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BACKGROUND: Understanding how patients perceive and prioritise various aspects of recovery following total knee replacement, including pain, function and return to activity, will help clinicians in pre-operative consultations by ensuring they effectively address patient concerns and managing their expectations. AIMS: The aim of this study is to identify aspects of recovery that are important to people after a total knee replacement. METHODS: Studies were identified from Medline, Embase, PsycInfo, Cochrane Library and Web of Science. This mixed methods review included all original study types (quantitative, qualitative, discrete choice experiments and mixed methods design). Reviews and non-peer-reviewed publications were excluded. Studies with participants (age ≥ 18 years) who had a primary TKR for osteoarthritis were included. Studies of people with unicompartmental knee, patella-femoral or revision knee replacement were excluded. Recovery attributes were extracted from individual papers and grouped into recovery themes. RESULTS: A total of 23 studies with 8404 participants and 18 recovery themes were developed. The most frequently identified overarching theme was pain, followed by activities of daily living, mobility (walking), recreational activities, specific functional movements of the knee, use of walking aids, sexual activity and range of motion of the knee. Medical complications were an infrequently reported theme, however, was deemed to be high importance. CONCLUSIONS: Reducing pain, returning of activities and daily living and mobility are the three most frequently reported recovery domains for people after TKR. Clinicians should be aware of recovery themes, to ensure they are explored sufficiently when consenting for a TKR. Future research should aim to determine the relative importance of these attributes compared to each other. Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021253699.
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PURPOSE: The management of meniscal tears is a widely researched and evolving field. Previous studies reporting the incidence of meniscal tears are outdated and not representative of current practice. The aim of this study was to report the current incidence of MRI confirmed meniscal tears in patients with a symptomatic knee and the current intervention rate in a large NHS trust. METHODS: Radiology reports from 13,358 consecutive magnetic resonance imaging scans between 2015 and 2017, performed at a large UK hospital serving a population of 470,000, were assessed to identify patients with meniscal tears. The hospital database was interrogated to explore the subsequent treatment undertaken by the patient. A linear regression model was used to identify if any factors predicted subsequent arthroscopy. RESULTS: 1737 patients with isolated meniscal tears were identified in patients undergoing an MRI for knee pain, suggesting a rate of 222 MRI confirmed tears per 100,000 of the population aged 18 to 55 years old. 47% attended outpatient appointments and 22% underwent arthroscopy. Root tears [odds ratio (95% CI) 2.24 (1.0, 4.49); p = 0.049] and bucket handle tears were significantly associated with subsequent surgery, with no difference between the other types of tears. The presence of chondral changes did not significantly affect the rate of surgery [0.81 (0.60, 1.08); n.s]. CONCLUSION: Meniscal tears were found to be more common than previously described. However, less than half present to secondary care and only 22% undergo arthroscopy. These findings should inform future study design and recruitment strategies. In agreement with previous literature, bucket handle tears and root tears were significant predictors of subsequent surgery. LEVEL OF EVIDENCE: III.
Subject(s)
Knee Injuries , Tibial Meniscus Injuries , Adolescent , Adult , Arthroscopy , Humans , Knee Injuries/diagnosis , Knee Injuries/epidemiology , Knee Injuries/surgery , Magnetic Resonance Imaging , Menisci, Tibial , Middle Aged , Retrospective Studies , Tibial Meniscus Injuries/diagnostic imaging , Tibial Meniscus Injuries/epidemiology , Tibial Meniscus Injuries/surgery , Young AdultABSTRACT
INTRODUCTION: The use of arthroscopy to alleviate the symptoms of osteoarthritis has been questioned by recent high quality evidence. This has led to the development of guidelines by specialist and national bodies advocating against its use. AIMS: To examine the trends of the rates of arthroscopy in patients with knee osteoarthritis over the past five years and determining compliance with guidelines. METHODS: Multi-centre, retrospective audit in five hospital trusts in the United Kingdom. The number of arthroscopies performed by month from 2013 to 2017 was identified through hospital coding. Fifty randomly selected records from the year 2017 were further analysed to assess compliance with NICE guidelines. RESULTS: Between 2013 and 2017, the number of arthroscopies performed annually in five trusts dropped from 2028 to 1099. In the year 2017, 17.7% of patients with no mechanical symptoms and moderate-to-severe arthritis pre-operatively had arthroscopy. CONCLUSION: Knee arthroscopy continues to be used as a treatment for osteoarthritis, against national guidelines. Whilst overall numbers are declining, further interventions, including implementation of high-quality conservative care is required to further eliminate unnecessary procedures.
