Aims. Systematic reviews of randomized controlled trials (RCTs) are the highest level of evidence used to inform patient care. However, it has been suggested that the quality of randomization in RCTs in orthopaedic surgery may be low. This study aims to describe the quality of randomization in trials included in systematic reviews in orthopaedic surgery. Methods. Systematic reviews of RCTs testing orthopaedic procedures published in 2022 were extracted from PubMed, Embase, and the Cochrane Library. A random sample of 100 systematic reviews was selected, and all included RCTs were retrieved. To be eligible for inclusion, systematic reviews must have tested an orthopaedic procedure as the primary intervention, included at least one study identified as a RCT, been published in 2022 in English, and included human clinical trials. The Cochrane Risk of Bias-2 Tool was used to assess random sequence generation as ‘adequate’, ‘inadequate’, or ‘no information’; we then calculated the proportion of trials in each category. We also collected data to test the association between these categories and characteristics of the RCTs and systematic reviews. Results. We included 917 unique RCTs. We found that 374 RCTs (40.8%) reported adequate sequence generation, 61 (6.7%) were inadequate, 410 (44.7%) lacked information, and 72 (7.9%) were observational studies incorrectly included as RCTs within the systematic review. Publication year, an author with statistical or epidemiological qualifications, and journal impact factor were each associated with adequate randomization. We found that 45 systematic reviews (45%) included at least one inadequately randomized RCT or an observational study incorrectly treated as a RCT. Conclusion. There is evidence of a lack of random allocation in RCTs included in systematic reviews in orthopaedic surgery. The conduct of RCTs and systematic reviews should be improved to minimize the risk of bias from inadequate randomization in RCTs and mislabelling of non-randomized studies as RCTs. Cite this article: Bone Jt Open 2024;5(12):1072–1080

Aims. The aim of this study was to investigate surgeons’ reported change of treatment preference in response to the results and conclusion from a randomized contolled trial (RCT) and to study patterns of change between subspecialties and nationalities. Methods. Two questionnaires were developed through the Delphi process for this cross-sectional survey of surgical preference. The first questionnaire was sent out before the publication of a RCT and the second questionnaire was sent out after publication. The RCT investigated repair or non-repair of the pronator quadratus (PQ) muscle during volar locked plating of distal radial fractures (DRFs). Overall, 380 orthopaedic surgeons were invited to participate in the first questionnaire, of whom 115 replied. One hundred surgeons were invited to participate in the second questionnaire. The primary outcome was the proportion of surgeons for whom a treatment change was warranted, who then reported a change of treatment preference following the RCT. Secondary outcomes included the reasons for repair or non-repair, reasons for and against following the RCT results, and difference of preferred treatment of the PQ muscle between surgeons of different nationalities, qualifications, years of training, and number of procedures performed per year. Results. Of the 100 surgeons invited for the second questionnaire, 74 replied. For the primary outcome, six of 32 surgeons (19%), who usually repaired the PQ muscle and therefore a change of treatment preference was warranted, reported a change of treatment preference based on the RCT publication. Of the secondary outcomes, restoring anatomy was the most common response for repairing the PQ muscle. Conclusion. The majority of the orthopaedic surgeons, where a change of treatment preference was warranted based on the results and conclusion of a RCT, did not report willingness to change their treatment preference. Cite this article: Bone Joint Open 2020;1-9:549–555

Introduction. We hereby present results of controlled randomized trial of use of popliteal block for pain relief in ankle and hind foot surgery. Materials and methods. We have studied 63 patients over period of 9 months. Patients who needed ankle or hind foot procedure were selected for trial. Patients were explained about the trial and popliteal block along with leaflets at preoperative clinics. Patients were randomized on the day of surgery. A sealed envelop stating whether patient will go to block group (A) or no block group (B) was opened in the anaesthetic room before the patient was anaesthetized. Patients were evaluated for subjective pain scores at 30 min, 6 hrs, 12 hrs and 24 hrs after surgery. Amount of anaelgesic required and time to first dose was documented. Popliteal blocks were given by one foot and ankle consultant and one trained fellow. The block was administered in lateral position at 0.8 mA stimulus to detect the nerve. The data was compared statistically between group A and B. Results. The average pain scores in Group A (33 pts) were 0.72, 1.60, 1.51 and 1.03 at 30 min, 6 hrs, 12 hrs and 24 hrs respectively. While in Group B (30 pts) it was 2.73, 5.5, 6.03 and 3.33 at 30 min, 6 hrs, 12 hrs and 24 hrs respectively. There was statistically significant difference in pain scores at 6 and 12 hrs. There was no statistically significant difference in pain scores at 30 min and 24 hrs. Time to the request for first analgesic was statistically longer in Group A. Conclusion. Popliteal block offers an effective way of pain relief in ankle and hind foot surgery. We believe that it may reduce amount of anaesthetic or anaelgesic drug requirement as well

