The first knee prosthesis to go through beyond compliance: A new standard for the safe introduction of orthopaedic implants.

INTRODUCTION: Beyond Compliance (BC) was introduced in 2012 to improve the monitoring and regulation of new medical devices and techniques, ensuring patient safety whilst promoting innovation through an evidence based appraisal of devices during their introduction. This study reports the 2 year outcomes of the first Total Knee Replacement (TKR) implant to be assessed through the BC process. METHODS: 100 consecutive patients undergoing primary knee arthroplasty were enrolled. All patients received a single radius cruciate retaining TKA (Unity, Corin), and the patella was resurfaced in all cases. Patients were followed up at 6 weeks, 3, 6, 12 and 24 months post operatively. Pre-and post-operative range of movement (ROM) as well as outcome scores including OKS, KOOS, EQ5D index and EQ5D VAS were recorded. RESULTS: 100 patients with a mean age 73.6 (SD = 8.7) were included. 2 patients died during the follow-up period due to unrelated reasons. Overall satisfaction rates were 96%. Complications included ongoing pain (5 patients), and a periprosthetic fracture (1 patient) nine months post-surgery (traumatic). No knees were revised during the follow-up period. Significant improvements were observed in all outcomes measures (OKS, KOOS, EQ5D, and EQ5D VAS). The mean added ROM was 13.2°. DISCUSSION: This knee prosthesis has been demonstrated to be safe and effective with excellent early outcomes. The careful regulated introduction of this device through BC has ensured patients safety while supporting innovation in knee arthroplasty. The success of BC requires surgeons to insist industry fully engage with the process for all new devices or techniques.

Preliminary evaluation of a hydrogel liquid bandage in 30 dogs undergoing tibial plateau levelling osteotomy surgery.

AIMS: To compare the prevalence of minor incisional complications in canine patients undergoing tibial plateau levelling osteotomy (TPLO) surgery that had a hydrogel liquid bandage (HLB) applied to their incision, with patients that had a light adhesive bandage applied. METHODS: Thirty dogs undergoing TPLO surgery were randomly assigned to either application of a light adhesive bandage to the incision, with removal 18-24 hours later, or application of a clear-drying polyethylene glycol HLB to the incision. Erythema, swelling, discharge, and dehiscence were assessed 1 day (Day 1) and 10-14 days (Days 10-14) postoperatively. All persons completing the assessment were blinded to the treatment. Outcomes were compared for the two groups using Fisher's Exact Test. RESULTS: On both Day 1 and Days 10-14, the distribution of dogs with erthemyma or swelling did not differ between the two groups (p≥0.4). The prevalence of erythema was the same in the bandage and HLB groups at Day 1 (11/15; 73%) and was similar at Days 10-14 (3/11 (27%) and 2/11 (18%), respectively). Prevalence of swelling was also the same in the two groups on Day 1 (11/15; 73%) and was similar at Days 10-14 (3/11 (27%) and 6/11 (55%), respectively). On Day 1, 2/15 (13%) dogs in the HLB group and none of the dogs in the bandage group had incisional discharge (p=0.483). No dogs were observed with discharge on Days 10-14. No dehiscence, infection, or any other major incisional complication was observed in either group at any point in the study. CONCLUSIONS: Preliminary results suggest that prevalence of minor incisional complications after TPLO surgery treated with HLB or with a traditional adhesive bandage may be comparable. No major adverse effects were seen with the use of HLB. CLINICIAL RELEVANCE: Due to several disadvantages of traditional bandaging, which can require post-operative maintenance and removal, lasts only a short time, and be painful when removed, an alternative with fewer drawbacks is desirable. HLB may present such an alternative.

Free tissue transfer in head and neck reconstruction: 100 consecutive cases.