Subject(s)
Arthroscopy , Osteoarthritis, Knee , Humans , Knee Joint , Osteoarthritis, Knee/surgery , Retrospective Studies , United KingdomABSTRACT
A series of 2-phenyl-4,5,6,7-tetrahydro[b]benzothiophene derivatives were synthesized and evaluated for in vitro COX inhibitory potential. Within the series, compounds 4a, 4j, 4k, and 4q were identified as potential and selective COX-2 inhibitors with COX-2 IC50 in 0.31-1.40µM range; COX-2 selectivity index (SI)=48.8-183.8 range and they showed percent PGE-2 inhibitory activity in the range of 25.4-46.9. Further, compounds 4a, 4j, 4k and 4q displayed potent anti-inflammatory activity with percentage rise in paw volume ranging from 21.1-30.5 at 180min, while celecoxib demonstrated 19.6 percentage rise at the same dose at 180min in carrageenan-induced rat paw edema assay. Cell viability via MTT assay showed no cytotoxicity up to 80µM concentrations. Molecular docking study of potent compounds in the series showed Gscore comparable to celecoxib with similar binding orientation for the COX-2 active site which also corroborates the observed in vitro COX-2 inhibition.
Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/chemistry , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Cyclooxygenase 2 Inhibitors/chemistry , Cyclooxygenase 2 Inhibitors/therapeutic use , Edema/drug therapy , Thiophenes/chemistry , Thiophenes/therapeutic use , Animals , Anti-Inflammatory Agents, Non-Steroidal/chemical synthesis , Anti-Inflammatory Agents, Non-Steroidal/pharmacology , Carrageenan , Cyclooxygenase 2 Inhibitors/chemical synthesis , Cyclooxygenase 2 Inhibitors/pharmacology , Drug Design , Edema/pathology , Mice , Molecular Docking Simulation , RAW 264.7 Cells , Rats , Thiophenes/chemical synthesis , Thiophenes/pharmacologyABSTRACT
Neuroinflammation in Parkinson's disease [PD] is a process that occurs alongside the loss of dopaminergic neurons, and is associated with alterations to many cell types, most notably microglia. This review examines the key evidence contributing to our understanding of the role of inflammation-mediated degeneration of the dopaminergic (DA) nigrostriatal pathway in PD. It will consider the potential role inflammation plays in tissue repair within the brain, inflammation linked gene products that are associated with sporadic Parkinsonian phenotypes (alpha-synuclein, Parkin and Nurr 1), and developing anti-inflammatory drug treatments in PD. With growing evidence supporting the key role of neuroinflammation in PD pathogenesis, new molecular targets are being found that could potentially prevent or delay nigrostriatal DA neuron loss. Hence, this creates the opportunity for disease modifying treatment, to currently what is an incurable disease.
Subject(s)
Brain/physiology , Dopaminergic Neurons/pathology , Inflammation/pathology , Nerve Degeneration/pathology , Parkinson Disease/pathology , Animals , Anti-Inflammatory Agents/therapeutic use , Brain/drug effects , Brain/metabolism , Brain/pathology , Dopaminergic Neurons/metabolism , Genetic Predisposition to Disease/genetics , Humans , Inflammation/complications , Inflammation/metabolism , Microglia/metabolism , Nerve Degeneration/drug therapy , Parkinson Disease/complications , Parkinson Disease/drug therapy , Parkinson Disease/genetics , Parkinson Disease/metabolismABSTRACT
BACKGROUND: Medical students often struggle to engage in extra-curricular research and audit. The Student Audit and Research in Surgery (STARSurg) network is a novel student-led, national research collaborative. Student collaborators contribute data to national, clinical studies while gaining an understanding of audit and research methodology and ethical principles. This study aimed to evaluate the educational impact of participation. METHODS: Participation in the national, clinical project was supported with training interventions, including an academic training day, an online e-learning module, weekly discussion forums and YouTube® educational videos. A non-mandatory, online questionnaire assessed collaborators' self-reported confidence in performing key academic skills and their perceptions of audit and research prior to and following participation. RESULTS: The group completed its first national clinical study ("STARSurgUK") with 273 student collaborators across 109 hospital centres. Ninety-seven paired pre- and post-study participation responses (35.5%) were received (male = 51.5%; median age = 23). Participation led to increased confidence in key academic domains including: communication with local research governance bodies (p < 0.001), approaching clinical staff to initiate local collaboration (p < 0.001), data collection in a clinical setting (p < 0.001) and presentation of scientific results (p < 0.013). Collaborators also reported an increased appreciation of research, audit and study design (p < 0.001). CONCLUSIONS: Engagement with the STARSurg network empowered students to participate in a national clinical study, which increased their confidence and appreciation of academic principles and skills. Encouraging active participation in collaborative, student-led, national studies offers a novel approach for delivering essential academic training.
Subject(s)
Biomedical Research , Education, Medical, Undergraduate/methods , Medical Audit , Students, Medical , Adolescent , Adult , Attitude , Computer-Assisted Instruction , Cross-Sectional Studies , Data Collection , Female , General Surgery/education , Humans , Male , Perception , Schools, Medical , Students, Medical/psychology , Surveys and Questionnaires , United Kingdom , Young AdultABSTRACT
BACKGROUND AND PURPOSE: Virtual reality (VR) simulation offers a safe, controlled, and effective environment to complement training but requires extensive validation before it can be implemented within the curriculum. The main objective was to assess whether VR dynamic hip screw (DHS) simulation has a training effect to improve objective performance metrics. PATIENTS AND METHODS: 52 surgical trainees who were naïve to DHS procedures were randomized to 2 groups: the training group, which had 5 attempts, and the control group, which had only one attempt. After 1 week, both cohorts repeated the same number of attempts. Objective performance metrics included total procedural time (sec), fluoroscopy time (sec), number of radiographs (n), tip-apex distance (TAD; mm), attempts at guide-wire insertion (n), and probability of cut-out (%). Mean scores (with SD) and learning curves were calculated. Significance was set as p < 0.05. RESULTS: The training group was 68% quicker than the control group, used 75% less fluoroscopy, took 66% fewer radiographs, had 82% less retries at guide-wire insertion, achieved a reduced TAD (by 41%), had lower probability of cut-out (by 85%), and obtained an increased global score (by 63%). All these results were statistically significant (p < 0.001). The participants agreed that the simulator provided a realistic learning environment, they stated that they had enjoyed using the simulator, and they recognized the need for the simulator in formal training. INTERPRETATION: We found a significant training effect on the VR DHS simulator in improving objective performance metrics of naïve surgical trainees. Patient safety, an important priority, was not compromised.
Subject(s)
Bone Screws , Fracture Fixation, Internal/education , Hip Fractures/surgery , User-Computer Interface , Clinical Competence , Female , Fracture Fixation, Internal/instrumentation , Humans , Male , Time Factors , Young AdultABSTRACT
Open tibia fractures are devastating, life changing injuries, with infection associated with substantial morbidity to the patient. Reducing infection is a research priority, but before interventional studies can be designed, the incidence of infection following this injury needs to be better defined. Our aim was to estimate the global incidence of infection following an open tibia fracture. A systematic review was performed of MEDLINE, EMBASE, Central Register of Controlled Trials (CENTRAL), Web of Science and Global Index Medicus. We included randomised controlled trials with more than ten participants which reported infections after open diaphyseal or distal fractures (AO 42 or 43). Primary outcome was deep infection according to the Centres for Disease Control and Prevention criteria. Secondary outcome included causative micro-organisms. A meta-analysis using a random effects model to assess incidence and between-treatment effects was performed. Thirteen studies including 1463 adults from seven middle-income countries, seven high-income countries and one low-income country were included. The incidence of infection was 12.12 person-years (95% CI 7.95-18.47). A subgroup analysis compared external fixation and intramedullary nailing showed no difference between infection rates. There were limited data on organisms, but Staphylococcus aureus was the most commonly identified. There are limited to no data on antimicrobial resistance.
