Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.Aims
Methods
Tranexamic acid (TXA) has been shown to reduce post-operative blood loss, but the dosage and method of administration remains controversial. The purpose of our study was to study the effectiveness of topical TXA in a cohort of patients (n=224) undergoing TKA by a single surgeon. Two groups of patients who received topical TXA were compared to patients who did not receive TXA. Patients that received topical TXA had the least early postoperative blood loss, with patients that received topical TXA with a tourniquet and a drain having the least. Patients receiving TXA required fewer transfusions than patients who did not receive TXA and there was no difference in the rate of symptomatic DVT/PE. Our results support the use of topical TXA during TKA.
Little guidance exists in the current literature regarding which patient recorded outcome measures (PROMs) are most clinically appropriate following anterior cruciate ligament reconstruction (ACL) surgery, and what results surgeons should expect or accept. Many PROMs have been validated, but their “ideal” results have not been published, limiting a surgeon's ability to compare their patients’ outcomes with those of their colleagues. We undertook a systematic review of PROMs for ACL to look at common usage and outcomes. After appropriate paper selection, we then undertook a
Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery. The NO PAin trial is a
Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery. The NO PAin trial is a
Abstract. Background. Distal third clavicle (DTC) fractures represent 2.6 to 4% of all adult fractures but there is no consensus as to the surgical management of these injuries. The primary outcomes of this study were to determine the frequency of DTC fractures and their management. Secondary outcomes included complications, further procedures, fracture union and the breakdown of treatment by modified Neer classification. Methods. A multicentre cohort study was conducted between 1. st. January 2019–31. st. December 2019. All patients, over 18 years old, with an isolated DTC fracture were included. Demographic variables, management, mechanism of injury, modified Neer classification and fracture union were recorded. Simple statistical analysis was performed as a total dataset and as a breakdown of major trauma centres (MTCs) vs trauma units (TUs). Results. 859 patients from 18 different NHS trusts (15 TUs and 3 MTCs) were included. The mean age was 57 years (18 to 99). 87% were treated conservatively and 54% were Neer type 1 fractures. With regards to operative management, 89% of patients who underwent an operation were under the age of 60. 56% of patients had evidence of union at most recent follow-up. Conclusions. This is the first and largest epidemiological review of DTC fractures in the UK. Results show that younger patients, suffering higher mechanism of injury, are more likely to undergo surgery. Furthermore, rates of union are low but further research is needed to determine the functional outcomes of these patients. There is scope for a
Aims. The ongoing COVID-19 pandemic has disrupted and delayed medical and surgical examinations where attendance is required in person. Our article aims to outline the validity of online assessment, the range of benefits to both candidate and assessor, and the challenges to its implementation. In addition, we propose
Background. In the United Kingdom, over 1 million elective surgeries were cancelled due to COVID-19, resulting in over 1.9 million people now waiting more than 4 months for their procedure – 3x the number last year. To address this backlog, the healthcare service has been asked to develop locally-designed ‘COVID-light’ facilities. In our local system, 822 patients awaited orthopaedic surgery when elective surgery was permitted to resume. The phased return of service required a careful and
Tranexamic acid (TXA) is an effective medication to limit blood loss and transfusion requirements in association with contemporary total joint arthroplasty. TXA is in a class of medications termed anti-fibrinolytics due to their action to limit the breakdown of clot that has already been formed. It is useful to note that TXA does not promote the formation of clot, it simply limits the breakdown of already established clot. A recent systematic review and meta-analysis of randomised clinical trials of TXA use in total hip replacement demonstrated: 1) a substantial reduction in the proportion of patients who required transfusion and 2) no increase in DVT or PE. Similarly a recent Cochrane Database systematic review assessed Anti-fibrinolytic Use for Minimizing Perioperative Blood Transfusion and found tranexamic acid to be effective in reducing blood loss during and after surgery and to be free of serious adverse effects. In orthopaedic surgery varying doses have been used over time. A
The entirety of the patient experience after contemporary total knee and total hip replacements in 2017 is markedly different from that encountered by patients just a decade ago. Ten years ago most patients were treated in a traditional sick-patient model of care and because they were assumed to require substantial hospital intervention, many cumbersome and costly interventions (e.g. indwelling urinary catheters, patient-controlled-analgesic pumps, autologous blood transfusion, continuous passive motion machines) were a routine part of the early post-operative experience. Today the paradigm has shifted to a well-patient model with a working assumption that once a patient has been medically optimised for surgery then the intervention itself, hip or knee replacement, will not typically create a sick-patient. Instead it is expected that most patients can be treated safely and more effectively with less intensive hospital intervention. While as orthopaedic surgeons we are enamored with the latest surgical techniques or interesting technologies most busy surgeons recognise that advances in peri-operative pain management, blood management, and early-mobilization therapy protocols account for the greatest share of improvements in patient experience over the past decade. One can think
