Cite this article:
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. Cite this article:
To develop a decision aid - Decision Support Package (DSP) - that will provide low back pain (LBP) patients, and their treating physiotherapists with information on the treatment options available to the patients To develop a training package for physiotherapists on how to use the DSP To encourage and evaluate the informed shared decision making (ISDM) process between patients and physiotherapists during consultation. We developed a DSP informed by existing research and collaboration with physiotherapists, patients and experts in the field of decision aids and LBP. We did six pieces of exploratory work: literature review; 2009 NICE LBP guidelines review; qualitative screening of transcripts of interviews of LBP patients; focus groups (patients); nominal group (physiotherapists), and Delphi study (experts). We collated these data to develop the DSP. We also developed a training package for physiotherapists.Aims
Method
Total hip replacement is an established surgical procedure done to alleviate hip pain due to joint diseases. However, this procedure is avoided in yonger patients with higher functional demands due to the potential for early failure. An ideal prosthesis will have have a high endurance against impact loading, with minimal micromotion at the bone cement interface, and a reduced risk of fatigue failure, with a favourable stress distribution pattern in the femur. We study the effect of varying the material properties and design element in a standard cemented total hip using Finite Element Analysis. A patient-specific 3D model of femur will be constructed from CT scan data, while a Summit® Cemented Hip System (Introduction
Methods
Allogeneic blood transfusion is associated with many complications and significant cost. The RD&E has looked at the use of autologous drains after our study of 100 cases showed an improved post-operative haemoglobin and reduced length of stay. There is a need to identify those patients of increased need for an autologous drain, in order to decrease the frequency of allogeneic transfusion. In 2007 a protocol was drawn up using information from our study of 191 cases which showed an average haemoglobin drop post-operatively of 3.05g/dl and average intra-operative blood loss of 285 ml. This protocol gives the surgeon triggers for autologous drain use; preoperative haemoglobin of <13g/dl, intra-operative blood loss of >400ml, tourniquet use, patient weight <50kg and patients refusing donated blood. In 2007-08, 65% of a further 275 cases analysed met the triggers for use of an autologous system. The remaining patients received low vacuum drains. Of the 275 patients, only 2 (<1%) of those who did not fulfil the criteria for an autologous drain required allogeneic blood, compared with 43 patients (24%) of those deemed high risk of transfusion, and assigned autologous drains. The protocol was therefore deemed to be successful in identifying those patients who required additional support and expenditure to minimise allogeneic blood transfusion. Analysis of this data led to recommended changes to the protocol in order to maximise the efficiency of the autologous drain use. In 2010 a further patient cohort studied showed a reduction in allogeneic blood transfusion to <10% of those receiving autologous drains, and an increase to 5% of those with low vacuum drains. Due to the increased cost of autologous drains (£68) compared with the low vacuum systems (£32), and the cost of allogeneic units at £141, the expenditure per patient was calculated and shown to fall from £92 in 2007 to £78 in the 2010. In conclusion, this protocol allows the clinician to appropriately target the use of the more expensive autologous drains to those of increased risk of transfusion. This protocol helps to minimise unnecessary allogeneic blood transfusion risks, and this has been shown to be more cost effective.
Allogeneic blood transfusion is associated with complications and significant cost. The RD&E has looked at the use of autologous drains to decrease the frequency of allogeneic transfusion after our study of 100 cases showed an improved post-operative haemoglobin and reduced length of stay. In 2007 a protocol to identify those patients of increased need for an autologous drain was made using a study of 191 cases showed an average haemoglobin drop post-operatively of 3.05g/dl and average intra-operative blood loss of 285 ml. This protocol gave triggers for autologous drain use; preoperative haemoglobin of <13g/dl, intra-operative blood loss >400ml, tourniquet use, patient weight <50kg and patients refusing donated blood. In 2007-08, 65% of a further 275 cases analysed met the triggers for use of an autologous system. The remaining patients received low vacuum drains. Of the 275 patients, only 2 (<1%) of those who did not fulfil the criteria for an autologous drain required allogeneic blood, compared with 43 patients (24%) of those deemed high risk of transfusion, and assigned autologous drains. The protocol was successful in identifying those patients who required additional support and expenditure to minimise allogeneic blood transfusion. Analysis of this data led to recommended changes to the protocol in order to maximise the efficiency of the autologous drain use. Due to the increased cost of autologous drains (£68) compared with the low vacuum systems (£32), and the cost of allogeneic units at £141, the expenditure per patient was calculated and shown to fall from £92 in 2007 to £78 in a further patient cohort in 2010. In conclusion, this protocol allows the clinician to appropriately target the use of the more expensive autologous drains to those of increased risk of transfusion. This helps to minimise unnecessary allogeneic transfusion, and this has been shown to be cost effective.
