Abstract. Objectives. To compare the effectiveness of phonophoresis (PH) and conventional therapeutic ultrasound (US) on the functional and pain outcomes of patients with knee osteoarthritis. Methods. We conducted an electronic search through PubMed, Cochrane Central Register of Clinical Trials (CENTRAL), Web of Science (WOS), and Scopus databases. We screened the retrieved articles to include only English full-text randomized controlled trials that examined the effect of phonophoresis versus conventional therapeutic ultrasound on patients with knee osteoarthritis. Two reviewers screened, extracted the data, and independently assessed the quality of the included articles. Results. A total of five randomized controlled trials met our inclusion criteria out of 267 studies screened. Our results showed no statistically significant differences between the PH and US groups (1), (2), (3),(4), and (5). The PH group demonstrated more significant effects than the UT group in reducing VAS pain scores (P=0.009) and improving WOMAC scores, although this did not reach the level of significance (P=0.143) (5). In the long term, PH therapy was found to be superior to US in improving painless walking duration and distance VAS scores (p=0.034, 0.017) respectively, as well as walking and resting walking VAS scores (p=0.03, 0.007) respectively, which were found to be permanent (3). Conclusions. Both therapies improve pain and function. However, we suggest conducting more high-quality trials with larger sample sizes and do not recommend the use of these therapies in clinical practice due to limitations in gender selection and high risk of bias. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Total knees today are performed with the use of standard trials that the surgeon utilises to define appropriate implant rotation, range of motion, and soft tissue balance. This “feel” based approach is very subjective, and lacks a quantifiable approach to interpret our intra-operative knee assessment. Sensor-based trials are embedded into the specific knee designed tibial trial, and wirelessly displays data related to the implant's position and ligament tension. The surgeon can now identify malrotation, soft tissue imbalance, and instability through a full ROM. The surgeon can see dynamic responses to ligament releases, alignment changes, and implant adjustments. As Insall taught us; a TKR is a soft tissue procedure, and a “balanced” knee will demonstrate improved outcomes and greater patient satisfaction. Smart Trials allow us to discuss how our intra-operative techniques affect our patient's outcomes. This surgery will utilise Smart Trials during a Cruciate Retaining TKR

Extracapsular Hip Fractures (EHF's) are a significant health burden on healthcare services. Optimal treatment is controversial with conflicting evidence being reported. Currently treatment is undertaken with Intramedullary Nail (IMN) or Dynamic Hip Screw (DHS) constructs with a recent increase in IMN use (1). This study aims to conduct a systematic review of Randomised Control Trials published between 2020 and 2023 with particular focus on patient demographics and holistic patient outcomes. Using a unified search-protocol, RCT's published between 2020 and 2023 were collected from CENTRAL, PubMed, MEDLINE and EMBASE. Rayyan software screened duplicates. Using the CASP and Cochrane Risk of Bias Tool papers were critically examined twice, and Blood Loss, Infection and Mobility described the patient journey. Patient demographics were recorded and were contrasted with geographically diverse cohort studies to compare population differences. Parametric tests were used to determine significance levels between population demographics, namely Age and Sex. Eleven papers were included, representing 908 patients (436 Male). The mean age for patients was 64.39. There was considerable risk of bias in 7/11 studies owing to the randomization process and the recording of data. Four Cohort studies were selected for comparison representing 14314 patients. Mean age was significantly different between Cohort Studies and RCT's (Independent T-Test, df 13, t=7.8, p = <0.001, mean difference = 19.251, 95% CI = 13.888, 24.613). This was also true for sex ratios included in the studies (df 13, t = -2.268, p = 0.024, Mean Difference = -0.4884, 95% CI = -0.9702, -0.0066). To conclude, RCT's published in the post COVID-19 era are not representative of patient demographics. This has the potential to provide inaccurate information for implant selection. Additionally further research must be conducted in how to better improve RCT patient inclusion so as to be more representative of patients whilst balancing the risks of operations