OBJECTIVES: Free flap reconstruction of head and neck defects is a rapidly changing field. We present a case series in this field in which we critically assess our survival rates and complications, and we highlight specific technical variables that may be associated with improved outcomes. METHODOLOGY: This case series from a tertiary medical centre comprises 100 consecutive head and neck microvascular free flap reconstructions. Medical notes were reviewed specifically for indications, adjuvant and neoadjuvant chemoradiotherapy, complications, and outcome of the free flap. RESULTS: The overall flap survival rate was 99%, with a 6% return-to-theatre rate. Three cases had a general complication in the form of a non-flap compromising haematoma that necessitated a return to theatre for an evacuation. Specific microvascular anastomosis-related complication rate was 2% requiring salvage revision. One flap was lost due to infection. Of the 100 cases, 87% were fasciocutaneous free flaps, 7% were musculocutaneous, 5% were osseocutaneous, and one was a skin/cartilage free flap. With regard to indications for reconstruction, oncological resection accounted for 86% of cases; a total of 12% had mandibular bone involvement that required osseocutaneous reconstruction. CONCLUSIONS: We have highlighted specific technical steps we used that may have contributed to our positive results. Moreover, we encourage the use of standardised postoperative monitoring guidelines for all multidisciplinary surgical teams involved in head and neck patients; they facilitate communication and increase early detection of complications, permitting timely intervention, which may be critical for flap survival.

Safety of major reconstructive surgery during the peak of the COVID-19 pandemic in the United Kingdom and Ireland - multicentre national cohort study.

BACKGROUND: The safety of surgery during and after the coronavirus disease-2019 (COVID-19) pandemic is paramount. Early reports of excessive perioperative mortality in COVID-positive patients promoted the widespread avoidance of operations. However, cancelling or delaying operations for cancer, trauma, or functional restitution has resulted in increased morbidity and mortality. METHODS: A national multicentre cohort study of all major reconstructive operations carried out over a 12-week period of the 'COVID-19 surge' in the United Kingdom and Ireland was performed. Primary outcome was 30-day mortality and secondary outcome measures were major complications (Clavien-Dindo grade ≥3) and COVID-19 status of patients and healthcare professionals before and after surgery. RESULTS: A total of 418 patients underwent major reconstructive surgery with a mean operating time of 7.5 hours and 12 days' inpatient stay. Cancer (59.8%) and trauma (29.4%) were the most common indications. COVID-19 infection was present in 4.5% of patients. The 30-day post-operative mortality was 0.2%, reflecting the death of one patient who was COVID-negative. Overall complication rate was 20.8%. COVID status did not correlate with major or minor complications. Eight healthcare professionals developed post-operative COVID-19 infection, seven of which occurred within the first three weeks. CONCLUSIONS: Major reconstructive operations performed during the COVID-19 crisis have been mostly urgent cases involving all surgical specialties. This cohort is a surrogate for all major operations across all surgical specialties. Patient safety and surgical outcomes have been the same as in the pre-COVID era. With adequate precautions, major reconstructive surgery is safe for patients and staff. This study helps counsel patients of COVID-19 risks in the perioperative period.

Insect salivary glands: stimulation of fluid secretion by 5-hydroxytryptamine and adenosine-3',5'-monophosphate.

Low concentrations (10(-9)M) of 5-hydroxytryptamine increase the rate of fluid secretion by isolated salivary glands of adult Calliphora. 5-Hydroxytry ptamine is present in Calliphora brain. Adenosine-3',5'-monophosphate (cyclic AMP) also stimulates fluid secretion and may be involved in the mode of action of 5-hydroxytryptamine.

Enzyme kinetic and molecular modelling studies of sulphur-containing substrates of phenylalanine 4-monooxygenase.

Previous investigations into the binding of substrates/cofactors to the PAH active site have only concentrated on Phe, thienylalanine and BH(4). This is the first reported investigation to model aliphatic thioether amino acid substrates to PAH. The clearance of the thioether substrates (4.82-79.09% of Phe) in the rat and human (1.19-37.41% of Phe) showed species differences. The xenobiotic thioether substrates (SMC and SCMC) were predicted to be poor substrates for PAH by the molecular modelling investigation and this has now been confirmed by the in vitro enzyme kinetic data. However, reaction phenotyping investigations have found that PAH was the major enzyme involved in the metabolism of SCMC in vitro and in vivo.

Photoperiodism in Ostrinia nubilalis: a new protocol for the analysis of the role of the circadian system.

A 12-hr dark period, at a temperature high enough to permit time measurement to occur, is necessary for maximal induction of larval diapause in the European corn borer, Ostrinia nubilalis. In the present study, induction of diapause only occurred in a periodic environment. This was in the form of certain (1) light-dark (LD) cycles at a constant temperature; (2) thermoperiods in constant darkness (DD), but not constant illumination (LL); and (3) LD cycles with concurrent thermoperiods. A light-break experiment protocol, in which the pulses systematically scan the cold and warm phases of a thermoperiod in DD, is discussed as a way of helping clarify how seasonal time measurement is effected in Ostrinia.

