium control. The machined unfilled PEEK had the lowest DNA synthesis. RT-PCR for alkaline phosphatase, Type I collagen and osteocalcin normalized to glyceraldehyde-3-phosphate dehydrogenase revealed different patterns of mRNA levels. High mRNA levels for Type I collagen showed that CFR-PEEK stimulated osteoblast differentiation, whilst injection molded unfilled PEEK was less differentiated. Machined unfilled PEEK had comparable message levels of bone matrix proteins as rough titanium. All material variants permitted a degree of mineralization. Scanning electron microscopy at 3 days and 2 weeks in differentiation medium showed that human osteoblasts were well spread on all the different substrates. The varied response reported here at different time points during the study suggests that material formulation (unfilled PEEK or CFR-PEEK), subjection to industrial processing, surface roughness and topography may all influence the cellular response of osteoblasts to PEEK. Thus, differences in human osteoblast responses were found to the various samples of PEEK, but implantable grade PEEK, in general, was comparable in vitro to the bone forming capacity of rough titanium.

PEEK biomaterials in trauma, orthopedic, and spinal implants.

Since the 1980s, polyaryletherketones (PAEKs) have been increasingly employed as biomaterials for trauma, orthopedic, and spinal implants. We have synthesized the extensive polymer science literature as it relates to structure, mechanical properties, and chemical resistance of PAEK biomaterials. With this foundation, one can more readily appreciate why this family of polymers will be inherently strong, inert, and biocompatible. Due to its relative inertness, PEEK biomaterials are an attractive platform upon which to develop novel bioactive materials, and some steps have already been taken in that direction, with the blending of HA and TCP into sintered PEEK. However, to date, blended HA-PEEK composites have involved a trade-off in mechanical properties in exchange for their increased bioactivity. PEEK has had the greatest clinical impact in the field of spine implant design, and PEEK is now broadly accepted as a radiolucent alternative to metallic biomaterials in the spine community. For mature fields, such as total joint replacements and fracture fixation implants, radiolucency is an attractive but not necessarily critical material feature.

Anterolateral corridor approach to the infratemporal fossa and central skull base in maxillectomy: rationale and technical aspects.

We describe the technical aspects and report our clinical experience of a surgical approach to the infratemporal fossa that aims to reduce local recurrence after operations for cancer of the posterior maxilla. We tested the technique by operating on 3 cadavers and then used the approach in 16 patients who had posterolateral maxillectomy for disease that arose on the maxillary alveolus or junction of the hard and soft palate (maxillary group), and in 19 who had resection of the masticatory compartment and central skull base for advanced sinonasal cancer (sinonasal group). Early proximal ligation of the maxillary artery was achieved in all but one of the 35 patients. Access to the infratemporal fossa enabled division of the pterygoid muscles and pterygoid processes under direct vision in all cases. No patient in the maxillary group had local recurrence at median follow up of 36 months. Four patients (21%) in the sinonasal group had local recurrence at median follow up of 27 months. Secondary haemorrhage from the cavernous segment of the internal carotid artery resulted in the only perioperative death. The anterolateral corridor approach enables controlled resection of tumours that extend into the masticatory compartment.

Patterns of local recurrence after primary resection of cancers that arise in the sinonasal region and the maxillary alveolus.

Local recurrence remains the most important sign of relapse of disease after treatment of advanced cancer of the maxilla and sinonasal region. In this retrospective study we describe patterns of recurrence in a group of patients who had had open resection for cancer of the sinonasal region and posterior maxillary alveolus with curative intent. Casenotes and imaging studies were reviewed to find out the pattern of any relapse, with particular reference to local recurrence. The minimum follow-up period was 12 months. Of 50 patients a total of 16 developed recurrences, 11 of which were local. Of those 11, a total of 8 were in posterior and superior locations (the orbit, the infratemporal and pterygopalatine fossas, the traversing neurovascular canals of the body of the sphenoid to the cavernous sinus, the Gasserian ganglion, and the dura of the middle cranial fossa). Advanced cancer of the midface often equates with disease at the skull base. Treatment, including surgical tactics, should reflect that.

