A blind, placebo–controlled clinical trial was performed to evaluate the postoperative analgesic effect of topically administered, intraoperative, epidural morphine (Duramorph™) and intramuscular infiltration of the incision site with bupivacaine prior to closure of the skin in dogs undergoing hemilaminectomy for Hansen type I Intervertebral Disk Disease (IVDD). Thirty-three dogs were randomly allocated into four treatment groups: epidural Duramorph™ with incisional bupivacaine (DUR/BUP), epidural saline with incisional bupivacaine (SAL/BUP), epidural Duramorph™ with incisional saline (DUR/SAL), and epidural saline with incisional saline (SAL/SAL). All dogs were premedicated with a standard protocol and were anesthetized with propofol and isoflurane. After surgery, scores were assigned using a visual analog scale (VAS) for both pain and sedation and a composite pain scale (CPS). In addition, a von Frey anesthesiometer was used to determine pain thresholds at 1 cm and 3 cm from the surgical incision line (primary hyperalgesia) as well as on the lateral aspect of the stifle (secondary hyperalgesia). Assessments were carried out at fixed intervals over the 48 hour postoperative period. Significant differences were found between those groups treated with the epidural Duramorph™ and those that received epidural saline. Those dogs in the DUR/BUP and DUR/SAL groups exhibited lower von Frey pain thresholds and higher VAS and CPS scores than the SAL/BUP and SAL/SAL groups. The administration of bupivacaine had no significant effect on any measured outcome. The authors conclude that topically administered epidural Duramorph™ and intramuscular incisional bupivacaine do not enhance analgesia following hemilaminectomy in the dog. / Master of Science

In collaboration with the Karolinska University Hospital, this research was carried out with the aim of executing a consequence analysis of the new regulation (EU) 2017/746. The consequences of the regulation regarding access, distribution, manufacturing and in-house production of in vitro diagnostic products were examined for various departments at the Karolinska University Hospital. This was investigated through an extensive literature study and interviews that were conducted digitally and through email. Of the departments examined, attention was drawn to the fact that only Lab & Primary Health Care and the Karolinska University Laboratory were affected by the new regulation. The availability of products may be affected as a consequence of the new requirements for risk classification and the notified bodies. If the manufacturer does not meet the new requirements, this may lead to a shortage of materials and products, which can affect Lab & Primary Care and the Karolinska University Laboratory. Lab & Primary Health Care will be affected by the requirements for distribution in the new regulation if they decide to distribute new in vitro diagnostic products to other businesses. The Karolinska University Laboratory has a production that they currently CE mark according to the old directive and an in-house production. In order for the Karolinska University Laboratory to continue its own production, it is required that they meet the requirements imposed on in-house production in the new regulation. With continued CE marking of the products, they will be classified as manufacturers and need to meet its requirements. In summary, it can be stated that both Lab & Primary Health Care and the Karolinska University Laboratory have three paths to go; distribute, produce in-house or manufacture in vitro diagnostic products. Depending on the decision they make, they are classified differently according to the new regulation (distributors, in-house manufacturers or manufacturers) and thus have different requirements to follow. / I samarbete med Karolinska Universitetssjukhuset utfördes denna studie med målet att genomföra en konsekvensanalys av det nya regelverket (EU) 2017/746. Regelverkets konsekvenser gällande tillgång, distribution, tillverkning och egentillverkning av in vitro-diagnostik produkter undersöktes för olika enheter inom Karolinska Universitetssjukhuset. Detta undersöktes genom en omfattande litteraturstudie och intervjuer som utfördes digitalt och via mail. Av de enheter som granskades uppmärksammades att endast Lab & Primärvård och Karolinska Universitetslaboratoriet påverkades av den nya lagstiftningen. Tillgången på produkter kan komma att påverkas som en konsekvens av de nya kraven på riskklassificering och på de anmälda organen. Om tillverkaren inte uppfyller de nya kraven kan detta leda til brist på material och produkter, vilken kan påverka Lab & Primärvård samt Karolinska Universitetslaboratoriet. Lab & Primärvård kommer beröras av kraven för distribution i den nya förordningen om de beslutar att distribuera nya in vitro-diagnostik produkter till andra verksamheter. Karolinska Universitetslaboratoriet har en tillverkning som de i dagsläget CE-märker enligt det gamla direktivet samt en egentillverkning. För att Karolinska Universitetslaboratoriet ska fortsätta sin egentillverkning krävs det att de uppfyller kraven som ställs på egentillverkare i nya regelverket. Vid fortsatt CE-märkning av produkterna kommer de att klassas som tillverkare och behöver uppfylla dess krav. Sammanfattningsvis kan det konstateras att både Lab & Primärvård och Karolinska Universitetslaboratoriet har tre vägar att gå; distribuera, egentillverka eller tillverka in vitro-diagnostik produkter. Beroende på beslutet de fattar klassas de olika enligt det nya regelverket (distributörer, egentillverkare eller tillverkare) och har därmed olika krav att följa.