Purpose of study. This RCT is to determine whether or not there is a clinical benefit from inserting a dynamic stabilising implant such as the Wallis ligament on the functional recovery of patients who have undergone lumbar decompression surgery. This Interspinous implant was developed as an anatomically conserving procedure without recourse to lumbar spinal fusion surgery. The biomechanical studies have shown that unloading the disc and facet joints reduces intradiscal pressures at same and adjacent levels. The aim of this study was to identify a patential Wallis affect. Methods. Ethicallly approved. Patients were randomized into 2 groups, decompression alone or decompression with wallis interspinous ligament stabilisation. Patients were assessed pre operatively and post operatively every 6 months by VAS pain score and Oswestry Disability Index. Summary of findings. A total of 60 patients were recriuted the study from October 2005. Equal number had been randomized into two groups. The mean age of 54 (24–85) and the average follow is 36 months (6–48). The results were significantly better in decompression plus Wallis group compared to decompression alone, showing a minimal clinical difference compared to the control group. Relationship between findings and existing knowledge: Our results deomonstrate that clincial outcomes are significantly better when a Wallis implant was used in lumbar deompression. Patients experienced less back pain. Overall significance of findings: The Wallis implant represents a successful non fusion stabilisation device in the treatment of degenerative lumbar spine disease with canal stenosis. Minimal soft tissue dissection, quick rehabilitation, low morbidity. The Wallis ligament sucessfully treats spinal stenosis by reducing pain score, preserving mobility, and function

Aims. Hip fractures pose a significant burden on the healthcare system. Hyperglycaemia and a state of Type 2 diabetes exists post operatively. Being normoglycaemic has well documented benefits. Pre operative carbohydrate loading has been shown to have two good effects. It decrease hyperglycaemia post operatively and allows the patient to undergo less strict fasting protocols. Insulin resistance to date has not been examined in these patients and this was determined using a validated formula (HOMA/IR). Methods. Three trauma hospitals were enrolled and patients with hip fractures requiring operative fixation were enlisted. Exclusion criteria: diabetic patients and inability to imbibe. 100 neck of femur fractures were examined. 46 patients were fasted normally. 32 test patients were given a carbohydrate rich drink pre operatively the night before surgery and in the morning up to 2 hours prior to surgery. 22 patients were excluded. Serum random glucose and insulin levels were taken on admission. Fasting serum glucose and insulin levels were taken on day one post operatively. Results. Control vs Trial average age: 82y and 75y. Admission glucose levels for Control vs Pre Op Loading: 6.5 vs 6.77 mmol/l. The average post operative Control vs Pre Op Loading: Glucose: 7.59 mmol/l vs 6.23mmol/. HOMA/IR in the control vs Pre Op loading group were: 1.86 and 1.2 compared to Post Op readings of 12 and 2. Paired T Test shows that there is significant decrease in hyperglycaemia and insulin resistance (p< 0.05). Conclusions. Pre operative carbohydrate loading leads to a decrease in hyperglycaemia and insulin resistance after surgery for hip fractures. Furthermore, patients are permitted a more liberal fasting regime leading to improved patient well being and less anxiety. The morbidity associated with a hyperglycaemic diabetic state is well documented and avoidance of this may lead to a decreased burden on the healthcare system

Previously, we conducted a multi-center, double-blinded randomized controlled trial comparing arthroscopic Bankart repair with and without remplissage. The end point for the randomized controlled trial was two years post-operative, providing support for the benefits of remplissage in the short term in reducing recurrent instability. The aim of this study was to compare the medium term (3 to 9 years) outcomes of patients previously randomized to have undergone isolated Bankart repair (NO REMP) or Bankart repair with remplissage (REMP) for the management of recurrent anterior glenohumeral instability. The rate of recurrent instability and instances of re-operation were examined. The original study was a double-blinded, randomized clinical trial with two 1:1 parallel groups with recruitment undertaken between 2011 and 2017. For this medium-term study, participants were reached for a telephone follow-up in 2020 and asked a series of standardized questions regarding ensuing instances of subluxation, dislocation or reoperation that had occurred on their shoulder for which they were randomized. Descriptive statistics were generated for all variables. “Failure” was defined as occurrence of a dislocation. “Recurrent instability” was defined as the participant reporting a dislocation or two or more occurences of subluxation greater than one year post-operative. All analyses were undertaken based on intention-to-treat whereby their data was analyzed based on the group to which they were originally allocated. One-hundred and eight participants were randomized of which 50 in the NO REMP group and 52 in the REMP group were included in the analyses in the original study. The mean number of months from surgery to final follow-up was 49.3 for the NO REMP group and 53.8 for the REMP group. The rates of re-dislocation or failure were 8% (4/52) in the REMP group at an average of 23.8 months post-operative versus 22% (11/50) in the NO REMP at an average of 16.5 months post-operative. The rates of recurrent instability were 10% (5/52) in the REMP group at an average of 24 months post-operative versus 30% (15/50) in the NO REMP group at an average of 19.5 months post-operative. Survival curves were significantly different favouring REMP in both scenarios. Arthroscopic Bankart repair combined with remplissage is an effective procedure in the treatment of patients with an engaging Hill-Sachs lesion and minimal glenoid bone loss (<15%). Patients can expect favourable rates of recurrent instability when compared with isolated Bankart repair at medium term follw-up

Aim. In 10% of the presumed aseptic hip or knee revisions, a low-grade infection is unexpectedly diagnosed based on the tissue samples taken during revision. Extended antimicrobial prophylaxis can possibly reduce the failure rate in cases of unexpected PJI, because the prophylaxis can be considered as early empiric treatment. In this randomized controlled study we analysed whether extended antimicrobial prophylaxis compared to a single dose is beneficial to improve the outcome of treatment in unexpected PJI in revision arthroplasty. Method. This study was nested in a randomized clinical trial comparing single-dose cefazolin with prolonged prophylaxis (15 doses of cefazolin over 5 days) for revision arthroplasty of the hip or knee. For this analysis, patients were included if an unsuspected PJI (defined as ≥2 positive intraoperative tissue samples with the same microorganism) was diagnosed. PJI treatment consisted of 12 weeks of a rifampicin-based regimen in Staphylococcal PJI, without removal of the prosthesis. We examined Infection characteristics and success of treatment after one year, defined as the absence of signs or treatment for PJI during follow-up. Results. After randomization of 662 patients, 68 unexpected PJI were diagnosed. In 5 cases no antimicrobial treatment was started. The success rate after one year follow-up for those who received PJI treatment was 96% (28/29) in the single dose group and 91% (31/34) in the extended prophylaxis group (p=1.00). The most frequently identified pathogens in unexpected PJI were Cutibacterium acnes (n=50) and Staphylococcus epidermidis (n=14). The causatives were susceptible for the cefazolin prophylaxis in 61 of the 63 cases. The interval between the stopped prophylaxis and the re-start of antimicrobial treatment was on average 10 days (SD 4) for the single dose and 5 days (SD 4) for the extended group. The mean duration of antimicrobial treatment was 83 days (SD 12) and did not differ between both groups (p=0.16). Conclusions. This is the first randomized controlled trial in which extended prophylaxis showed no benefit on the prosthesis survival for patients with an unexpected PJI after assumed aseptic revision of the hip or knee prosthesis. The results imply that extended prophylaxis should not be given as part of early empiric therapy

Aims. 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. Methods. 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. Results. No bias in treatment effect was observed overall for the CI site, or the first five sites, compared with the remaining sites in either trial. An early treatment effect on the OSS was observed for the first quintile of participants recruited to ProFHER only (clinically relevant difference of seven points). Selection bias for age was observed in the ProFHER trial only, with slightly younger patients being recruited into the study. Both trials showed some selection bias for markers of poor prognosis, although these did not appear to change over time. Conclusion. No bias in treatment effects overall were found at the CI or early sites set-up. An early treatment effect was found in one of the two trials, which was likely a chance effect as this did not continue during the study. Selection bias was observed in both RCTs, however this was minimal and did not impact on outcome. Cite this article: Bone Jt Open 2023;4(2):96–103

Novel immersive virtual reality (IVR) technologies are revolutionizing medical education. Virtual anatomy education using head-mounted displays allows users to interact with virtual anatomical objects, move within the virtual rooms, and interact with other virtual users. While IVR has been shown to be more effective than textbook learning and 3D computer models presented in 2D screens, the effectiveness of IVR compared to cadaveric models in anatomy education is currently unknown. In this study, we aim to compare the effectiveness of IVR with direct cadaveric bone models in teaching upper and lower limb anatomy for first-year medical students. A randomized, double-blind crossover non-inferiority trial was conducted. Participants were first-year medical students from a single University. Exclusion criteria included students who undertook prior undergraduate or graduate degrees in anatomy. In the first stage of the study, students were randomized in a 1:1 ratio to IVR or cadaveric bone groups studying upper limb skeletal anatomy. All students were then crossed over and used cadaveric bone or IVR to study lower limb skeletal anatomy. All students in both groups completed a pre-and post-intervention knowledge test. The educational content was based on the University of Toronto Medical Anatomy Curriculum. The Oculus Quest 2 Headsets (Meta Technologies) and PrecisionOS Anatomy application (PrecisionOS Technology) were utilized for the virtual reality component. The primary endpoint of the study was student performance on the pre-and post-intervention knowledge tests. We hypothesized that student performance in the IVR groups would be comparable to the cadaveric bone group. 50 first-year medical students met inclusion criteria and were computer randomized (1:1 ratio) to IVR and cadaveric bone group for upper limb skeletal anatomy education. Forty-six students attended the study, 21 completed the upper limb modules, and 19 completed the lower limb modules. Among all students, average score on the pre-intervention knowledge test was 14.6% (Standard Deviation (SD)=18.2%) and 25.0% (SD=17%) for upper and lower limbs, respectively. Percentage increase in students’ scores between pre-and post-intervention knowledge test, in the upper limb for IVR, was 15 % and 16.7% for cadaveric bones (p = 0. 2861), and for the lower limb score increase was 22.6% in the IVR and 22.5% in the cadaveric bone group (p = 0.9356). In this non-inferiority crossover randomized controlled trial, we found no significant difference between student performance in knowledge tests after using IVR or cadaveric bones. Immersive virtual reality and cadaveric bones were equally effective in skeletal anatomy education. Going forward, with advances in VR technologies and anatomy applications, we can expect to see further improvements in the effectiveness of these technologies in anatomy and surgical education. These findings have implications for medical schools having challenges in acquiring cadavers and cadaveric parts

Novel immersive virtual reality (IVR) technologies are revolutionizing medical education. Virtual anatomy education using head-mounted displays allows users to interact with virtual anatomical objects, move within the virtual rooms, and interact with other virtual users. While IVR has been shown to be more effective than textbook learning and 3D computer models presented in 2D screens, the effectiveness of IVR compared to cadaveric models in anatomy education is currently unknown. In this study, we aim to compare the effectiveness of IVR with direct cadaveric bone models in teaching upper and lower limb anatomy for first-year medical students. A randomized, double-blind crossover non-inferiority trial was conducted. Participants were first-year medical students from a single University. Exclusion criteria included students who undertook prior undergraduate or graduate degrees in anatomy. In the first stage of the study, students were randomized in a 1:1 ratio to IVR or cadaveric bone groups studying upper limb skeletal anatomy. All students were then crossed over and used cadaveric bone or IVR to study lower limb skeletal anatomy. All students in both groups completed a pre-and post-intervention knowledge test. The educational content was based on the University of Toronto Medical Anatomy Curriculum. The Oculus Quest 2 Headsets (Meta Technologies) and PrecisionOS Anatomy application (PrecisionOS Technology) were utilized for the virtual reality component. The primary endpoint of the study was student performance on the pre-and post-intervention knowledge tests. We hypothesized that student performance in the IVR groups would be comparable to the cadaveric bone group. 50 first-year medical students met inclusion criteria and were computer randomized (1:1 ratio) to IVR and cadaveric bone group for upper limb skeletal anatomy education. Forty-six students attended the study, 21 completed the upper limb modules, and 19 completed the lower limb modules. Among all students, average score on the pre-intervention knowledge test was 14.6% (Standard Deviation (SD)=18.2%) and 25.0% (SD=17%) for upper and lower limbs, respectively. Percentage increase in students’ scores between pre-and post-intervention knowledge test, in the upper limb for IVR, was 15 % and 16.7% for cadaveric bones (p = 0. 2861), and for the lower limb score increase was 22.6% in the IVR and 22.5% in the cadaveric bone group (p = 0.9356). In this non-inferiority crossover randomized controlled trial, we found no significant difference between student performance in knowledge tests after using IVR or cadaveric bones. Immersive virtual reality and cadaveric bones were equally effective in skeletal anatomy education. Going forward, with advances in VR technologies and anatomy applications, we can expect to see further improvements in the effectiveness of these technologies in anatomy and surgical education. These findings have implications for medical schools having challenges in acquiring cadavers and cadaveric parts

Aim. Periprosthetic joint infection (PJI) is a severe complication after total joint arthroplasty. To prevent PJI, strict infection prevention measures are followed in combination with surgical antibiotic prophylaxis (SAP). To date, scientific reports concerning the optimal duration of SAP in revision arthroplasty are scarce. The aim of this multicenter open-label, randomized controlled trial in the Netherlands, is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin to prevent PJI within the first year after revision arthroplasty of the hip and knee. Method. Included patients with an assumed aseptic hip or knee revision procedure received a single dose of 2 or 3 gram cefazolin preoperatively. Patients were randomly assigned in a 1:1 ratio to receive extended prophylaxis of cefazolin during 5 days postoperatively versus no prophylaxis after wound closure. Patients were excluded if evidence of PJI at revision. The primary endpoint was the incidence of PJI within one year after revision arthroplasty. PJI was defined according to the 2018 Philadelphia consensus criteria. With a sample size of 746 patients, an alpha of 5% and a power of 80%, superiority of the extended regimen would be shown if the lower boundary of the 95% confidence interval (CI) of the absolute between-group difference of the percentage of PJI is below −4%. Results. In total 751 patients were included for analysis: 379 in the single dose cefazolin group and 372 in the extended group. Within one year, PJI occurred in 2.6% (10/379) in the single dose group and 2.4% (9/372) in the extended group (risk difference, −0.2 percentage points; 95% CI, −2.5 to 2.0%), thus superiority was not shown. Adverse drug events were seen in 20 cases with extended and 7 cases with a single dose prophylaxis. Conclusions. Extended prophylaxis is not significantly superior to a single dose of cefazolin to prevent PJI within the first year after revision arthroplasty of the hip or knee. This is the first randomized controlled trail in which the duration of SAP in the selected group of patients undergoing revision arthroplasty was studied. Extending SAP after closure of the wound could increase the selection or induction of antimicrobial resistance, has an increased risk for adverse drug events, and is therefore not in line with the primary goal of antimicrobial stewardship, comprising optimizing clinical outcomes and ensuring cost-effective therapy while minimizing unintended consequences of antimicrobial use

Adequate visual clarity is paramount to performing arthroscopic shoulder surgery safely, efficiently, and effectively. The addition of epinephrine in irrigation fluid, and the intravenous or local administration of tranexamic acid (TXA) have independently been reported to decrease bleeding thereby improving the surgeon's visualization during arthroscopic shoulder procedures. No study has compared the effect of systemic administered TXA, epinephrine added in the irrigation fluid or the combination of both TXA and epinephrine on visual clarity during shoulder arthroscopy with a placebo group. The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine delivered by a pressure-controlled pump in improving arthroscopic shoulder visualization during arthroscopic procedures and whether using both TXA and epinephrine together has an additive effect in improving visualization. The design of the study was a double-blinded, randomized controlled trial with four 1:1:1:1 parallel groups conducted at one center. Patients aged ≥18 years undergoing arthroscopic shoulder procedures including rotator cuff repair, arthroscopic biceps tenotomy/tenodesis, distal clavicle excision, subacromial decompression and labral repair by five fellowship-trained upper extremity surgeons were randomized into one of four arms: Pressure pump-controlled regular saline irrigation fluid (control), epinephrine (1ml of 1:1000) mixed in irrigation fluid (EPI), 1g intravenous TXA (TXA), and epinephrine and TXA (EPI/TXA). Visualization was rated on a 4-point Likert scale every 15 minutes with 0 indicating ‘poor’ quality and 3 indicating ‘excellent’ quality. The primary outcome measure was the unweighted mean of these ratings. Secondary outcomes included mean arterial blood pressure (MAP), surgery duration, surgery complexity, and adverse events within the first postoperative week. One hundred and twenty-eight participants with a mean age (± SD) of 56 (± 11) years were randomized. Mean visualization quality for the control, TXA, EPI, and EPI/TXA groups were 2.1 (±0.40), 2.1 (±0.52), 2.6 (±0.37), 2.6 (±0.35), respectively. In a regression model with visual quality as the dependent variable, the presence/absence of EPI was the most significant predictor of visualization quality (R=0.525; p < 0 .001). TXA presence/absence had no effect, and there was no interaction between TXA and EPI. The addition of MAP and surgery duration strengthened the model (R=0.529; p < 0 .001). Increased MAP and surgery duration were both associated with decreased visualization quality. When surgery duration was controlled, surgery complexity was not a significant predictor of visualization quality. No adverse events were recorded in any of the groups. Intravenous administration of TXA is not an effective alternative to epinephrine in the irrigation fluid to improve visualization during routine arthroscopic shoulder surgeries although its application is safe. There is no additional improvement in visualization when TXA is used in combination with epinephrine beyond the effect of epinephrine alone