Persistent post-surgical pain affects 10%-80% of individuals after common operations, and is more common among patients with psychological factors such as depression, anxiety, or catastrophising. We conducted a systematic review and meta-analysis of randomised, controlled trials to evaluate the efficacy of perioperative psychotherapy for persistent postsurgical pain and physical impairment. We searched Medline, PsycINFO, CINAHL, and the Cochrane Central Registry of Controlled Trials to identify relevant RCTs, in any language, from inception of each database to September 1, 2016. Paired independent reviewers identified studies, extracted data, and assessed risk of bias. We pooled treatment effects of perioperative psychotherapy on similar outcomes across eligible trials, focusing on intention-to-treat analysis. We used random effects models to perform all meta-analyses. The Grading of Recommendations, Assessment, Development and Evaluation system was used to assess the quality of evidence. Our search found 15 trials (2220 patients) that were eligible for review. For both persistent post-surgical pain and physical impairment, perioperative education was ineffective, while active psychotherapy suggested a benefit (test of interaction P=0.01 for both outcomes). Moderate quality evidence showed that active perioperative psychotherapy (cognitive-behaviour therapy, relaxation therapy, or both) significantly reduced persistent post-surgical pain [weighted mean difference (WMD) −1.06 cm on a 10 cm visual analogue scale for pain, 95% confidence interval (CI) −1.56 to −0.55 cm, risk difference (RD) for achieving no more than mild pain (3 cm or less) 14%, 95% CI 8–21%] and physical impairment [WMD −9.87% on the 0–100% Oswestry Disability Index, 95% CI −13.42 to −6.32%, RD for achieving no more than mild disability (20% or less) 21%, 95% CI 13–29%]. Perioperative cognitive behavioural therapy and relaxation therapy are effective for reducing persistent pain and physical impairment after surgery. High quality evidence shows no significant effects of perioperative education or psychological support on persistent post-surgical pain or physical impairment compared with usual care. Future studies should explore targeted psychotherapy for surgical patients at higher risk for poor outcome

Cite this article: Bone Joint Res 2023;12(6):372–374.

Investigator-Driven Clinical Trials (IDCT) form a key part of patient-oriented clinical research, the basis for continually improving patient care. Such research is under strain in Europe for a multiplicity of reasons, and because of this the European Medical Research Councils (EMRC) of the ESF has undertaken in 2007 a Forward Look exercise. This Forward Look represents what is probably the most comprehensive examination of IDCT in Europe in recent years. A thorough analysis of the problems faced by academic investigators conducting IDCT was carried out through a series of workshops covering different themes and attended by active and acknowledged experts in the field. These workshops identified specific issues that need to be addressed:. - Categories and Design of Investigator-Driven Clinical Trials. - Regulatory and Legal Issues, Intellectual Property Rights and Data Sharing. - Management of Investigator-Driven Clinical Trials. - Education, Training, Career Tracks and Authorship. - Funding and Models of Partnership. - Status of Investigator-Driven Clinical Trials in Central and Eastern European Countries. A range of possible solutions were proposed and five among the 26 recommendations as ranked by the consensus conference, held on 29–30 September 2008, were considered as top priorities to strengthen IDCT in Europe:. To improve the education, training and career structure for scientists involved in patient-oriented clinical research. To increase levels of funding for IDCT. To adopt a ‘risk-based’ approach to the regulation of IDCT. To streamline procedures for obtaining authorisation for IDCT. To ensure that IDCT are carried out with an appropriate number of patients to produce statistically reliable results – that the trials are ‘correctly powered’. To help implement the recommendations expressed in the report for strengthening patient oriented research in Europe a broad dissemination to the four stakeholder groups identified as key players will be assured.We clearly think that if we can collaborate on this important issue and improve conditions for clinical research, we can contribute to bringing better health and prosperity to Europe

A commonly misunderstood principle in medical literature is statistical significance. Often, statistically non-significant or negative results are thought to be evidence for equivalence; mistakenly validating treatment modalities and putting patients at risk. This study examines the prevalence of misinterpretation of negative results of superiority trials in orthopaedic literature and outlines the need for a non-inferiority or equivalence research design.

Four orthopaedic journals – Journal of Paediatric Orthopaedics A, Journal of Bone and Joint Surgery American Volume, Journal of Arthroplasty and Journal of Shoulder and Elbow Surgery – were hand searched to identify all randomised control trials (RCTs) published within the time periods 2002–2003, 2007–2008 and 2012–2013. The identified RCTs were read and classified by study methodology, results obtained, and interpretation of results.

