Background

Chronic back pain (CBP) is a major cause of disability globally and its causes are multifactorial. Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) are human herpes viruses usually acquired in early life. About 50% and over 90% of the population worldwide have been infected with CMV and EBV, respectively. This study investigated a potential causal relationship between CMV infection and CBP.

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.

Aims. Mendelian randomization (MR) is considered to overcome the bias of observational studies, but there is no current meta-analysis of MR studies on rheumatoid arthritis (RA). The purpose of this study was to summarize the relationship between potential pathogenic factors and RA risk based on existing MR studies. Methods. PubMed, Web of Science, and Embase were searched for MR studies on influencing factors in relation to RA up to October 2022. Meta-analyses of MR studies assessing correlations between various potential pathogenic factors and RA were conducted. Random-effect and fixed-effect models were used to synthesize the odds ratios of various pathogenic factors and RA. The quality of the study was assessed using the Strengthening the Reporting of Observational Studies in Epidemiology using Mendelian Randomization (STROBE-MR) guidelines. Results. A total of 517 potentially relevant articles were screened, 35 studies were included in the systematic review, and 19 studies were eligible to be included in the meta-analysis. Pooled estimates of 19 included studies (causality between 15 different risk factors and RA) revealed that obesity, smoking, coffee intake, lower education attainment, and Graves’ disease (GD) were related to the increased risk of RA. In contrast, the causality contribution from serum mineral levels (calcium, iron, copper, zinc, magnesium, selenium), alcohol intake, and chronic periodontitis to RA is not significant. Conclusion. Obesity, smoking, education attainment, and GD have real causal effects on the occurrence and development of RA. These results may provide insights into the genetic susceptibility and potential biological pathways of RA. Cite this article: Bone Joint Res 2023;12(9):601–614

Aims. Nearly 99,000 total knee arthroplasties (TKAs) are performed in UK annually. Despite plenty of research, the satisfaction rate of this surgery is around 80%. One of the important intraoperative factors affecting the outcome is alignment. The relationship between joint obliquity and functional outcomes is not well understood. Therefore, a study is required to investigate and compare the effects of two types of alignment (mechanical and kinematic) on functional outcomes and range of motion. Methods. The aim of the study is to compare navigated kinematically aligned TKAs (KA TKAs) with navigated mechanically aligned TKA (MA TKA) in terms of function and ROM. We aim to recruit a total of 96 patients in the trial. The patients will be recruited from clinics of various consultants working in the trust after screening them for eligibility criteria and obtaining their informed consent to participate in this study. Randomization will be done prior to surgery by a software. The primary outcome measure will be the Knee injury and Osteoarthritis Outcome Score The secondary outcome measures include Oxford Knee Score, ROM, EuroQol five-dimension questionnaire, EuroQol visual analogue scale, 12-Item Short-Form Health Survey (SF-12), and Forgotten Joint Score. The scores will be calculated preoperatively and then at six weeks, six months, and one year after surgery. The scores will undergo a statistical analysis. Discussion. There is no clear evidence on the best alignment for a knee arthroplasty. This randomized controlled trial will test the null hypothesis that navigated KA TKAs do not perform better than navigated MA TKAs. Cite this article: Bone Jt Open 2021;2(11):945–950

Aims. Paediatric fractures are highly prevalent and are most often treated with plaster. The application and removal of plaster is often an anxiety-inducing experience for children. Decreasing the anxiety level may improve the patients’ satisfaction and the quality of healthcare. Virtual reality (VR) has proven to effectively distract children and reduce their anxiety in other clinical settings, and it seems to have a similar effect during plaster treatment. This study aims to further investigate the effect of VR on the anxiety level of children with fractures who undergo plaster removal or replacement in the plaster room. Methods. A randomized controlled trial was conducted. A total of 255 patients were included, aged five to 17 years, who needed plaster treatment for a fracture of the upper or lower limb. Randomization was stratified for age (five to 11 and 12 to 17 years). The intervention group was distracted with VR goggles and headphones during the plaster treatment, whereas the control group received standard care. As the primary outcome, the post-procedural level of anxiety was measured with the Child Fear Scale (CFS). Secondary outcomes included the children’s anxiety reduction (difference between CFS after and CFS before plaster procedure), numerical rating scale (NRS) pain, NRS satisfaction of the children and accompanying parents/guardians, and the children’s heart rates during the procedure. An independent-samples t-test and Mann-Whitney U test (depending on the data distribution) were used to analyze the data. Results. The post-procedural CFS was significantly lower (p < 0.001) in the intervention group (proportion of children with no anxiety = 78.6%) than in the control group (56.8%). The anxiety reduction, NRS pain and satisfaction scores, and heart rates showed no significant differences between the control group and the intervention group. Subanalyses showed an increased effect of VR on anxiety levels in young patients, females, upper limb fractures, and those who had had previous plaster treatment. Conclusion. VR effectively reduces the anxiety levels of children in the plaster room, especially in young girls. No statistically significant effects were seen regarding pain, heart rate, or satisfaction scores. Cite this article: Bone Joint J 2024;106-B(7):728–734

