Aims. To explore staff experiences of a multicentre pilot randomized controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures. Methods. A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants’ experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone, and were analyzed using thematic analysis. Results. The findings identify that for the treatment of segmental tibial fractures
Objectives. The number of surgical procedures performed each year to treat
femoroacetabular impingement (FAI) continues to rise. Although there
is evidence that surgery can improve symptoms in the short-term,
there is no evidence that it slows the development of osteoarthritis
(OA). We performed a feasibility study to determine whether patient
and surgeon opinion was permissive for a Randomised Controlled Trial
(RCT) comparing operative with non-operative treatment for FAI. Methods. Surgeon opinion was obtained using validated questionnaires at
a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely
performed FAI surgery) and patient opinion was obtained from clinical
patients with a new diagnosis of FAI (n = 31). Results. Clinical
After 25 years in orthopaedic oncology the author wishes to set a challenge for the next generation by posing 10 questions which he believes still do not have answers and which may improve outcomes for patients with sarcomas Why are sarcomas diagnosed so late? Can we ever decide what is a safe margin? What is the role of neoadjuvant chemotherapy for STS? What can we do to decrease the risk of infection after limb salvage surgery? What is the significance of local recurrence on outcome? What really is the best treatment for Ewing's sarcoma of the pelvis? Is cross sectional imaging essential as part of patient follow up? Is it possible to evaluate outcomes combining survival and function? Why can't we run a surgical trial in orthopaedic oncology? How can we evaluate surgical success? The author suggests ways these questions may be answered.
Aims. A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. Methods. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on
Aim. Pelvic osteomyelitis following pressure ulceration results in substantial patient morbidity. Previous studies have reported a heterogenous approach to diagnosis and medical management by physicians, suggesting
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
Aims. People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding
Displaced fractures of the distal radius in children are usually reduced under sedation or general anaesthesia to restore anatomical alignment before the limb is immobilized. However, there is growing evidence of the ability of the distal radius to remodel rapidly, raising doubts over the benefit to these children of restoring alignment. There is now clinical
Salter-Harris II fractures of the distal tibia affect children frequently, and when they are displaced present a treatment dilemma. Treatment primarily aims to restore alignment and prevent premature physeal closure, as this can lead to angular deformity, limb length difference, or both. Current literature is of poor methodological quality and is contradictory as to whether conservative or surgical management is superior in avoiding complications and adverse outcomes. A state of clinical
Aims. The aim of this study was to evaluate the epidemiology and treatment of Perthes’ disease of the hip. Methods. This was an anonymized comprehensive cohort study of Perthes’ disease, with a nested consented cohort. A total of 143 of 144 hospitals treating children’s hip disease in the UK participated over an 18-month period. Cases were cross-checked using a secondary independent reporting network of trainee surgeons to minimize those missing. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants. Results. Overall, 371 children (396 hips) were newly affected by Perthes’ disease arising from 63 hospitals, with a median of two patients (interquartile range 1.0 to 5.5) per hospital. The annual incidence was 2.48 patients (95% confidence interval (CI) 2.20 to 2.76) per 100,000 zero- to 14-year-olds. Of these, 117 hips (36.4%) were treated surgically. There was considerable variation in the treatment strategy, and an optimized decision tree identified joint stiffness and age above eight years as the key determinants for containment surgery. A total of 348 hips (88.5%) had outcomes to two years, of which 227 were in the late reossification stage for which a hip shape outcome (Stulberg grade) was assigned. The independent predictors of a poorer radiological outcome were female sex (odds ratio (OR) 2.27 (95% CI 1.19 to 4.35)), age above six years (OR 2.62 (95% CI (1.30 to 5.28)), and over 50% radiological collapse at inclusion (OR 2.19 (95% CI 0.99 to 4.83)). Surgery had no effect on radiological outcomes (OR 1.03 (95% CI 0.55 to 1.96)). PROMs indicated the marked effect of the disease on the child, which persisted at two years. Conclusion. Despite the frequency of containment surgery, we found no evidence of improved outcomes. There appears to be a sufficient case volume and community
Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021). Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings. The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of
Randomised controlled clinical trials (RCTs) produce the most reliable evidence about the effects of clinical care. In surgical trials, lack of surgeons’ individual