A total of 237 RCTs were identified. When analysing the primary outcomes, 117 (49.4%) studies yielded negative results and 120 (50.8%) yielded positive results. Out of the 237 articles, 231 (97.5%) used superiority methodology and 6 (2.5%) used non-inferiority or equivalence methodology. Of the 231 studies that used superiority methodology, 115 (49.8%) obtained negative results; and 45 (39.1%) of those misinterpreted the negative results for equivalence. While no statistical differences were seen, there was an upward trend in utilising non-inferiority and equivalence methodologies over time.

Given the frequency of misinterpreted negative results, there is an evident need for a more appropriate research methodology that shows equivalence of treatment methods. A non-inferiority or equivalence study design can address orthopaedic clinical dilemmas more suitably when trying to show one treatment is no worse or is equal to another treatment. Regarding orthopaedic treatment modalities as equivalent when studies show negative statistical results can be detrimental to patients and their clinical outcomes. A non-inferiority methodology can be used to accurately depict no difference between treatment methods rather than attempting to show one treatment method as superior.

Introduction. There is an ever increasing demand for Randomised Controlled Trials (RCTs) in Trauma and Orthopaedic Surgery. Patient recruitment is often challenging. Among other factors, individual surgeon's preference is often quoted as a major obstacle. Collective equipoise based on present or imminent controversy in the expert medical community has been proposed as a solution, but could not help in everyday running of a trial. We wanted to develop a new trial eligibility assessment tool using the Collective Equipoise Principle. Methods. We developed an online system that quantifies collective uncertainty among a group of surgeons for an individual clinical case in real time. This data was collected for patients in the UK Heel Fracture Trial (UK HeFT) as an independent research project. Both patients who agreed or not to take part in the trial were approached in six weeks follow up clinic to avoid interference with clinical course. For those who agreed, anonymous clinical data together with images (Xrays and CT) was published on a secure on line forum and registered surgeons were alerted via email and SMS. Surgeons submitted their opinion instantly via specially designed interactive voting scale. 80:20 ethical uncertainty distribution limit was applied using Subjective Logic to calculate an Uncertainty Index (UnIx) for every patient. This approach was evaluated as an eligibility assessment tool for RCTs. Results. 70 consecutive patients (77 calcaneal fractures) were assessed by a panel of 12 Consultant Trauma surgeons from hospitals acros the UK. All patients were eligible for the UK HeFT according to standard eligibility criteria approach. UnIx demonstrated reliable correlation with level of uncertainty and confidence about treatment choice expressed by surgeons. The panel was certain about treatment for 9 (13%) patients. The assesment results were available within 48 hours from a case submission to the panel. Discussion and Conclusion. UnIx is an effective and ethical eligibility assessment tool based on surgeon's opinion. It can be calculated for every patient in Randomised Controlled Trials. This protects patients when there is no controversy about treatment choice. UnIx can potentially increase patient recruitment by including more patients for eligibility assessment and more sceptical surgeons in clinical trials. Patient's perception that his/her condition was assessed by surgical panel may also be important

Background: The nature and frequency of complications during or after orthopaedic interventions represent critical clinical information for safety evaluations, which are required in the development or improvement of medical procedures and devices. However, neither uniform definitions nor established classifications about the reporting of complications exist. So complication reporting, even in orthopaedic trials is still up to the surgeons perception and understanding. The goal of this systematic review was to check whether essential data are consistently provided by the authors in the assessment of incidence, severity and characteristics of complications related to orthopaedic interventions in randomized controlled trials.

Methods: Five major, peer-reviewed orthopaedic journals were screened for published randomized controlled trials (RCTs) between January 2006 and July 2007. All relevant papers were obtained, anonymized and evaluated by two external reviewers. A checklist consisting of three main parts: definition, evaluation and reporting was developed and applied for the assessment of complication reporting in RCTs. The results were stratified for the main area of the trial.

Results: One hundred and twelve RCTs meeting our inclusion criteria were identified. The majority of RCTs (n = 73) reported on surgical treatment methods, with most of the trials focussing on arthroplasty (38%); surgical fracture treatment and other surgical interventions accounted for 13% each. Although complications were included as trial outcomes in two thirds of the studies, clear definitions of anticipated complications were provided at least partly in only two trials of fracture treatment and six other trials. It remained unclear whether authors considered the specific events “death”, “mal-union”, “impaired function” and “re-operation” as complications; “impaired function” was not considered as a complication in 93% of the trials and “re-operation” events were considered in only 50% of the trials dealing with surgical fracture treatments. In 83% of RCTs, the identity of the person or group assessing the complications was unknown and in a further 8%, this process was implemented by the treating surgeon. This review did not identify any trial involving a Data Safety Review Board for assessment and classification of complications.