Subject(s)
Developing Countries , Fractures, Open , Tibial Fractures , Humans , Tibial Fractures/surgery , Tibial Fractures/complications , Tibial Fractures/epidemiology , Tibial Fractures/microbiology , Incidence , Fractures, Open/surgery , Fractures, Open/complications , Fractures, Open/microbiology , Fractures, Open/epidemiology , Developed Countries , Surgical Wound Infection/epidemiology , Surgical Wound Infection/microbiologyABSTRACT
INTRODUCTION: Currently there is no consensus on the need for investigating knee ligamentous and meniscal injuries in a patient with a tibial plateau fracture. Consequently, many soft tissue injuries are likely undiagnosed and therefore untreated. The impact this has on long term knee outcomes is not well defined. We aimed to identify the impacts of various diagnostic methods on the management of meniscal injuries associated with tibial plateau fractures and evaluate the clinical outcomes. MATERIALS AND METHODS: We performed a systematic review using Pubmed, Medline, Embase, CINAHL and Cochrane following Cochrane guidelines. We included studies that operatively managed tibial plateau fractures and soft tissue injuries, which were diagnosed with either preoperative MRI, intra-operative arthroscopy or arthrotomy. RESULTS: 18 articles with 884 people, with a mean age of 46.4 years were included. Soft tissue injuries were detected on MRI (32-73%) and arthroscopy (12-70%), of which the most common were lateral meniscal injuries (7-64% of tibial plateau fractures). When identified by arthroscopy and arthrotomy, these injuries were almost always treated, either by repair or debridement. The clinical outcomes of these patients were poorly reported, with a heterogenous use of patient reported outcome measures, and follow up time points. There were no randomised trials or control groups for comparative analysis, however operative treatment yielded good to excellent outcomes. CONCLUSION: There is a high incidence of concomitant soft tissue injuries with tibial plateau fractures, particularly lateral meniscal injuries. There are 2 main approaches to meniscal injuries: surgeons who don't investigate, don't treat, whilst surgeons who do investigate often do surgically treat. Although studies that treated these injuries achieved good to excellent results, the currently available evidence doesn't confirm treatment superiority. As there is plausibility for better outcomes, randomised studies are needed to further investigate this clinical question.
Subject(s)
Arthroscopy , Magnetic Resonance Imaging , Soft Tissue Injuries , Tibial Meniscus Injuries , Tibial Plateau Fractures , Humans , Arthroscopy/methods , Debridement/methods , Knee Injuries/surgery , Knee Injuries/diagnostic imaging , Soft Tissue Injuries/surgery , Soft Tissue Injuries/diagnostic imaging , Tibial Meniscus Injuries/surgery , Tibial Meniscus Injuries/diagnostic imaging , Tibial Plateau Fractures/diagnostic imaging , Tibial Plateau Fractures/surgeryABSTRACT
Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies.
Subject(s)
Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Randomized Controlled Trials as Topic , Robotic Surgical Procedures , Humans , Robotic Surgical Procedures/methods , Arthroplasty, Replacement, Knee/methods , Arthroplasty, Replacement, Hip/methods , Osteoarthritis, Hip/surgery , Osteoarthritis, Knee/surgery , Cost-Benefit AnalysisABSTRACT
BACKGROUND: Anterior cruciate ligament reconstruction (ACLR) is most commonly performed with hamstring tendon (HT) or bone-patellar tendon-bone (BTB) autografts, although the quadriceps tendon (QT) autograft has recently increased in popularity. This systematic review and meta-analysis review compares QT and HT autografts for primary ACLR with a sole focus on randomised controlled trials (RCTs). METHODS: A prospective protocol was registered on PROSPERO (CRD42023427339). The search included MEDLINE, Embase and Web of Science until February 2024. Only comparative RCTs were included. The primary outcome was the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form score. Secondary outcomes included: other validated patient-reported outcome measures (PROMs), objective strength scores, complications, and return to sport and work. RESULTS: From 2,609 articles identified, seven were included (n = 474 patients). This meta-analysis did not identify a significant difference in post-operative IKDC scores (5 articles; p = 0.73), Lysholm scores (3 studies; p = 0.80) or Tegner activity scales (2 studies; p = 0.98). There were no differences in graft failure rates (4 studies; p = 0.92) or in overall adverse events (4 studies; p = 0.83) at 24 months post-ACLR as per meta-analysis. Donor site morbidity scores were significantly lower in the QT group (MD -4.67, 95% CI -9.29 to -0.05; 2 studies, 211 patients; p = 0.05, I2 = 34%). CONCLUSION: There were no differences between QT and HT in PROMs, graft failure rates or overall complications based on low- to moderate-quality evidence. There may possibly be lower donor site morbidity with the QT autograft, however, the evidence is not sufficient to draw definitive conclusions.