Despite total knee arthroplasty demonstrating high levels of success, 20% of patients report dissatisfaction with their result. Wellness Stasis Socks are embedded with a proprietary pattern of neuro-receptor activation points that have been proven to activate a precise neuro-response, as according to the pattern theory of haptic perception, which stimulates improvements in pain and function. Technologies that manipulate this sensory environment, such as textured insoles, have proven to be effective in improving gait patterns in patients with knee osteoarthritis. In regard to patients undergoing TKA using this new technology may prove beneficial as an adjunct to recovery as many patients suffer from further deficits to their proprioceptive system caused by ligamentous damage and alterations to mechanoreceptors during procedure. We hypothesized that the Wellness Stasis Socks are a safe, cost-effective and easily scalable strategy to support TKA patients through their recovery. Double-blinded, placebo-controlled randomized trial. Randomization using a computer-generated program . All study coordinators, healthcare personel and patients were blinded to patient groups. All surgical procedures were conducted by the same technique and orthopaedic surgeon. Intervention group: Wellness Stasis socks containing receptor point-activation technology. Control group: indentical appearing Wellness Stasis socks without receptor point-activation technology. Sock use during the waking hours . All additional post-operative protocols remained consistent between groups including same facility physiotherapy . Additional modalities (ice machines, soft-tissue massages, acupuncture) were prohibited. WOMAC questionnaire completed at baseline, 2 weeks, and 6 weeks to assess pain, stiffness and physical function. G. *. Power software to determine minimum sample of 50 in each group. No patients were lost to follow up and all followed study protocol. Data analysis using SPSS software. P-values, effect sizes, and confidence intervals are reported to assess clinical relevance of the finding. Physical status classifications were compared using t-test. Within-subject and between-subject differences in the mean WOMAC were analyzed by ANOVA. Cramer's V statistical analysis noted that other variables of Sex, BMI, ASA classification and Age were not statistically different between the control and intervention groups. No statistical difference between groups in Preop Womac scores. The data showed a consistent improvement in Womac scores for pain and stiffness at 2 weeks post op in the interventional group over the control group. The womac scores assessing physical function showed a consistent improvement at both 2 and 6 weeks post op in the intervention group compared to the control group. There were no complications in either group associated the sock use. The intervention proved to be a low cost and safe additional intervention post operatively from TKA to help patients improve with regard to pain, stiffness and physical function. This study suggests this modality can be added to the list of other commonly used post op interventions such as cryocuffs, physiotherapy, and relaxation techniques as safe post op interventions to help patients improve post op TKA and can act as an adjunct in providing non narcotic pain control

Introduction: Hip Simulator studies show that use of highly cross-linked polyethylene in total hip replacement reduces polyethylene (PE) wear by a factor of 85–98%. Early clinical studies using RSA or computer-aided techniques of polyethylene wear measurement show a reduction of 50–80%. There is speculation about why this discrepancy in the clinical and laboratory data should exist. The results of a randomized, prospective double blinded (surgeon and patient) trial (RCT) of cross-linked versus conventional polyethylene, using a 100% reproducible method of PE wear measurement, are reported. Materials And Methods: After Ethics Committee approval, the two authors enrolled 124 patients onto an RCT comparing Enduron (non cross-linked PE) and highly cross-linked Marathon PE (DePuy, Leeds, UK). Randomization was performed by the circulating nurse intra-operatively opening an envelope which determined whether the patient received an Enduron or Marathon liner appropriate to the size of the metal shell. Liners were implanted into identical metal shells (Duraloc 300) with one screw. They articulated with identical 28mm CoCr femoral heads and cemented Charnley Elite femoral stems. All patients were followed with anteroposterior and lateral radiographs at 3 days, 6 weeks, 3 months 6 months, 1, 2, 3 and 4 years. PE wear was measured with PWAuto, a validated computer-assisted technique with 100% reproducibility and accuracy of ±0.13mm. Results: One hundred and thirteen patients had appropriate radiographs and follow-up interval. Mean follow-up was 2.6 years (range 2–4 years). Fifty-eight patients received Enduron liners and 55 patients received Marathon liners. At 6 months (E=0.32, M=0.31mm) and one year (E=0.37, M=0.31mm) the three-dimensional PE wear was identical in both groups. Thereafter, all PE wear measurements showed a significant difference in PE wear between the two groups. Wear of the conventional Enduron group continued (0.51mm at 2 years, 0.70 at 3 years, 0.97 at 4 years), while the crosslinked Marathon group showed virtually no further wear (0.32mm at 2 years, 0.32mm at 3 years, 0.33mm at 4 years). Conclusions: This is the first study to confirm that Hip Simulator predictions of cross-linked PE wear can be reproduced in-vivo. Randomization, double-blinding, and the use of a 100% reproducible technique for wear measurement add further weight to this data