Conclusions: Due to the lack of homogeneity among the published trials, improvement in the reporting of complications is necessary. A standardized protocol for assessing and reporting complications should be developed and endorsed by professional organizations and most importantly, clinical investigators.

Background

Complex interventions, such as exercise for LBP, often have many treatment targets. Matching a primary outcome to the target(s) of exercise interventions may provide greater standardized mean differences (SMDs) than using an unmatched primary outcome. We aimed to explore whether the conclusions of exercise trials for LBP might differ with i) improved matching of outcomes to treatment targets and ii) the use of composite outcome measures.

Intra-articular injection is a common way to deliver biologics to joints, but their effectiveness is limited by rapid clearance from the joint space. This barrier can be overcome by genetically modifying cells within the joint such that they produce anti-arthritic gene products endogenously, thereby achieving sustained, therapeutic, intra-articular concentrations of the transgene products without re-dosing. A variety of non-viral and viral vectors have been subjected to preclinical testing to evaluate their suitability for delivering genes to joints. The first transfer of a gene to a human joint used an ex vivo protocol involving retrovirally transduced, autologous, synovial fibroblasts. Recent advances in vector technology allow in vivo delivery using adeno-associated virus (AAV). We have developed an AAV vector encoding the interleukin-1 receptor antagonist (AAV.IL-1Ra) for injection into joints with osteoarthritis (OA). It showed efficacy and safety in equine and rat models of OA, leading to a recently-completed, investigator-initiated, Phase I, dose-escalation clinical trial in 9 subjects with mid-stage OA of the knee (ClinicalTrials.gov Identifier: NCT02790723). Three cohorts of three subjects with mild to moderate OA in the index knee were injected intra-articularly under ultrasound guidance with a low (10e11 viral genomes) medium (10e12 viral genomes) or high (10e13 viral genomes) dose of AAV.IL-1Ra and followed for one year. The data confirm safety, with evidence of sustained intra-articular expression of IL-1Ra and a clinical response in certain subjects. Funding for a subsequent Phase Ib trial involving 50 subjects (ClinicalTrials.gov Identifier: NCT05835895), expected to start later this year, has been acquired. Progress in this area has stimulated commercial activity and there are now at least seven different companies developing gene therapies for OA and a number of clinical trials are in progress.

Acknowledgement: Clinical trial funded by US Department of Defense Clinical Trial Award W81XWH-16-1-0540.

Objectives. The objective of this study was to perform a meta-analysis of all randomised controlled trials (RCTs) comparing surgical and non-surgical management of fractures of the proximal humerus, and to determine whether further analyses based on complexity of fracture, or the type of surgical intervention, produced disparate findings on patient outcomes. Methods. A systematic review of the literature was performed identifying all RCTs that compared surgical and non-surgical management of fractures of the proximal humerus. Meta-analysis of clinical outcomes was performed where possible. Subgroup analysis based on the type of fracture, and a sensitivity analysis based on the type of surgical intervention, were also performed. Results. Seven studies including 528 patients were included. The overall meta-analysis found that there was no difference in clinical outcomes. However, subgroup and sensitivity analyses found improved patient outcomes for more complex fractures managed surgically. Four-part fractures that underwent surgery had improved long-term health utility scores (mean difference, MD 95% CI 0.04 to 0.28; p = 0.007). They were also less likely to result in osteoarthritis, osteonecrosis and non/malunion (OR 7.38, 95% CI 1.97 to 27.60; p = 0.003). Another significant subgroup finding was that secondary surgery was more common for patients that underwent internal fixation compared with conservative management within the studies with predominantly three-part fractures (OR 0.15, 95% CI 0.04 to 0.63; p = 0.009). Conclusion. This meta-analysis has demonstrated that differences in the type of fracture and surgical treatment result in outcomes that are distinct from those generated from analysis of all types of fracture and surgical treatments grouped together. This has important implications for clinical decision making and should highlight the need for future trials to adopt more specific inclusion criteria. Cite this article: S. Sabharwal, N. K. Patel, D. Griffiths, T. Athanasiou, C. M. Gupte, P. Reilly. Trials based on specific fracture configuration and surgical procedures likely to be more relevant for decision making in the management of fractures of the proximal humerus: Findings of a meta-analysisBone Joint Res 2016;5:470–480. DOI: 10.1302/2046-3758.510.2000638