Insect photoperiodism: diversity of results in night-break experiments, including nonresponsiveness to light.

Three night-break experiment protocols were utilized in an attempt to help clarify the role of the circadian system in photoperiodic time measurement in the European corn borer, Ostrinia nubilalis. Larvae raised in a light-dark (LD) cycle consisting of 12 hr of light alternating with 12 hr of darkness (LD 12:12), at a constant temperature of 30 degrees C, enter a state of arrested growth and development known as diapause (Takeda and Skopik, 1985). In the present research (Experiment 1), the induction of diapause was prevented by 1-hr light pulses that systematically scanned the dark phase of LD 12:12. Thus, the importance of 12 hr of uninterrupted darkness for maximal induction of diapause is stressed. The same experimental protocol applied to larvae already in diapause (Experiment 2), however, resulted in a bimodal curve of diapause termination. Although this result is consistent with the proposition that a nonperiodic hourglass timer underlies this event (Skopik and Takeda, 1986), it does not rule out the circadian system. Like LD 12:12, a thermoperiod in constant darkness (12 hr at 4 degrees C alternating with 12 hr at 25 degrees C) also induces diapause. Scanning such a thermoperiod with 1-hr light pulses, however, resulted in only a small effect (reduction of diapause) when light fell in the early to middle part of the warm phase (Experiment 3). Thus, the time-measuring system, under these experimental conditions, showed only a weak response to light. This unexpected result is discussed with respect to Experiment 1 and two general models that have been proposed to account for photoperiodic time measurement in insects.

An evaluation of cold chain system for vaccines in Bangalore.

The cold chain plays a major role in the universal immunization programme which helps in preventing against six major killer diseases in children. We collected 144 study samples randomly from different parts of Bangalore to know the training status of personnel, refrigeration facilities, storage, monitoring and potency of vaccines. It was observed that 6.6% of general practitioners were trained under Universal Immunization Programme, monitoring was not satisfactory, and two of the OPV samples from medical practitioners had an unsatisfactory titre dose. Comprehensive orientation/training on cold chain is essential for medical practitioners and other professionals.

Is there any intersectoral coordination between health and education department at primary health center level?

One of the principles of primary health care is intersectoral co-ordination. A cross sectional study done at the primary health center revealed existence of unsatisfactory co-ordination between health and education department.

PIP: According to the 1991 census, more than half of India's population is illiterate. In this context, education can have an enormous effect upon health. Efforts need to be taken to incorporate the principles and practice of good health among school-goers at all levels. 106 teachers of mean age 40 years from 52 schools and 21 health staff of mean age 30 years from K. Gollahally, Primary Health Center area, Bangalore urban district, were interviewed to assess their health-related knowledge, attitudes, and practice. Although 70 (66%) teachers had heard of the Health for All by the Year 2000 slogan, only 32 could satisfactorily explain what the slogan means. 46% of teachers and 50% of health staff were aware of intersectoral coordination (ISC). All teachers and 90% of health staff favor ISC and believe that education improves health and that health improves education. All teachers endorse cleanliness at school, general personal hygiene, and the provision of recreational facilities, but only 45% had been taught about such topics. 50% of teachers could satisfactorily explain why children should be immunized, and the majority of teachers believe that a nutritious diet is needed to promote health or for specific protection or both. Teachers were poorly informed regarding health and although the study participants were aware of the need for ISC, they did not regularly attend primary health care/school meetings.

Ionising radiation exposure in paediatric trauma.