Adequate visual clarity is paramount to performing arthroscopic shoulder surgery safely, efficiently, and effectively. The addition of epinephrine in irrigation fluid, and the intravenous or local administration of tranexamic acid (TXA) have independently been reported to decrease bleeding thereby improving the surgeon's visualization during arthroscopic shoulder procedures. No study has compared the effect of systemic administered TXA, epinephrine added in the irrigation fluid or the combination of both TXA and epinephrine on visual clarity during shoulder arthroscopy with a placebo group. The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine delivered by a pressure-controlled pump in improving arthroscopic shoulder visualization during arthroscopic procedures and whether using both TXA and epinephrine together has an additive effect in improving visualization. The design of the study was a double-blinded, randomized controlled trial with four 1:1:1:1 parallel groups conducted at one center. Patients aged ≥18 years undergoing arthroscopic shoulder procedures including rotator cuff repair, arthroscopic biceps tenotomy/tenodesis, distal clavicle excision, subacromial decompression and labral repair by five fellowship-trained upper extremity surgeons were randomized into one of four arms: Pressure pump-controlled regular saline irrigation fluid (control), epinephrine (1ml of 1:1000) mixed in irrigation fluid (EPI), 1g intravenous TXA (TXA), and epinephrine and TXA (EPI/TXA). Visualization was rated on a 4-point Likert scale every 15 minutes with 0 indicating ‘poor’ quality and 3 indicating ‘excellent’ quality. The primary outcome measure was the unweighted mean of these ratings. Secondary outcomes included mean arterial blood pressure (MAP), surgery duration, surgery complexity, and adverse events within the first postoperative week. One hundred and twenty-eight participants with a mean age (± SD) of 56 (± 11) years were randomized. Mean visualization quality for the control, TXA, EPI, and EPI/TXA groups were 2.1 (±0.40), 2.1 (±0.52), 2.6 (±0.37), 2.6 (±0.35), respectively. In a regression model with visual quality as the dependent variable, the presence/absence of EPI was the most significant predictor of visualization quality (R=0.525; p < 0 .001). TXA presence/absence had no effect, and there was no interaction between TXA and EPI. The addition of MAP and surgery duration strengthened the model (R=0.529; p < 0 .001). Increased MAP and surgery duration were both associated with decreased visualization quality. When surgery duration was controlled, surgery complexity was not a significant predictor of visualization quality. No adverse events were recorded in any of the groups. Intravenous administration of TXA is not an effective alternative to epinephrine in the irrigation fluid to improve visualization during routine arthroscopic shoulder surgeries although its application is safe. There is no additional improvement in visualization when TXA is used in combination with epinephrine beyond the effect of epinephrine alone

Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all fractures. Presently, the standard treatment of isolated humeral diaphyseal fractures is nonoperative care using splints, braces, and slings. Recent data has questioned the effectiveness of this strategy in ensuring fracture healing and optimal patient function. The primary objective of this randomized controlled trial (RCT) was to assess whether operative treatment of humeral shaft fractures with a plate and screw construct provides a better functional outcome than nonoperative treatment. Secondary objectives compared union rates and both clinical and patient-reported outcomes. Eligible patients with an isolated, closed humeral diaphyseal fracture were randomized to either nonoperative care (initial sugar-tong splint, followed by functional coaptation brace) or open reduction and internal fixation (ORIF; plate and screw construct). The primary outcome measure was the Disability Shoulder, Arm, Hand (DASH) score assessed at 2-, 6-, 16-, 24-, and 52-weeks. Secondary outcomes included the Short Musculoskeletal Functional Assessment (SMFA), the Constant Shoulder Score, range of motion (ROM), and radiographic parameters. Independent samples t-tests and Chi-squared analyses were used to compare treatment groups. The DASH, SMFA, and Constant Score were modelled over time using a multiple variable mixed effects model. A total of 180 patients were randomized, with 168 included in the final analysis. There were 84 patients treated nonoperatively and 84 treated with ORIF. There was no significant difference between the two treatment groups for age (mean = 45.4 years, SD 16.5 for nonoperative group and 41.7, SD 17.2 years for ORIF group; p=0.16), sex (38.1% female in nonoperative group and 39.3% female in ORIF group; p=0.87), body mass index (mean = 27.8, SD 8.7 for nonoperative group and 27.2, SD 6.2 for ORIF group; p=0.64), or smoking status (p=0.74). There was a significant improvement in the DASH scores at 6 weeks in the ORIF group compared to the nonoperative group (mean=33.8, SD 21.2 in the ORIF group vs. mean=56.5, SD=21.1 in the nonoperative group; p < 0 .0001). At 4 months, the DASH scores were also significantly better in the ORIF group (mean=21.6, SD=19.7 in the ORIF group vs. mean=31.6, SD=24.6 in the nonoperative group; p=0.009. However, there was no difference in DASH scores at 12-month follow-up between the groups (mean=8.8,SD=10.9 vs. mean=11.0, SD=16.9 in the nonoperative group; p=0.39). Males had improved DASH scores at all timepoints compared with females. There was significantly quicker time to union (p=0.016) and improved position (p < 0 .001) in the ORIF group. There were 13 (15.5%) nonunions in the nonoperative group and four (4.7%) combined superficial and deep infections in the ORIF group. There were seven radial nerve palsies in the nonoperative group and five (a single iatrogenic) radial nerve palsies in the ORIF group. This large RCT comparing operative and nonoperative treatment of humeral diaphyseal fractures found significantly improved functional outcome scores in patients treated surgically at 6 weeks and 4 months. However, the early functional improvement did not persist at the 12-month follow-up. There was a 15.5% nonunion rate, which required surgical intervention, in the nonoperative group and a similar radial nerve palsy rate between groups

Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all fractures. Presently, the standard treatment of isolated humeral diaphyseal fractures is nonoperative care using splints, braces, and slings. Recent data has questioned the effectiveness of this strategy in ensuring fracture healing and optimal patient function. The primary objective of this randomized controlled trial (RCT) was to assess whether operative treatment of humeral shaft fractures with a plate and screw construct provides a better functional outcome than nonoperative treatment. Secondary objectives compared union rates and both clinical and patient-reported outcomes. Eligible patients with an isolated, closed humeral diaphyseal fracture were randomized to either nonoperative care (initial sugar-tong splint, followed by functional coaptation brace) or open reduction and internal fixation (ORIF; plate and screw construct). The primary outcome measure was the Disability Shoulder, Arm, Hand (DASH) score assessed at 2-, 6-, 16-, 24-, and 52-weeks. Secondary outcomes included the Short Musculoskeletal Functional Assessment (SMFA), the Constant Shoulder Score, range of motion (ROM), and radiographic parameters. Independent samples t-tests and Chi-squared analyses were used to compare treatment groups. The DASH, SMFA, and Constant Score were modelled over time using a multiple variable mixed effects model. A total of 180 patients were randomized, with 168 included in the final analysis. There were 84 patients treated nonoperatively and 84 treated with ORIF. There was no significant difference between the two treatment groups for age (mean = 45.4 years, SD 16.5 for nonoperative group and 41.7, SD 17.2 years for ORIF group; p=0.16), sex (38.1% female in nonoperative group and 39.3% female in ORIF group; p=0.87), body mass index (mean = 27.8, SD 8.7 for nonoperative group and 27.2, SD 6.2 for ORIF group; p=0.64), or smoking status (p=0.74). There was a significant improvement in the DASH scores at 6 weeks in the ORIF group compared to the nonoperative group (mean=33.8, SD 21.2 in the ORIF group vs. mean=56.5, SD=21.1 in the nonoperative group; p < 0 .0001). At 4 months, the DASH scores were also significantly better in the ORIF group (mean=21.6, SD=19.7 in the ORIF group vs. mean=31.6, SD=24.6 in the nonoperative group; p=0.009. However, there was no difference in DASH scores at 12-month follow-up between the groups (mean=8.8,SD=10.9 vs. mean=11.0, SD=16.9 in the nonoperative group; p=0.39). Males had improved DASH scores at all timepoints compared with females. There was significantly quicker time to union (p=0.016) and improved position (p < 0 .001) in the ORIF group. There were 13 (15.5%) nonunions in the nonoperative group and four (4.7%) combined superficial and deep infections in the ORIF group. There were seven radial nerve palsies in the nonoperative group and five (a single iatrogenic) radial nerve palsies in the ORIF group. This large RCT comparing operative and nonoperative treatment of humeral diaphyseal fractures found significantly improved functional outcome scores in patients treated surgically at 6 weeks and 4 months. However, the early functional improvement did not persist at the 12-month follow-up. There was a 15.5% nonunion rate, which required surgical intervention, in the nonoperative group and a similar radial nerve palsy rate between groups

This randomized controlled study aimed to compare surgical duration, intra-operative blood loss, and fluoroscopy time between the suprapatellar and infrapatellar approaches for intramedullary interlocking nailing of tibia. We included 40 adult patients with tibial shaft fractures, excluding those with non-union, revision surgery, or polytrauma. Patients were divided equally into two groups using block randomization: Group A (20 patients) underwent the infrapatellar approach, and Group B (20 patients) underwent the suprapatellar approach. Blood loss was measured using gravimetric method and by changes in pre-operative and post operative haemoglobin levels. Surgical duration was estimated by calculating the time elapsed between the start and end of the procedure and fluoroscopy time was logged from the fluoroscopy machine. In group A, blood loss averaged 154±30.98ml, slightly more than in group B (150±32.92ml), though the difference was not statistically significant (p>0.05). Group A also showed a higher difference in haemoglobin levels (2.20±1.13 gm/dl) compared to group B (1.15±0.93 gm/dl), which was statistically significant (p=0.02). Fluoroscopy time and surgery duration were slightly longer in group A compared to group B but not statistically significant(p=0.693). The suprapatellar approach results in lesser blood loss, potentially promoting faster recovery, reduced need for blood transfusions and shorter hospital stays. It also entails shorter fluoroscopy time and surgical duration (though not statistically significant) which may reduce radiation exposure for the surgical team