Abstract. Introduction. Component mal-positioning in total hip replacement (THR) and total knee replacement (TKR) can increase the risk of revision for various reasons. Compared to conventional surgery, relatively improved accuracy of implant positioning can be achieved using computer assisted technologies including navigation, patient-specific jigs, and robotic systems. However, it is not known whether application of these technologies has improved prosthesis survival in the real-world. This study aimed to compare risk of revision for all-causes following primary THR and TKR, and revision for dislocation following primary THR performed using computer assisted technologies compared to conventional technique. Methods. We performed an observational study using National Joint Registry data. All adult patients undergoing primary THR and TKR for osteoarthritis between 01/04/2003 to 31/12/2020 were eligible. Patients who received metal-on-metal bearing THR were excluded. We generated propensity score weights, using Sturmer weight trimming, based on: age, gender, ASA grade, side, operation funding, year of surgery, approach, and fixation. Specific additional variables included position and bearing for THR and patellar resurfacing for TKR. For THR, effective sample sizes and duration of follow up for conventional versus computer-guided and robotic-assisted analyses were 9,379 and 10,600 procedures, and approximately 18 and 4 years, respectively. For TKR, effective sample sizes and durations of follow up for conventional versus computer-guided, patient-specific jigs, and robotic-assisted groups were 92,579 procedures over 18 years, 11,665 procedures over 8 years, and 644 procedures over 3 years, respectively. Outcomes were assessed using Kaplan-Meier analysis and expressed using hazard ratios (HR) and 95% confidence intervals (CI). Results. For THR, analysis comparing computer-guided versus conventional technique demonstrated HR of 0.771 (95%CI 0.573–1.036) p=0.085, and 0.594 (95%CI 0.297–1.190) p=0.142, for revision for all-causes and dislocation, respectively. When comparing robotic-assisted versus conventional technique, HR for revision for all-causes was 0.480 (95%CI 0.067 –3.452) p=0.466. For TKR, compared to conventional surgery, HR for all-cause revision for procedures performed using computer guidance and patient-specific jigs were 0.967 (95% CI 0.888–1.052) p=0.430, and 0.937 (95% CI 0.708–1.241) p=0.65, respectively. HR for analysis comparing robotic-assisted versus conventional technique was 2.0940 (0.2423, 18.0995) p = 0.50. Conclusions. This is the largest study investigating this topic utilising propensity score analysis methods. We did not find a statistically significant difference in revision for all-causes and dislocation although these analyses are underpowered to detect smaller differences in effect size between groups. Additional comparison for revision for dislocation between robotic-assisted versus conventionally performed THR was not performed as this is a subset of revision for all-causes and wide confidence intervals were already observed for that analysis. It is also important to mention this NJR analysis study is of an observational
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). Methods. UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed
Aims. Periprosthetic fractures (PPFs) following hip arthroplasty are complex injuries. This study evaluates patient demographic characteristics, management, outcomes, and risk factors associated with PPF subtypes over a decade. Methods. Using a multicentre collaborative
Aims. Periprosthetic joint infection (PJI) demonstrates the most feared complication after total joint replacement (TJR). The current work analyzes the demographic, comorbidity, and complication profiles of all patients who had in-hospital treatment due to PJI. Furthermore, it aims to evaluate the in-hospital mortality of patients with PJI and analyze possible risk factors in terms of secondary diagnosis, diagnostic procedures, and complications. Methods. In a retrospective, cross-sectional
Aims. To map literature on prognostic factors related to outcomes of revision total knee arthroplasty (rTKA), to identify extensively studied factors and to guide future research into what domains need further exploration. Methods. We performed a systematic literature search in MEDLINE, Embase, and Web of Science. The search string included multiple synonyms of the following keywords: "revision TKA", "outcome" and "prognostic factor". We searched for studies assessing the association between at least one prognostic factor and at least one outcome measure after rTKA surgery. Data on sample size,
Abstract. Background. Oxidized zirconium (OxZr) has been introduced as an alternative bearing for femoral components in Total Knee Arthroplasty (TKA). It has a ceramic-like zirconium oxide outer layer with a low coefficient of friction. Early studies have found OxZr TKA to have a low incidence of early failure in young high demand patients. Currently no study has reported on the outcome of these implants beyond ten years. Objectives. The purpose of our study was to present an in-depth 15-year survival analysis of cemented Profix II OxZr TKA.