Subject(s)
Anterior Cruciate Ligament Reconstruction , Hamstring Tendons , Randomized Controlled Trials as Topic , Humans , Anterior Cruciate Ligament Reconstruction/methods , Hamstring Tendons/transplantation , Anterior Cruciate Ligament Injuries/surgery , Quadriceps Muscle/transplantation , Tendons/transplantation , Autografts , Transplantation, AutologousABSTRACT
OBJECTIVES: To explore people's views of recovery from total knee replacement (TKR) and which recovery domains they felt were important. DESIGN: Semi-structured interviews exploring the views of individuals about to undergo or who have undergone TKR. A constant-comparative approach with thematic analysis was used to identify themes. The process of sampling, collecting data and analysis were continuous and iterative throughout the study, with interviews ceasing once thematic saturation was achieved. SETTING: Tertiary care centre. PARTICIPANTS: A purposive sample was used to account for variables including pre, early or late postoperative status. RESULTS: 12 participants were interviewed, 4 who were preoperative, 4 early postoperative and 4 late postoperative. Themes of pain, function, fear of complications, awareness of the artificial knee joint and return to work were identified. Subthemes of balancing acute and chronic pain were identified. CONCLUSIONS: The results of this interview-based study identify pain and function, in particular mobility, that were universally important to those undergoing TKR. Surgeons should consider exploring these domains when taking informed consent to enhance shared decision-making. Researchers should consider these recovery domains when designing interventional studies.
Subject(s)
Arthroplasty, Replacement, Knee , Interviews as Topic , Qualitative Research , Recovery of Function , Humans , Arthroplasty, Replacement, Knee/rehabilitation , Arthroplasty, Replacement, Knee/psychology , Female , Male , Aged , Middle Aged , Return to Work , Aged, 80 and over , Osteoarthritis, Knee/surgery , Pain, Postoperative/psychologyABSTRACT
BACKGROUND: The Forgotten Joint Score (FJS), a commonly used patient-reported outcome measure, was developed without fully confirming assumptions such as unidimensionality (all items reflect 1 underlying factor), appropriate weighting of each item in scoring, absence of differential item functioning (in which different groups, e.g., men and women, respond differently), local dependence (pairs of items are measuring only 1 underlying factor), and monotonicity (persons with higher function have a higher score). We applied item response theory (IRT) to perform validation of the FJS according to contemporary standards, and thus support its ongoing use. We aimed to confirm that the FJS reflects a single latent trait. In addition, we aimed to determine whether an IRT model could be fitted to the FJS. METHODS: Participants undergoing primary total knee replacement provided responses to the FJS items preoperatively and at 6 and 12 months postoperatively. An exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and Mokken analysis were conducted. A graded response model (GRM) was fitted to the data. RESULTS: A total of 1,774 patient responses were analyzed. EFA indicated a 1-factor model (all 12 items reflecting 1 underlying trait). CFA demonstrated an excellent model fit. Items did not have equal weighting. The FJS demonstrated good monotonicity and no differential item functioning by sex, age, or body mass index. GRM parameters are reported in this paper. CONCLUSIONS: The FJS meets key validity assumptions, supporting its use in clinical practice and research. The IRT-adapted FJS has potential advantages over the traditional FJS: it provides continuous measurements with finer granularity between health states, includes individual measurement error, and can compute scores despite more missing data (with only 1 response required to estimate a score). It can be applied retrospectively to existing data sets or used to deliver individualized computerized adaptive tests. LEVEL OF EVIDENCE: Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.
Subject(s)
Arthroplasty, Replacement, Knee , Patient Reported Outcome Measures , Humans , Male , Female , Aged , Middle Aged , Factor Analysis, Statistical , Osteoarthritis, Knee/surgery , Reproducibility of Results , Psychometrics , Aged, 80 and overABSTRACT
Background Virtual reality (VR) simulation is a potential solution to the barriers surgical trainees are facing. There needs to be validation for its implementation within current training. We aimed to compare VR simulation to traditional methods in acquiring surgical skills for a TFN-ADVANCED™ Proximal Femoral Nailing System (TFNA; DePuy Synthes, Auckland, New Zealand) femoral nailing system. Methods Thirty-one surgical trainees were randomised to two groups: traditional-training group (control group) and a VR-training group (intervention group) for insertion of a short cephalomedullary TFNA nail. Both groups then inserted the same TFNA system into saw-bone femurs. Surveys evaluated validity of the relevant activities, perception of simulation, confidence, stress and anxiety. The primary outcomes were tip-apex distance (TAD) and user anxiety/confidence levels. Secondary outcomes included number of screw- and nail-guidewire insertion attempts, the time taken to complete and user validity of the VR system. Results There was no statistical difference in TAD between the intervention and control groups (9mm vs 15mm, p=0.0734). The only TAD at risk of cut-out was in the control group (25mm). There was no statistical difference in time taken (2547.5ss vs 2395ss, p=0.668), nail guide-wire attempts (two for both groups, p=0.355) and screw guide-wire attempts (one for both groups, p=0.702). The control group versus intervention had higher anxiety levels (50% vs 33%) and had lower confidence (61% vs 84%). Interpretation There was no objective difference in performance on a saw-bone model between groups. However, this VR simulator resulted in more confidence and lower anxiety levels whilst performing a simulated TFNA. Whilst further studies with larger sample sizes and exploration of transfer validity to the operating theatre are required, this study does indicate potential benefits of VR within surgical training.
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INTRODUCTION: The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant-assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants' awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements. ETHICS AND DISSEMINATION: The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners. TRIAL REGISTRATION NUMBER: ISRCTN13374625.
Subject(s)
Arthroplasty, Replacement, Hip , Robotic Surgical Procedures , Humans , Cost-Effectiveness Analysis , Quality of Life , Arthroplasty, Replacement, Hip/methods , Pain , United Kingdom , Treatment Outcome , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
INTRODUCTION: Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. ETHICS AND DISSEMINATION: The trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN27624068.
Subject(s)
Arthroplasty, Replacement, Knee , Robotic Surgical Procedures , Humans , Cost-Effectiveness Analysis , Knee Joint , Arthroplasty, Replacement, Knee/methods , Pain , Cost-Benefit Analysis , Treatment Outcome , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
BACKGROUND: Meniscal tears affect 222 per 100,000 of the population and can be managed non-operatively or operatively with an arthroscopic partial meniscectomy (APM), meniscal repair or meniscal transplantation. The purpose of this review is to summarise the outcomes following treatment with a meniscal tear and explore correlations between outcomes. METHOD: A systematic review was performed of MEDLINE, EMBASE, AMED and the Cochrane Central Register of Controlled Trials to identify prospective studies describing the outcomes of patients with a meniscal tear. Comparisons were made of outcomes between APM and non-operative groups. Outcomes were graphically presented over time for all treatment interventions. Pearson's correlations were calculated between outcome timepoints. RESULTS: 35 studies were included, 28 reported outcomes following APM; four following meniscal repair and three following meniscal transplant. Graphical plots demonstrated a sustained improvement for all treatment interventions. A moderate to very strong correlation was reported between baseline and three-month outcomes. In the medium term, there was small significant difference in outcome between APM and non-operative measures (SMD 0.17; 95 % CI 0.04, 0.29), however, this was not clinically significant. CONCLUSIONS: Patients with a meniscal tear demonstrated a sustained initial improvement in function scores, which was true of all treatments examined. APM may have little benefit in older people, however, previous trials did not include patients who meet the current indications for surgery as a result the findings should not be generalised to all patients with a meniscal tear. Further trials are required in patients who meet current operative indications.
Subject(s)
Knee Injuries , Tibial Meniscus Injuries , Aged , Arthroscopy/adverse effects , Humans , Knee Injuries/etiology , Knee Injuries/surgery , Meniscectomy/adverse effects , Menisci, Tibial/surgery , Prospective Studies , Tibial Meniscus Injuries/etiology , Tibial Meniscus Injuries/surgeryABSTRACT
BACKGROUND: Open tibia fractures are a common injury following road traffic collisions and place a large economic burden on patients and healthcare systems. Summarising their economic burden is key to inform policy and help prioritise treatment. METHODS: All studies were identified from a systematic search of Medline, Embase and the Cochrane Central Register of Controlled Trials. We included any human with a diagnosed open tibia fracture, following any intervention. The primary outcome was any costs reported or patient return to work status. Secondary outcomes included average length of stay, wage loss, absenteeism and complications such as infection, amputation and nonunion. Data was extracted and we performed a descriptive narrative summary. RESULTS: We reviewed 1,204 studies from our searches. A total of 34 studies were included from 14 different countries. The average age was 37.7 years old and 76% of the patients were male. 6.5% were Gustilo I, 12% Gustilo II and 82% Gustilo III. Initial direct hospitalisation costs were reported to be between £356 to £126,479 with an average length of stay of 56 days (3.1-244). 89% of participants were working pre-injury, 60% fully returned to work, 17% returned to work part time or changed profession and 22% did not return to work at one-year. The most common complications reported were 22% infection, 11% nonunion and 16% amputation. Mean follow-up duration for the studies was 25 months. CONCLUSION: The economic burden of open tibia fractures varies greatly, but it is costly for both hospitals and patients. The current evidence is predominantly from high-income countries (HICs), especially the USA. Further research is required to investigate the costs of open tibia fractures using validated costing tools, especially in low-income countries (LICs), to help inform and direct policy.