Background. Digital injuries are among the most common presentations to the emergency department. In order to sufficiently examine and manage these injuries, adequate, prompt, and predictable anaesthesia is essential. In this trial, we aim to primarily compare the degree of pain and anaesthesia onset time between the two-injection dorsal block technique (TD) and the single-injection volar subcutaneous block technique (SV). Further, we describe the temporal and anatomical effects of both techniques for an accurate delineation of the anesthetized regions. Methods. A single-centre prospective randomized controlled trial involving patients presenting with isolated wounds to the fingers requiring primary repair under local anaesthesia. Patients were randomized to either the SV or TD blocks. The primary outcome was procedure-related pain (Numerical Rating Scale). Further, we assessed the extent of anaesthesia along with the anaesthesia onset time. Results. A total of 100 patients were included in the final analysis, 50 on each arm of the study. The median pain score during injection was significantly higher in patients who received TD block than patients who received SV block (median [interquartile range] = 4 [2.25, 5] vs. 3 [2, 4], respectively, P = 0.006). However, anaesthesia onset time was not statistically different among the groups (P = 0.39). The extent of anaesthesia was more predictable in the dorsal block compared to the volar block. Conclusion. The single-injection volar subcutaneous blocks are less painful with a similar anaesthesia onset time. Injuries presenting in the proximal dorsal region may benefit from the two-injection dorsal blocks, given the anatomical differences and timely anaesthesia of the region

Our primary objective was to compare healing rates in patients undergoing arthroscopic rotator cuff repair for degenerative tears, with and without bone channeling. Our secondary objectives were to compare disease-specific quality of life and patient reported outcomes as measured by the Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score and Constant score between groups. Patients undergoing arthroscopic rotator cuff repair at three sites were randomized to receive either bone channeling augmentation or standard repair. Healing rates were determined by ultrasound at 6 and 24 months post operatively. WORC, ASES, and Constant scores were compared between groups at baseline and at 3, 6, 12 and 24 months post operatively. One hundred sixty-eight patients were recruited and randomized between 2013 to 2018. Statistically significant improvements occurred in both groups from pre-operative to all time points in all clinical outcome scores (p < 0 .0001). Intention to treat analysis revealed no statistical differences in healing rates between the two interventions at 24 months post-operative. No differences were observed in WORC, ASES or Constant scores at any time-point. This trial did not demonstrate superiority of intra-operative bone channeling in rotator cuff repair surgery at 24 months post-operative. Healing rates and patient-reported function and quality of life measures were similar between groups

Distal radius fractures (DRF) are common and the indication for surgical treatment remain controversial in patients higher than 60 years old. The purpose of the study was to review and analyze the current evidence-based literature. We performed a systematic review and meta-analysis according to PRISMA guidelines in order to evaluate the efficacy of volar locking plating (VLP) and conservative treatment in DRF in patients over 60 years old. Electronic databases including MEDLINE, CENTRAL, Embase, Web of science and Clinical Trial.gov were searched from inception to October 2020 for randomized controlled trials. Relevant article reference lists were also passed over. Two reviewers independently screened and extracted the data. Main outcomes included functional status: wrist range of motion, validated scores and grip strength. Secondary outcomes include post-operative complications and radiologic assessment. From 3009 screened citations, 5 trials (539 patients) met the inclusion criteria. All trials of this random effect meta-analysis were at moderate risk of bias due to lack of blinding. Differences in the DASH score (MD −5,91; 95% CI, −8,83; −3,00), PRWE score (MD −9.07; 95% CI, −14.57, −3.57) and grip strength (MD 5,12; 95% CI, 0,59-9,65) were statistically significant and favored VLPs. No effect was observed in terms of range of motion. Adverse events are frequent in both treatment groups, reoperation rate is higher in the VLP group. VLP may provide better functional outcomes in patients higher than 60 years old. More RCT are still needed to evaluate if the risks and complications of VLP outweigh the benefits

Distal radius fractures (DRF) are common and the indication for surgical treatment remain controversial in patients higher than 60 years old. The purpose of the study was to review and analyze the current evidence-based literature. We performed a systematic review and meta-analysis according to PRISMA guidelines in order to evaluate the efficacy of volar locking plating (VLP) and conservative treatment in DRF in patients over 60 years old. Electronic databases including MEDLINE, CENTRAL, Embase, Web of science and Clinical Trial.gov were searched from inception to October 2020 for randomized controlled trials. Relevant article reference lists were also passed over. Two reviewers independently screened and extracted the data. Main outcomes included functional status: wrist range of motion, validated scores and grip strength. Secondary outcomes include post-operative complications and radiologic assessment. From 3009 screened citations, 5 trials (539 patients) met the inclusion criteria. All trials of this random effect meta-analysis were at moderate risk of bias due to lack of blinding. Differences in the DASH score (MD −5,91; 95% CI, −8,83; −3,00), PRWE score (MD −9.07; 95% CI, −14.57, −3.57) and grip strength (MD 5,12; 95% CI, 0,59-9,65) were statistically significant and favored VLPs. No effect was observed in terms of range of motion. Adverse events are frequent in both treatment groups, reoperation rate is higher in the VLP group. VLP may provide better functional outcomes in patients higher than 60 years old. More RCT are still needed to evaluate if the risks and complications of VLP outweigh the benefits