Introduction. Shared decision making (SDM) was introduced in hospital Lillebelt in 2019 and research reports that patients are more satisfied with their treatment, if they play an active role in choosing treatment. A Decision-Helper was constructed and introduced in the treatment for Colles fractures. This study aimed to understand how patients experience shared decision-making (SDM) for an acute illness, and how it affects them when making decisions about the treatment of their distal radius fracture. Method. An exploratory, qualitative
The incisura fibularis (IF) provides intrinsic stability to the ankle joint complex by interlocking the distal tibia and fibula. Despite a high frequency of ligamentous ankle injuries, scant attention has been given to the morphology of the IF morphology incisura fibularis in the onset and development of these lesions. Therefore, we systematically reviewed the relation between ligamentous ankle disorders and the morphometrics of the IF. A systematic literature search was conducted on following databases: PubMed, Embase and Web of Science. Search terms consisted of ‘ankle trauma’, ‘ankle injury’, ‘ankle sprain’, ‘ankle fracture’, ‘tibiofibular’, ‘fibular notch’, ‘fibular incisura’, ‘incisura fibularis’, ‘morphometric analysis’, ‘ankle syndesmosis’, ‘syndesmotic stability’. The evaluation instrument developed by Hawker et al. was used to assess the quality of the selected studies. This protocol was performed according to the PRISMA guidelines and is registered on PROSPERO (CRD42021282862). Nineteen studies were included and consisted of prospective cohort (n=1), retrospective comparative (n=10), and observational (n=8)
Surgical site infections following orthopaedic surgery are a serious complication associated with increased morbidity and mortality. Intra-wound antibiotic powder may be able to provide infection prophylaxis locally with less systemic adverse effects, and promising results have been reported in systematic reviews of its use in spine surgery. This study aims to analyse the efficacy and adverse effect profile of intra-wound antibiotics in reducing surgical site infections in orthopaedic surgery for traumatic pelvic and lower limb fractures. A systematic review was conducted for studies reporting on the incidence of surgical site infections following administration of intra-wound antibiotic powder in pelvic and lower limb trauma surgery. Randomised controlled trials, cohort and case-control studies were included. A meta-analysis was conducted for deep surgical site infections. Seven studies were included in the systematic review including six retrospective case-control studies and one randomised controlled trial. Results of the meta-analysis suggest a potential 23% reduction in the odds of developing a deep surgical site infection in patients treated with intra-operative antibiotic powder compared with those managed with intravenous antibiotics alone (OR 0.77, 95% CI 0.52 – 1.13), although the results did not reach statistical significance. Notable selective bias against intra-wound antibiotics and suboptimal
Atypical femoral fracture non-union (AFFNU) is both, rare (3–5 per 1000 proximal femur fractures) and difficult to treat. Lack of standardised guidelines leads to a variability in fixation constructs, use of bone grafting and restricted weight bearing protocols, which are not evidence based. We hypothesised that there is no change in union rates without the use of bone grafting and immediate weight bearing post-operatively does not lead to increased complications. Materials & Methods. A retrospective review of all consecutively treated AFFNU cases between March 2015 to December 2019 was carried out. 9 patients with a mean age of 63.87 years and M:F ratio of 7:2 met the inclusion criteria. Primary outcome variable was radiographic union at 12 months after revision surgery. All surgeries were carried out by a single surgeon. Fixation construct, neck-shaft angle, use of bone graft and immediate postoperative weight bearing protocols were recorded. Results. Radiographic union was achieved in 7 of 9 patients (78%) after first revision surgery. 1 patient achieved union after 2nd revision surgery and 1 patient died in the early post-operative period due to pulmonary embolism. No bone grafting was used in any of the patients and weight-bearing as tolerated was allowed from the first post-operative day. The mean neck-shaft angle after non-union surgery was 136 degrees. Conclusions. In this case series, the union rate was comparable to those reported in literature previously and achieved without any form of bone grafting. To our knowledge, this is the only case series where no bone grafting was used in the management of AFFNU. Limited by a small sample size and retrospective
Objectives. Cartiva synthetic cartilage implant (SCI) is licenced for use in management of symptomatic hallux rigidus in several countries including the UK. As for now, there are no independent comparative series for treatment of hallux rigidus utilising polyvinyl alcohol implants.
Background. The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture.
A medializing calcaneal osteotomy (MCO) is one of the key inframalleolar osteotomies to correct progressive collapsing foot deformity (PCFD). While many studies were able to determine the hind- and midfoot alignment after PCFD correction, the subtalar joint remained obscured by superposition on plain radiography. Therefore, we aimed to perform a 3D measurement assessment of the hind- and subtalar joint alignment pre- compared to post-operatively using weightbearing CT (WBCT) imaging. Fifteen patients with a mean age of 44,3 years (range 17-65yrs) were retrospectively analyzed in a pre-post