Introduction: Randomized Controlled Trials (RCT) are the golden standard in nowadays evidence based outcome assessment. Nevertheless, RCTs in surgery are associated with several concerns. The major concern focuses on ethical issues when randomization is done. Method: We conducted an indebt analysis on advantages and disadvantages of three types of data acquisition (Case Control Study (CCS), RCT, and Registries) where scientific impact, ability to assess changes over time, cost efficiency, time consumption, ability to provide bench marks and other variables are compared. Results: RCTs are best regarding the scientific impact. Registers are superior in detecting changes over time (post market surveillance, early warning system), cost efficiency, time consumption, ability to provide benchmarks, local/national/international comparability and ability to let private practitioners participate. CCSs are of minor value in respect to all the assessed variables. Conclusion: In Surgery, registries are an excellent alternative to RCTs if a great majority of the treating physicians (in respect to a therapy) participate and if all the treated patients (per physician) are included. The register increases its scientific impact if alternative therapies are included (control). In this case, the scientific impact of a register is getting nearly equivalent to RCTs. Take home message: If ethical aspects allow an RCT, than the RCT is the study set up of choice when a new technique/implant has to be introduced in the market. Once the implant has proved its evidence, the following post market surveillance should be accompanied by registries (introduction of an implant in each country). If an RCT is not indicated (ethical or other contra indications), than registries should be used to prove evidence for an indicated therapy. CCSs are not recommended

Many orthopaedic procedures require implants to be trialled before definitive implantation. Where this is required, the trials are provided in a set with the instrumentation. The most common scenario this is seen in during elective joint replacements. In Scotland (2007) the Scottish Executive (. http://www.sehd.scot.nhs.uk/cmo/CMO(2006)13.pdf. ) recommended and implemented individually packed orthopaedic implants for all orthopaedic sets. The premise for this was to reduce the risk of CJD contamination and fatigue of implants due to constant reprocessing from corrosion. During many trauma procedures determining the correct length of plate or size of implant can be challenging. Trials of trauma implants is no longer common place. Many implants are stored in closed and sealed boxes, preventing the surgeon looking at the implant prior to opening and contaminating the device. As a result many implants are incorrectly opened and either need reprocessed or destroyed due to infection control policy, thus implicating a cost to the NHS. With even the simplest implants costing several hundreds of pounds, this cost is a very significant waste in resources that could be deployed else where. My project was to develop a method to produce in department accurate, cheap and disposable trials for implants often used in trauma, where the original manufacturer do not offer the option of a trial off the shelf. The process had to not involve contaminating or destroying the original implant in the production of a trial. Several implants which are commonly used within Glasgow Royal Infirmary and do not have trials were identified. These implants were then CT scanned within their sealed and sterile packaging without contamination. Digital 3D surface renders of the models were created using free open source software (OsiriX, MeshLab, NetFabb). These models were then processed in to a suitable format for 3D printing using laser sintering via a cloud 3D printing bureau (. Shapeways.com. ). The implants were produced in polyamide PA220 material or in 316L stainless steel. These materials could be serialized using gamma irradiation or ethylene oxide gas. The steel models were suitable for autoclaving in the local CSSU. The implants produced were accurate facsimiles of the original implant with dimensions within 0.7mm. The implants were cost effective, an example being a rim mesh was reproduced in polyamide PA220 plastic for £3.50 and in 316L stainless steel for £15. The models were produced within 10 days of scanning. The stainless steel trials were durable and suitable for reprocessing and resterilisation. The production of durable, low cost and functional implant trials all completed in department was successful. The cost of production of each implant is so low that it would be offset if just one incorrect implant was opened during a single procedure. With some of the implants tested, the trials would have paid for themselves 100 times. This is a simple and cost saving technique that would help reduce department funding and aid patient care