INTRODUCTION: Trauma remains the highest cause of paediatric morbidity and mortality. These trauma patients incur radiation exposure during intraoperative management. Medical personnel have the responsibility to ensure observation of the 'as low as reasonably achievable' principle, a practice mandate that minimises ionising radiation exposure. The aim of this study was to quantify the difference in the amount of ionising radiation used by operating surgeons of different grades in paediatric trauma surgery. METHODS: Intraoperative imaging in paediatric trauma surgery between 2008 and 2010 at a UK trauma centre was analysed retrospectively, recording injury demographics, surgeon grade, radiation exposure (dose area product [DAP]) and screening time. A mobile image intensifier was used in all cases and the lowest dose rate was selected for all screening. RESULTS: A total of 782 trauma cases were analysed: 304 procedures (39%) were carried out by consultants, 127 (16%) by senior registrars and 351 (45%) by junior registrars. The mean screening time for consultants was 0.23 minutes (standard deviation [SD]: 0.21 minutes) while for senior registrars it was 0.24 minutes (SD: 0.27 minutes) and for junior registrars 0.47 minutes (SD: 1.5 minutes). The mean DAP for consultants was 58.49Gycm(2) (SD: 53.66Gycm(2)). For senior registrars it was 87.2Gycm(2) (SD: 126.64Gycm(2)) and for junior registrars it was 90.46Gycm(2) (SD: 180.02Gycm(2)). This equates to a 51% increase in screening time and a 35% increase in DAP by a junior registrar compared with a consultant. CONCLUSIONS: Significantly lower screening times and radiation exposure was found in procedures performed by consultants compared with registrars (p<0.001). Given the harmful and unknown long-term effects of ionising radiation exposure in children, we recommend increasing consultant presence in paediatric trauma theatres.

Development and in vivo evaluation of silver sulfadiazine loaded hydrogel consisting polyvinyl alcohol and chitosan for severe burns.

A new Hydrogel containing silver Sulfadiazine (SSD) was developed for enhanced burns wound healing. The hydrogel was prepared by cross-linking of PVA and Chitosan by freeze thawing method. Their gel properties, moisture retaining capacity, fluid uptake capacity, in vitro release study, in vivo burn healing effect were evaluated. Chitosan and PVA cross linking decreased gel fraction upto 70% determined the good gel properties. This cross linked hydrogel increased the Swelling ratio and Water vapour transmission rate (WVTR) which provides the sustained release of drug and moist environment for healing respectively. The hydrogel containing 7.5% of PVA, 0.75% of chitosan found to have increased gel strength, higher water vapour transmission rate and fluid uptake capacity suitable for faster healing of burns. This hydrogel also sustained the release of 1% SSD required for longer antimicrobial activity and found better in vivo burn healing capacity as compared to marketed preparation. Thus hydrogel containing 7.5% of PVA, 0.75% of chitosan and 1% SSD is a potential burns dressing with better gel properties and excellent burns healing capacity.

An in vivo evaluation of a chondroitin sulfate solution to prevent postoperative intraperitoneal adhesion formation.

PURPOSE: The goal of this study was to determine the efficacy of a single intraperitoneal administration of a chondroitin sulfate solution in preventing postoperative adhesion formation. METHODS. Twenty-five Sprague-Dawley rats had a 1-cm(2) area of cecal serosa abraded. Controls (CON, n = 5) received no treatment, the chondroitin sulfate group (CS, n = 10) received chondroitin sulfate (0.013 g/kg) in 0.9% NaCl intraperitoneally (ip), and vehicle controls (VC, n = 10) received an equal volume of 0.9% NaCl solution ip before the abdomen was closed. All animals were sacrificed on postoperative day 10. The extent of adhesion was quantified according to Mazuji's adhesion grade (0 to 4: 0 = no adhesion and 4 = very dense adhesion) and quantitated after H&E, trichome, and immunohistochemical staining for fibrin and collagen type I and type III using digital image analysis. RESULTS: The mean Mazuji's adhesion grade in the CON was 4.0 +/- 0.0, in the VC 2.60 +/- 0.37, and in the CS 1.3 +/- 0.42 (P < 0.01 for CS vs CON and P < 0.05 for CS vs VC comparisons). The mean gray-scale intensity (0-255: 0 = dense amount and 255 = none) of adhesion density in the CON was 105. 5 +/- 5.5, in the VC 125 +/- 15.0, and in the CS 178.3 +/- 21.0 (P < 0.01 for CS vs CON and P < 0.05 for CS vs VC comparisons). The mean adjusted intensity stain indices (AISI) for fibrin and collagen type I in the CON were 59 +/- 17 and 53 +/- 19, in the VC 27 +/- 3 and 25 +/- 7, and in the CS 16 +/- 5 and 6 +/- 3, respectively (P < 0.05 between CS and CON comparisons). The AISI of collagen type III was not significant among all the groups (P > 0.1). CONCLUSIONS: The extent of early postoperative intra-abdominal adhesion formation as determined by gross assessment and from quantitation of fibrin and collagen type I deposition was significantly reduced by a single intraperitoneal administration of a chondroitin sulfate solution.