Displaced acetabular fractures in the older patient present significant treatment challenges. There is evidence the morbidity and mortality associated is similar to the fractured neck of femur cohort. Despite growing literature, there remains significant controversy regarding treatment algorithms; varying between conservative management, to fracture fixation and finally surgical fixation and simultaneous THA to allow immediate full weight bearing. £250k NIHR, Research for Patient Benefit (Ref: PB-PG-0815-20054). Trial ethical approval (17/EE/0271). After national consultation, 3 arms included; conservative management, fracture fixation and simultaneous fracture fixation with THA. Statistical analysis required minimum 12 patients/3 arms to show feasibility, with an optimum 20/arm. Inclusion criteria; patients >60 years & displaced acetabular fracture. Exclusion criteria: open fracture, THA in situ, pre-injury immobility, polytrauma. Primary outcome measure - ability recruit & EQ-5D-5L at 6 months. Secondary outcome measures (9 months); OHS, Disability Rating Index, radiographs, perioperative physiological variables including surgery duration, blood loss, complications and health economics. 11 UK level 1 major trauma centres enrolled into the trial, commenced December 2017. Failure surgical
Considerable debate exists regarding which agent(s) should be preferred for venous thromboembolism (VTE) chemical prophylaxis following joint replacement. We assessed the practice of surgeons regarding VTE chemical prophylaxis for primary THR and TKR, pre and post issuing of updated NICE guidance in 2018. A survey, circulated through the British Hip Society and regional trainee networks/collaboratives, was completed by 306 UK surgeons at 187 units. VTE chemical prophylaxis prescribing patterns for surgeons carrying out primary THR (n=258) and TKR (n=253) in low-risk patients were assessed post publication of 2018 NICE recommendations. Prescribing patterns before and after the NICE publication were subsequently explored. Questions were also asked about surgeon
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
Introduction and Aims: Randomised controlled trials (RCTs) are frequently presented as the best design for studies of treatment effect because they minimise bias from unknown confounders. But, very few have been performed in orthopaedic and trauma surgery in comparison to other areas of medicine. This study investigated the perceived obstacles to performing RCTs, in order to identify areas where novel aspects of study design may facilitate randomisation in orthopaedic research. Method: A qualitative study was performed using a deliberate maximum variation sample of 24 orthopaedic surgeons from four countries, involved in all aspects of practice, teaching, research, research funding, ethical approval and publication. A semi-structured interview was used to explore surgeons’ perceptions of obstacles to performing RCTs. A computer-assisted framework approach was used to analyse transcripts of these interviews, and to identify consistent themes and connections between them. Results: Thirty-four discrete obstacles to performing RCTs in trauma and orthopaedic surgery were identified and classified. Many of these fell into six main themes:. A non-evaluative culture;. Misunderstanding of the scientific basis of trial design;. Lack of individual
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Background. Clavicle development occurs before the age of 9 in females and 12 in males. Children below the age of 10 with displaced midshaft clavicle fractures recover well with conservative management. However adolescents are more demanding of function and satisfaction following clavicle fractures and may benefit from operative management. Study aims: 1) Perform a systematic review of the current evidence supporting intramedullary fixation of adolescent clavicle fractures. 2) Review current management in a major trauma center (MTC) with a view to assess feasibility for a randomised controlled trial (RCT). Methods. The MEDLINE, EMBASE and AMED databases were searched in October 2014 to identify all English language studies evaluating intramedullary fixation in children aged 10–18 years using MeSH terms. Data was extracted using a standardised data collection sheet and studies were critically appraised by aid of the PRISMA checklist. All patients aged 9–15 attending an MTC receiving clavicle radiographs in 2014 were retrospectively reviewed for type of fracture, management and outcome. Results. Literature search identified 54 articles. After application of exclusion criteria 3 studies were selected for final review. 47 adolescent patients received intramedullary clavicle fixation from a prospective and two retrospective case series. 61 adolescents presented to our unit with a clavicle fracture in 2014, 2 were lost to follow-up, 54 were managed non-operatively, 3 received titanium-elastic nailing, 1 plate osteosynthesis and 1 bone suture. 0 and 19 patients reported a palpable lump, mean time to pain resolution was 4 and 6 weeks and time to full range of motion was 4 and 5 weeks following operative and conservative management respectively. All patients reached radiographic union. Conclusion. Current evidence supporting intramedullary fixation of clavicle fractures in adolescents is poor. There remains clinical