abstract: Intervertebral Disc Degeneration (IVDD) is a complex phenomenon characterizing the desiccation and structural compromise of the primary joint in the human spine. The intervertebral disc (IVD) serves to connect vertebral bodies, cushion shock, and allow for flexion and extension of the vertebral column. Often presenting in the 4th or 5th decades of life as low back pain, this disease was originally believed to be the result of natural “wear and tear” coupled with repetitive mechanical insult, and as such most studies focus on patients between 40 and 50 years of age. Research over the past two decades, however, has demonstrated that environmental factors have only a modest effect on disc degeneration, with genetic influences playing a much more substantial role. Extensive research has focused on this process, though definitive risk factors and a clear pathophysiology have proven elusive. The aim of this study was to assemble a cohort of patients exhibiting definitive signs of degeneration who were well below the average age of presentation, with minimal or no exposure to suspected environmental risk factors and to conduct a targeted genome analysis in an attempt to elucidate a common genetic component. Through whole genome sequencing and analysis, the results corroborated findings in a previous study, as well as demonstrated a potential connection and influence between mutations found in IVD structural or functional genes, and the provocation of IVDD. Though the sample size was limited in scale and age, these findings suggest that further IVDD research into the association of variants in collagen, aggrecan and the insulin-like growth factor receptor genes of young patients with an early presentation of disc degeneration and minimal exposure to suspected risk factors is merited. / Dissertation/Thesis / Masters Thesis Biology 2016

The objective of this prospective pilot study is to assess the feasibility of a minimally invasive, integrated endoscopic hemilaminectomy in chondrodystrophic dogs with clinically relevant Hansen type 1 intervertebral disc extrusion (IVDE). Study subjects included five client-owned chondrodystrophic dogs under 15kg with an acute, single site IVDE between T10 and L5 of less than 90 days duration and no loss of deep pain perception. The extent of the extrusion could not exceed 2/3 the diameter of the cannula to be used as defined by magnetic resonance imaging (MRI). A postoperative MRI was performed to assess remaining spinal cord compression. If significant compression remained, patients returned to surgery for a standard, open hemilaminectomy. Only the first dog required conversion to an open approach which resulted in adequate decompression. The same dog had a significant surgical complication of iatrogenic damage to the spinal cord during the minimally invasive approach. The other 4 dogs had no complications and achieved adequate spinal cord decompression. Three dogs eventually returned to normal neurologic status and another was improved compared to presentation. One dog was euthanized for reasons unrelated to IVDE. The authors conclude that a minimally invasive, integrated endoscopic hemilaminectomy is a feasible approach and can allow for adequate decompression of the spinal cord secondary to acute, single-site extrusion. Endoscopic approaches have a steep learning curve and extra care is required in the learning phase to avoid complications. Further studies are warranted to compare the safety and efficacy of this technique to a standard approach. / Master of Science / Acute intervertebral disc extrusion, or "slipped disc", is a common spinal emergency in dogs, particularly in small, chondrodystrophic breeds like dachshunds. Surgery is aimed at removing the disc material causing spinal cord compression. The traditional approach, known as a hemilaminectomy, involves elevating the muscles along the spine over multiple vertebrae, followed by creating a window in the bone with a surgical burr. Minimally invasive spinal surgery that minimizes the elevation of muscles, has the potential to decrease postoperative pain, surgical time, hospital stay, intraoperative blood loss and recovery time. This study was designed to assess the use of a minimally invasive, integrated endoscopic approach to a hemilaminectomy in clinical patients. Five dogs were enrolled with an acute, single site intervertebral disc extrusion between T10 and L5 that was no more than 2/3 the diameter of the cannula to be used in surgery. Study subjects were chondrodystrophic breeds under 15kg. All dogs had intact deep pain perception. Spinal cord compression was assessed by magnetic resonance imaging (MRI) both before and after a minimally invasive approach. If significant acute compression remained, a standard, open approach was immediately performed. Spinal cord decompression was adequate in all but one dog which required a second procedure to remove the remaining material. This same dog had accidental damage to the spinal cord during the minimally invasive approach. Three dogs eventually returned to normal neurologic status and the dog that required a second, traditional approach surgery eventually improved compared to his preoperative status. One dog was improving but euthanized eight days later due to chronic disease unrelated to IVDE. This approach is feasible for decompressing the spinal cord after a single site, acute intervertebral disc extrusion in a chondrodystrophic dog. However, like any endoscopic surgery, previous experience is of great benefit and errors are more likely to happen during the learning phase.