Background. The purpose of this multicenter, randomized clinical trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss for revision total hip arthroplasty (THA). Methods. Six centers prospectively randomized 155 revisions to one of four regimens: 1g of intravenous (IV) TXA prior to incision, a double dose regimen of 1g IV TXA prior to incision and 1g IV TXA during wound closure, a combination of 1g IV TXA prior to incision and 1g intraoperative topical TXA, or three doses of 1950mg oral TXA administered 2 hours preoperatively, 6 hours postoperatively, and on the morning of postoperative day one. Randomization was based upon revision subgroups to ensure equivalent group distribution, including: femur only, acetabulum only, both component, explant/spacer, and second stage reimplantation. Patients undergoing an isolated modular exchange were excluded. An a priori power analysis (alpha = 0.05; beta = 0.80) determined 40 patients per group were required to identify a 1g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher's exact tests, and two one-sided t-tests for equivalence. Results. Demographic and surgical variables were equivalent between groups. No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (single IV = 3.6 g/dL, double IV = 3.6 g/dL, combined = 3.4 g/dL, and oral = 3.6 g/dL; p = 0.87), calculated blood loss (p = 0.67), or transfusion rates (single IV = 14%, double IV = 20%, combined = 17%, oral = 21%; p = 0.85). Equivalence testing revealed all possible pairings were statistically equivalent, assuming greater than a 1g/dL difference in hemoglobin reduction as clinically relevant. Conclusions. All TXA regimens tested had equivalent blood-sparing properties in the setting of revision THA. Surgeons should consider the lowest effective dose and the most economical regimen. For any tables or figures, please contact the authors directly

Introduction. Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA that is associated with greater blood loss. The purpose of this multi-center randomized trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA. Methods. 233 Septic and aseptic revision TKA from six-centers were randomized to either receive 1g pre-incision intravenous (IV) TXA, 1g pre- and post-incision IV TXA, 1g pre-incision IV and 1g intra-operative topical TXA, or three doses of 1950mg oral TXA given 2 hours pre-operatively, 6 hours post-operatively, and the morning of postoperative day 1. Randomization was performed based on type of revision to ensure equivalent distribution among groups. The primary outcome was reduction in hemoglobin. Power analysis determined 40 patients per group were necessary to identify a 1g/dL difference with an alpha of 0.05 and beta of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence. Results. One patient withdrew, 3 didn't undergo surgery, 16 were screen failures, and 17 did not receive the assigned treatment, leaving 196 patients for the analysis. There was no significant difference in reduction in hemoglobin amongst treatment groups (2.88g/dL for oral TXA, 2.79g/dL for single-dose IV TXA, 2.59g/dL for combined IV/topical TXA, and 2.58g/dL for double-dose IV TXA; p=0.48). Similarly, calculated blood loss (p=0.63) and transfusions (p=0.78) were not significantly different between groups. Finally, equivalence testing assuming a 1g/dL difference in hemoglobin change as clinically relevant showed all possible pairings were statistically equivalent. Conclusions. Despite the higher risk of blood loss in revision TKA, all TXA regimens tested had equivalent blood-sparing properties. Surgeons should consider using the lowest effective dose and the least costly regimen for TXA use in revision TKA

Aims

During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

Aims

Ankle fracture fixation is commonly performed by junior trainees. Simulation training using cadavers may shorten the learning curve and result in a technically superior surgical performance.

Aims

Olecranon fractures are usually caused by falling directly on to the olecranon or following a fall on to an outstretched arm. Displaced fractures of the olecranon with a stable ulnohumeral joint are commonly managed by open reduction and internal fixation. The current predominant method of management of simple displaced fractures with ulnohumeral stability (Mayo grade IIA) in the UK and internationally is a low-cost technique using tension band wiring. Suture or suture anchor techniques have been described with the aim of reducing the hardware related complications and reoperation. An all-suture technique has been developed to fix the fracture using strong synthetic sutures alone. The aim of this trial is to investigate the clinical and cost-effectiveness of tension suture repair versus traditional tension band wiring for the surgical fixation of Mayo grade IIA fractures of the olecranon.

Aims

Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data.

Aims

Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures.

Aims

Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization.

Aims

The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy.

Aims

Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures.

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Aims

The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children’s Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children’s Elbows (SCIENCE) trial.

Aims

To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture.