Randomized Clinical Trials and Observational Tribulations: Providing Clinical Evidence for Personalized Surgical Pain Management Care Models

Proving clinical superiority of personalized care models in interventional and surgical pain management is challenging. The apparent difficulties may arise from the inability to standardize complex surgical procedures that often involve multiple steps. Ensuring the surgery is performed the same way every time is nearly impossible. Confounding factors, such as the variability of the patient population and selection bias regarding comorbidities and anatomical variations are also difficult to control for. Small sample sizes in study groups comparing iterations of a surgical protocol may amplify bias. It is essentially impossible to conceal the surgical treatment from the surgeon and the operating team. Restrictive inclusion and exclusion criteria may distort the study population to no longer reflect patients seen in daily practice. Hindsight bias is introduced by the inability to effectively blind patient group allocation, which affects clinical result interpretation, particularly if the outcome is already known to the investigators when the outcome analysis is performed (often a long time after the intervention). Randomization is equally problematic, as many patients want to avoid being randomly assigned to a study group, particularly if they perceive their surgeon to be unsure of which treatment will likely render the best clinical outcome for them. Ethical concerns may also exist if the study involves additional and unnecessary risks. Lastly, surgical trials are costly, especially if the tested interventions are complex and require long-term follow-up to assess their benefit. Traditional clinical testing of personalized surgical pain management treatments may be more challenging because individualized solutions tailored to each patient’s pain generator can vary extensively. However, high-grade evidence is needed to prompt a protocol change and break with traditional image-based criteria for treatment. In this article, the authors review issues in surgical trials and offer practical solutions

The Changing Environment in Postgraduate Education in Orthopedic Surgery and Neurosurgery and Its Impact on Technology-Driven Targeted Interventional and Surgical Pain Management : Perspectives from Europe, Latin America, Asia, and The United States

Personalized care models are dominating modern medicine. These models are rooted in teaching future physicians the skill set to keep up with innovation. In orthopedic surgery and neurosurgery, education is increasingly influenced by augmented reality, simulation, navigation, robotics, and in some cases, artificial intelligence. The postpandemic learning environment has also changed, emphasizing online learning and skill- and competency-based teaching models incorporating clinical and bench-top research. Attempts to improve work–life balance and minimize physician burnout have led to work-hour restrictions in postgraduate training programs. These restrictions have made it particularly challenging for orthopedic and neurosurgery residents to acquire the knowledge and skill set to meet the requirements for certification. The fast-paced flow of information and the rapid implementation of innovation require higher efficiencies in the modern postgraduate training environment. However, what is taught typically lags several years behind. Examples include minimally invasive tissue-sparing techniques through tubular small-bladed retractor systems, robotic and navigation, endoscopic, patient-specific implants made possible by advances in imaging technology and 3D printing, and regenerative strategies. Currently, the traditional roles of mentee and mentor are being redefined. The future orthopedic surgeons and neurosurgeons involved in personalized surgical pain management will need to be versed in several disciplines ranging from bioengineering, basic research, computer, social and health sciences, clinical study, trial design, public health policy development, and economic accountability. Solutions to the fast-paced innovation cycle in orthopedic surgery and neurosurgery include adaptive learning skills to seize opportunities for innovation with execution and implementation by facilitating translational research and clinical program development across traditional boundaries between clinical and nonclinical specialties. Preparing the future generation of surgeons to have the aptitude to keep up with the rapid technological advances is challenging for postgraduate residency programs and accreditation agencies. However, implementing clinical protocol change when the entrepreneur–investigator surgeon substantiates it with high-grade clinical evidence is at the heart of personalized surgical pain management

The Geriatric Driver

The increase in the growth of the elderly population in the past 2 decades has been paralleled by an increase in the number of active elderly drivers. Consequentially, this growth has been accompanied by a rise in fatal road-related accidents. Due to age-related fragility, elderly drivers are more susceptible to injuries and death following a road-related accident. The increased risk of accidents has become a growing public health issue and has led to certain guidelines and restrictions for elderly drivers. Moreover, the cognitive and physiological decline that exacerbates with age has encouraged preventative measures aimed at optimizing their ability to operate motor vehicles. Some of these include yearly vision, cognitive, motor, and mental assessment tests. Results obtained from these tests may help suggest when an elderly driver becomes unsuitable to drive

Utility of Arthroscopic Surgery for Osteoarthritis of the Knee

Currently, there is no consensus as to which patients would benefit most from arthroscopic surgery of the knee. Recently published randomized trials have shown limited efficacy for arthroscopic debridement and partial meniscectomy in patients with knee osteoarthritis. However, these clinical trials and others are limited by methodological problems. Indeed, many surgeons believe that arthroscopic surgery is indicated in a select group of patients, namely those with mild osteoarthritis and associated meniscal injury. More level I evidence will be required to better define the role of arthroscopic surgery in patients with osteoarthritis of the knee

A critical role for erythropoietin on vagus nerve Schwann cells in intestinal motility