Blood conservation is an essential aspect of total hip arthroplasty (THA). As recently as 10 years ago, it was standard practice across North America for patients to undergo pre-operative autologous blood donation (PAD) prior to an elective TJA. Though the cost of PAD is about the same as allogenic blood transfusion, it has fallen out of favor due to mixed results. Instead, most surgeons have implemented a practice of obtaining pre-operative hemoglobin levels. If anemia is diagnosed, the patient should be worked up for the underlying cause. In cases of pre-operative anemia where a specific deficiency cannot be elucidated, consideration can be given to the use of erythropoietin (EPO). The routine use of tranexamic acid (TXA) has become the standard of care at most institutions since it is safe, inexpensive, easy to administer, and very effective at minimizing peri-operative blood transfusion. Intravenous TXA can be administered effectively in a variety of different ways and a number of different protocols are described. The popularised Mayo Clinic protocol is to administer TXA once prior to incision (1g IV in 50mL of normal saline) and once during wound closure. Acute normovolemic hemodilution is a technique utilised just before or after the induction of anesthesia in which whole blood is removed while keeping the patient normovolemic with acellular fluids (i.e. crystalloids or colloids). This technique is rarely used. Hypotensive anesthesia is a technique utilised to keep mean arterial pressures (MAP) at a level around 50mm Hg. It appears to be most effective with the use of epidural anesthesia. Certain patients may not be good candidates for hypotensive anesthesia (high cardiac risk factors), but it can be an effective corollary to other intra-operative measures. Historically, many surgeons practiced reflexive transfusion protocols rather than treating patients on an individual basis. Current practice has adopted a more
Tranexamic acid (TXA) is an effective medication to limit blood loss and transfusion requirements in association with contemporary total joint arthroplasty. TXA is in a class of medications termed anti-fibrinolytics due to their action to limit the breakdown of a clot that has already been formed. It is useful to note that TXA does not promote the formation of a clot, it simply limits the breakdown of already established clots. A recent systematic review and meta-analysis of randomised clinical trials of TXA use in total hip replacement demonstrated: 1) a substantial reduction in the proportion of patients who required transfusion and 2) no increase in DVT or PE. Similarly a recent Cochrane Database systematic review assessed Anti-fibrinolytic Use for Minimizing Perioperative Blood Transfusion and found tranexamic acid to be effective in reducing blood loss during and after surgery and to be free of serious adverse effects. In orthopaedic surgery, varying doses have been used over time. A
The entirety of the patient experience after contemporary total knee and total hip replacements in 2016 is markedly different from that encountered by patients just a decade ago. Ten years ago most patients were treated in a traditional sick-patient model of care and because they were assumed to require substantial hospital intervention, many cumbersome and costly interventions (e.g. indwelling urinary catheters, patient-controlled-analgesic pumps, autologous blood transfusion, continuous passive motion machines) were a routine part of the early post-operative experience. Today the paradigm has shifted to a well-patient model with a working assumption that once a patient has been medically optimised for surgery then the intervention itself, hip or knee replacement, will not typically create a sick-patient. Instead it is expected that most patients can be treated safely and more effectively with less intensive hospital intervention. While as orthopaedic surgeons we are enamored with the latest surgical techniques or interesting technologies most busy surgeons recognise that advances in peri-operative pain management, blood management, and early-mobilisation therapy protocols account for the greatest share of improvements in patient experience over the past decade. One can think
The entirety of the patient experience after contemporary total knee and total hip replacements in 2016 is markedly different from that encountered by patients just a decade ago. Ten years ago most patients were treated in a traditional sick-patient model of care and because they were assumed to require substantial hospital intervention, many cumbersome and costly interventions (e.g. indwelling urinary catheters, patient-controlled-analgesic pumps, autologous blood transfusion, continuous passive motion machines) were a routine part of the early post-operative experience. Today the paradigm has shifted to a well-patient model with a working assumption that once a patient has been medically optimised for surgery then the intervention itself, hip or knee replacement, will not typically create a sick-patient. Instead it is expected that most patients can be treated safely and more effectively with less intensive hospital intervention. While as orthopaedic surgeons we are enamored with the latest surgical techniques or interesting technologies most busy surgeons recognise that advances in peri-operative pain management, blood management, and early-mobilization therapy protocols account for the greatest share of improvements in patient experience over the past decade. One can think