Purpose: A significant proportion of spine fusion operations may result in a non-union. Electromagnetic stimulation is a non-invasive method used to promote spine fusion although the efficacy of its use in this regard remains uncertain. The purpose of this systematic review and meta-analysis is to evaluate the effect of electromagnetic stimulation on spine fusion. Method: Five electronic databases (MEDLINE, Embase, CINAHL, PubMed and the Cochrane Central Register of Controlled Trials) were searched from database inception to July 2009 for randomized controlled trials of electrical stimulation and spinal fusion. In addition, we performed a hand search of four relevant journals from January 2000 to July 2009, the on-line proceedings of the North American Spine Society Annual Meeting from 2002 to 2008 and bibliographies of eligible trials. Trials randomizing adult patients undergoing any type of spine fusion to active treatment with direct current, capacitance coupled or pulsed electromagnetic field stimulation or placebo and reporting on fusion rates were included. Two independent reviewers extracted data regarding clinical outcomes, stimulation device, treatment regimen and methodologic quality. Results: Of 1650 studies identified seven met the inclusion criteria. Electromagnetic stimulation in lumbar spine fusion was evaluated in five studies and two addressed cervical spine fusions. The use of electromagnetic stimulation in lumbar spine fusion resulted in a significant decrease in the risk of non-union (relative risk 0.60, 95% confidence interval 0.38 to 0.93, p = 0.02, I2 = 57%). The observed reduction in risk of nonunion with electromagnetic stimulation was not affected by smoking or the number of levels fused. Due to limited and conflicting trials, similar effects were not observed in the two studies evaluating cervical spine fusion rates (relative risk 0.85, 95% confidence interval 0.29 to 2.53, p = 0.77, I2 = 56%). Conclusion: Pooled analysis shows a 40% reduction in the risk of non-union of lumbar spine fusions with the use of electromagnetic stimulation although a similar effect was not observed for fusions of the cervical spine. However, due to study heterogeneity the current indications for the use of electrical stimulation in spine fusion remain somewhat unclear

Many orthopaedic procedures require implants to be trialled before definitive implantation. Where this is required, the trials are provided in a set with the instrumentation. The most common scenario this is seen in during elective joint replacements. In Scotland (2007) the Scottish Executive (. http://www.sehd.scot.nhs.uk/cmo/CMO(2006)13.pdf. ) recommended and implemented individually packed orthopaedic implants for all orthopaedic sets. The premise for this was to reduce the risk of CJD contamination and fatigue of implants due to constant reprocessing from corrosion. During many trauma procedures determining the correct length of plate or size of implant can be challenging. Trials of trauma implants is no longer common place. Many implants are stored in closed and sealed boxes, preventing the surgeon looking at the implant prior to opening and contaminating the device. As a result many implants are incorrectly opened and either need reprocessed or destroyed due to infection control policy, thus implicating a cost to the NHS. With even the simplest implants costing several hundreds of pounds, this cost is a very significant waste in resources that could be deployed else where. My project was to develop a method to produce in department accurate, cheap and disposable trials for implants often used in trauma, where the original manufacturer do not offer the option of a trial off the shelf. The process had to not involve contaminating or destroying the original implant in the production of a trial. Several implants which are commonly used within Glasgow Royal Infirmary and do not have trials were identified. These implants were then CT scanned within their sealed and sterile packaging without contamination. Digital 3D surface renders of the models were created using free open source software (OsiriX, MeshLab, NetFabb). These models were then processed in to a suitable format for 3D printing using laser sintering via a cloud 3D printing bureau (. Shapeways.com. ). The implants were produced in polyamide PA220 material or in 316L stainless steel. These materials could be serialized using gamma irradiation or ethylene oxide gas. The steel models were suitable for autoclaving in the local CSSU. The implants produced were accurate facsimiles of the original implant with dimensions within 0.7mm. The implants were cost effective, an example being a rim mesh was reproduced in polyamide PA220 plastic for £3.50 and in 316L stainless steel for £15. The models were produced within 10 days of scanning. The stainless steel trials were durable and suitable for reprocessing and resterilisation. The production of durable, low cost and functional implant trials all completed in department was successful. The cost of production of each implant is so low that it would be offset if just one incorrect implant was opened during a single procedure. With some of the implants tested, the trials would have paid for themselves 100 times. This is a simple and cost saving technique that would help reduce department funding and aid patient care

Background and Purpose

The UK's NIHR and Australia's NHMRC have funded two randomised controlled trials (RCTs) to determine if lumbar fusion surgery (LFS) is more effective than best conservative care (BCC) for adults with persistent, severe low back pain (LBP) attributable to lumbar spine degeneration. We aimed to describe clinicians’ decision-making regarding suitability of patient cases for LFS or BCC and level of equipoise to randomise participants in the RCTs.