Abstract Background Dysmotility and postoperative ileus (POI) are frequent major clinical problems post-abdominal surgery. Erythropoietin (EPO) is a multifunctional tissue-protective cytokine that promotes recovery of the intestine in various injury models. While EPO receptors (EPOR) are present in vagal Schwann cells, the role of EPOR in POI recovery is unknown because of the lack of EPOR antagonists or Schwann-cell specific EPOR knockout animals. This study was designed to explore the effect of EPO via EPOR in vagal nerve Schwann cells in a mouse model of POI. Results The structural features of EPOR and its activation by EPO-mediated dimerization were understood using structural analysis. Later, using the Cre-loxP system, we developed a myelin protein zero (Mpz) promoter-driven knockout mouse model of Schwann cell EPOR (MpzCre-EPORflox/flox / Mpz-EPOR-KO) confirmed using PCR and qRT-PCR techniques. We then measured the intestinal transit time (ITT) at baseline and after induction of POI with and without EPO treatment. Although we have previously shown that EPO accelerates functional recovery in POI in wild type mice, EPO treatment did not improve functional recovery of ITT in POI of Mpz-EPOR-KO mice. Conclusions To the best of our knowledge, this is the first pre-clinical study to demonstrate a novel mouse model of EPOR specific knock out on Schwan cells with an effect in the gut. We also showed novel beneficial effects of EPO through vagus nerve Schwann cell-EPOR in intestinal dysmotility. Our findings suggest that EPO-EPOR signaling in the vagus nerve after POI is important for the functional recovery of ITT

Rotator Cuff Tears in the Elderly Patients

Rotator cuff tears (RCT) are a common clinical problem in the geriatric population, and debate exists over how to best provide pain relief and restore shoulder function. Treatment options can be broadly divided into nonsurgical and surgical, with the majority of patients initially placed on a trial of conservative therapy. For those with irreparable RCT, low functional demand, or interest in nonoperative management, there are a number of nonsurgical treatments to consider, including rehabilitation and injections of corticosteroids, hyaluronate, and platelet-rich plasma. Surgical treatment is increasingly common, as geriatric patients remain active with high functional demands. Studies in elderly populations have demonstrated satisfactory healing and clinical results following surgical repair. Predictors of poor outcome after repair are large tear size as well as higher stages of fatty infiltration. Decompression is a less invasive surgical option that has been shown to provide short-term pain relief, though the lasting effects may deteriorate over time. A number of factors must be weighed when considering which patients are likely to benefit from surgical intervention

Timing of Hip Fracture Surgery in the Elderly

The effect of preoperative wait time for surgery is a long-standing subject of debate. Although there is disagreement among clinicians on whether early surgery confers a survival benefit per se, most reports agree that early surgery improves other outcomes such as length of stay, the incidence of pressure sores, and return to independent living. Therefore, it would seem prudent to surgically treat elderly patients with hip fractures within the first 48 hours of admission. However, the current body of evidence is observational in nature and carries the potential for bias inherent in such analyses. Evidence in the form of a large randomized controlled trial may ultimately be required to fully evaluate the impact of surgical timing on patients with fractures of the hip

External Fixation Versus Open Reduction With Locked Volar Plating for Geriatric Distal Radius Fractures

The optimal management of displaced dorsal radius fractures (DRFs) in older patients remains an issue of debate. Bridging external fixation is a well-accepted treatment modality for severely comminuted DRFs, while open reduction and internal fixation with locked volar plating has emerged as a promising alternative in recent years. The current body of randomized trials supports the trend toward locked volar plating, as it allows for quicker improvement in subjective and functional outcomes. There is no clear evidence to suggest that one technique carries significantly less complications than the other. Locked volar plating should be considered in patients for whom an accelerated functional recovery would be advantageous. Otherwise, both external fixation and locked volar plating provide good long-term clinical outcomes

Initial Preoperative Management of Geriatric Hip Fractures

Hip fractures are a common emergency among the geriatric population and often requires immediate hospitalization for proper assessment. More than 90% of the time, hip fractures are suffered by individuals older than 65 and are usually precipitated predominantly by falls. Current studies show that the average individual over 65 years falls at least once a year, and roughly 1 out of every 4 of these individuals succumb to their injuries just 12 months following surgical treatment. Moreover, timely treatment and management of these hip fractures have shown to decrease mortality by reducing cardiopulmonary and venous thromboembolic complications that often accompany hip surgeries. As a result, an emphasis on initial preoperative assessment is important to help identify the presence of ancillary factors such as preexisting comorbidities, which can impact the course of treatment. Delaying surgical management of hip fractures has been linked to decreased functional outcomes and increased mortality rates. Time, rather than technique, appears to be a recurring factor that can impact the long-term survival of these patients. The initial preoperative assessment, therefore, presents a window of opportunity where possible interventions can be made in an effort to reduce the delay of surgery, minimize postsurgical complications, and ultimately improve mortality rate among patients with hip fracture