Pre-operative evaluation of vascularised fibula donor sites: a UK maxillofacial e-survey.

The vascularised fibula flap has been used in mandibular reconstruction for three decades. An e-survey of pre-operative lower limb evaluations being utilised by UK maxillofacial head and neck surgeons was carried out in order to gauge if there was any uniformity in practice. Our results show that routine pre-operative evaluation is the expected standard but the modalities used vary among the different units. The results compare favourably with previous published figures.

Cervical disc replacement in patients with and without previous adjacent level fusion surgery: a prospective study.

STUDY DESIGN: Prospective 6-center study. OBJECTIVE.: To evaluate outcomes of cervical disc replacement performed adjacent to a prior cervical fusion. SUMMARY OF BACKGROUND DATA: The use of disc replacement adjacent to a prior anterior cervical decompression and fusion (ACDF) is an attractive reconstructive option, obviating the need for a multilevel fusion. This study reports outcomes from patients with and without previous ACDF receiving the porous coated motion (PCM) artificial cervical disc in a United States Federal Drug Administration Investigational Device Exemption trials. METHODS: Patients between ages of 18 and 65 with single-level cervical radiculopathy and/or myelopathy, unresponsive to at least 6 weeks of nonsurgical therapy, or experiencing progressive neurologic symptoms were enrolled. Clinical outcomes are compared for patients receiving a PCM disc at a level adjacent to a prior ACDF ("adjacent") and those without having previously had fusion ("primary"). RESULTS: 126 PCM patients were primary (mean age: 44.4 years.) and 26 patients had previous "adjacent level" fusion surgery (mean age: 46.4 years). Surgery time was similar in both groups (96 minutes and 98 minutes, respectively; P = 0.761), and mean blood loss was 76 mL and 66 mL in the 2 groups, respectively (P = 0.491). Clinical outcomes using Neck Disability Index and Visual Analog Scores neck and arm scores showed significant improvement after surgery and were similar between groups at all time points. Revision surgery occurred in 2 of 126 primary patients, and in 2 of 26 patients in the adjacent-to-fusion group. CONCLUSION: Although the level adjacent to a prior cervical fusion is subject to increased biomechanical forces, potentially leading to a higher risk of failure, the PCM disc was well tolerated in the short term. The early clinical results of disc replacement adjacent to a prior fusion are good and comparable to the outcomes after primary disc replacement surgery. However, in view of the small study population and short-term follow-up, continued study is mandatory.

Longitudinal health-related quality of life after mandibular resection for oral cancer: a comparison between rim and segment.

BACKGROUND: Mandibular resection for oral cancer is often necessary to achieve an adequate margin of tumor clearance. Segmental mandibulectomy has been associated with a poor health-related quality of life (HRQOL), particularly before composite free tissue transfer to reconstruct the defect. Little is published in the literature contrasting the subjective deficit of segmental compared with rim resection. The aim of this study was to use a validated head and neck HRQOL questionnaire to compare rim and segmental mandibular resection in patients having primary surgery for oral cancer. METHOD: There were 224 consecutive patients between 1995 and 1999 who were treated by primary surgery for oral squamous cell carcinoma. One hundred twenty-tree had no mandibular resection, 44 had a rim resection, and 57 had a segmental resection. The University of Washington Quality of life questionnaire (UW-QOL) was administered before treatment, at 6 months, 12 months and after 18 months. RESULTS: Preoperatively, patients undergoing segmental resection reported significantly more pain, chewing problems, and a lower composite UW-QOL score. Postoperatively, the segment group tended to score worse at all time points, particularly in appearance, swallowing, recreation, and chewing; however, the difference between rim and segment was only seen in smaller resections without adjuvant radiotherapy. Little difference was seen between rim or segment for tumors < 4 cm with radiotherapy and between rim and segments for tumors > 4 cm. CONCLUSION: After segmental mandibulectomy and reconstruction using composite free tissue transfer, the UW-QOL scores were relatively good. The only 2 difference between rim and segments was noted in the small resections without radiotherapy, and some of this was reflected in differences at baseline.