Backgroud:. Periarticular multimodal drug injection (PMDI) during total knee arthroplasty (TKA) has been reported with promising effects, but some results still remain controversial. Therefore, we conducted a systematic review and meta-analysis based on randomized controlled trials (RCTs) to evaluate the efficiency and safety of PMDI technique in TKA. Methods:. We systematically conducted an electronic search in the databases of PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science (SCI), and the Chinese Biomedical Literature Database (CBM). Two independent reviewers completed data collection and assessment of methodological quality according to the Cochrane Handbook 5.1. The quality of evidence of outcomes was judged using GRADE criteria. Statistical analysis was performed using the RevMan 5.1 software. Results:. Ten studies including eight trials with 1216 TKAs in 835 patients met the inclusion criteria. The short-term results of meta-analysis showed that technique of PMDI in TKA was associated with significantly improved pain scores on the day of surgery and postoperative 1 day [MD = −1.07, 95% CI (−1.43, −0.71), p < 0.01], better straight leg raise[OR = 4.02, 95% CI (2.25, 7.18), p < 0.01], reduced narcotic consumption within postoperative 24 hours [MD = −4.83, 95% CI (−6.61, −3.05), p < 0.01], and less rates of nausea or vomiting, and rash or pruritus [OR = 0.34, 95% CI (0.22, 0.55), p < 0.01]. There were no statistically significant differences in operating time [MD = 0.17, 95% CI (−1.48, 1.82), p = 0.84], hospital stay [MD = −0.20, 95% CI (−1.18, 0.79), p = 0.70], wound complication [OR = 0.79, 95% CI (0.31, 2.04), p = 0.63] and deep vein thrombosis [OR = 0.87, 95% CI (0.42, 1.78), p = 0.69] between both groups. Conclusions:. Periarticular injection with multimodal drugs in TKA has significant short-term advantages in pain relief, functional recovery, and narcotic consumption with fewer rates of complications (nausea or vomiting and rash or pruritus). Further well-designed RCTs are still needed to investigate the long-term efficiency of PMDI in patients undergoing TKA

Background

Advice and education are considered vital components of back pain care within national guidelines. However, a recent systematic review only found low grade evidence for a small average effect. They also reported wide heterogeneity in intervention design and delivery. This review aimed to understand why intervention design varied and what limited effectiveness by examining the underlying theoretical foundations of the studies from that review.

In recent literature, the fragility index (FI) has been used to evaluate the robustness of statistically significant findings of dichotomous outcomes. This metric is defined as the minimum number of outcome events to flip study conclusions from significant to nonsignificant. Orthopaedics literature is frequently found to be fragile with a median FI of 2 in 150 RCTs across spine, hand, sports medicine, trauma and orthopaedic oncology studies. While many papers discuss limitations of FI, we aimed to further characterize it by introducing the Fragility Likelihood (FL), a new metric that allows us to consider the probability of the event to occur and to calculate the likelihood of this fragility to be reached.

We systematically reviewed all randomized controlled trials in the Journal of Bone and Joint Surgery (Am) over 10 years. The FL was calculated with the following formula: A x B x C x 100% (A= FI; B = probability of the event in the group with the smallest number of events; C= probability of the non-event in the group with the highest number of events). A smaller FL demonstrates more robust results and conversely, a larger FL illustrates a higher likelihood of fragility being reached and more fragile the findings.

The median FI for the statistically significant outcomes was 2 (Mean: 3.8; Range 0-23). The median FL for the statistically significant outcomes was 11% (Mean: 22%, Range: 2%-73%). This means that the probability of reaching non-significance is only 11% when considering the probability of the event to occur. When comparing studies with the same FI we found the FL to range from 3% to 43%. This illustrates the large differences in robustness between trials with equal FI when the likelihood of the event was taken into consideration.

As orthopaedic studies are frequently reported as fragile, we found that by calculating the FL, studies may be more robust than previously assumed based off FI alone. By using the FL in conjunction with FI and p-values will provide additional insight into the robustness of the reported outcomes. Our results indicate that by calculating the FL, study conclusions are stronger than what the FI alone predicts. Although conducting RCTs in surgery can be challenging, we must endeavor to critically evaluate our results so we can answer important orthopaedic questions with certainty.