Introduction. Intra-articular (IA) injections of corticosteroids and hyaluronic acid (HA) products are used to treat patients with knee osteoarthritis pain that has not responded to more conservative treatment. Corticosteroids are a standard of care despite only suggestive clinical evidence of 12 or more weeks of pain relief. However the duration of pain relief with this treatment appears to be short and not a long term solution. Methods. A double-blinded, randomised, active controlled, multicentre non-inferiority trial with 442 subjects provided a
Tranexamic acid (TXA) is an effective medication to limit blood loss and transfusion requirements in association with contemporary total joint arthroplasty. TXA is in a class of medications termed anti-fibrinolytics due to their action to limit the breakdown of clot that has already been formed. It is useful to note that TXA does not promote the formation of clot, it simply limits the breakdown of already established clot. A recent systematic review and meta-analysis of randomised clinical trials of TXA use in total hip replacement demonstrated: 1) a substantial reduction in the proportion of patients who required transfusion and 2) no increase in DVT or PE. Similarly a recent Cochrane Database systematic review assessed Anti-fibrinolytic Use for Minimising Perioperative Blood Transfusion and found tranexamic acid to be effective in reducing blood loss during and after surgery and to be free of serious adverse effects. The typical dose of TXA in cardiac surgery has been 10–20 mg/kg as an IV bolus given over 10–20 minutes followed by continuous infusion of 1 mg/kg/hour for 8 hours. In orthopaedic surgery varying doses have been used over time. A
Crescent fractures are represented by a spectrum of morphological fracture patterns, sharing a common mechanism of injury. We propose three distinct types according to the extent of Sacroiliac (SI) joint involvement and the size of the crescent fragment, which enables a
There is an increasing prevalence of haptic devices in many engineering fields, especially in medicine and specifically in surgery. The stereotactic haptic boundaries used in Computer Aided Orthopaedic Surgery Unicomparmental Knee Arthroplasty (CAOS UKA) systems for assistive milling control can lead to an increase in the force required to manipulate the device; this study presented here has seen a several fold increase in peak forces between haptic and non-haptic conditions of a semi-active preoperative image system. Orthopaedic Arthroplasty surgeons are required to apply forces ranging from large gripping forces to small forces for delicate manipulation of tools and through a large range of postures. There is also a need for surgeons to move around and position themselves to gain line of sight with the object of interest and to operate while wearing additional clothing such as the protective headwear and double gloves. These factors further complicate comparison with other ergonomic studies of other robotics systems. While robotics has been implemented to reduce fatigue in surgery one area of concern in CAOS is localised user muscle fatigue in high volume use. In order to create the conditions necessary for the generation of fatigue in a realistic user experience, but in the time available for the participants, an extended period of controlled and prolonged cutting and manipulation of the robotic arm was needed. This
COVID-19 has compounded a growing waiting list problem, with over 4.5 million patients now waiting for planned elective care in the UK. Views of patients on waiting lists are rarely considered in prioritization. Our primary aim was to understand how to support patients on waiting lists by hearing their experiences, concerns, and expectations. The secondary aim was to capture objective change in disability and coping mechanisms. A minimum representative sample of 824 patients was required for quantitative analysis to provide a 3% margin of error. Sampling was stratified by body region (upper/lower limb, spine) and duration on the waiting list. Questionnaires were sent to a random sample of elective orthopaedic waiting list patients with their planned intervention paused due to COVID-19. Analyzed parameters included baseline health, change in physical/mental health status, challenges and coping strategies, preferences/concerns regarding treatment, and objective quality of life (EuroQol five-dimension questionnaire (EQ-5D), Generalized Anxiety Disorder 2-item scale (GAD-2)). Qualitative analysis was performed via the Normalization Process Theory.Aims
Methods
This Outcome Studies Software suite has been designed and carried out by Surgeons for Surgeons in order to provide the Orthopaedic Community with a valuable tool devoted to the computerized clinical follow-up of Joint Arthroplasty, named OrthoWave(tm). The development of the OrthoWave(tm) suite, since 1996, has got involved clinical studies coordinators, software engineers, orthopaedic surgeons, and statisticians. One underlying theme regarding Health Care has and always will be constant: the need to understand if our treatments actually work. Providing answers makes not only scientific sense but
