Background. FORECAST is a prospective longitudinal cohort study exploring mechanism-based prognostic factors for pain persistence in sciatica. Here, we share an update on this largest deeply-phenotyped primary care sciatica cohort. Methods/results. Our cohort includes 180 people with sciatica (score >4 on Stynes’ Sum Score), aged 18–85, within 3 months of symptom onset. Psychosocial factors, self-reported sensory profiling, clinical examination, quantitative sensory testing (QST), biological samples (blood and skin samples), and Magnetic Resonance Neurography of lumbar nerve roots were collected at baseline. Pain persistence was determined at three and twelve months with the Sciatica Bothersomeness Index (SBI) and a numeric pain rating scale (NRS) as primary outcomes. Recruitment nears completion, with 160 participants enrolled to date. 127 and 96 participants have completed 3 and 12 months follow-up respectively. Overall, 56% of our cohort are female, with a mean age (SD) of 54.14yrs (16.57). Ethnicity data approximates local populations. SBI at baseline was (median [IQR]) 13[10-17], and interim longitudinal data shows stepwise improvement at 3 and 12 months. Baseline ‘average’ pain intensity was 5.56 (2.15) for leg pain, and 4.14(2.82) for low back pain (LBP). Overall, pain scores decreased at 3 and 12 months, with greater reductions in leg pain than LBP at 12 months. However, around 55–80% and 40–65% of people reported persistent pain at 3 and 12 months respectively. Conclusion. Leg pain severity was moderate and higher than LBP at baseline. All primary outcome measures demonstrate improvement over time, however 40–65% of patients report persistent pain at 12 months. Conflicts of interest. LR: Paid facilitation of post-graduate courses internationally. SK, MT, FP, KM, WS, CP, CR, SC: No conflicts of interest. GC: Editor in Chief of Health Psychology Review. Director of board of directors, MentalCHealth Care setting NoordWestVlaanderen. JF: Copyright holder of ODI (Oswestry Disability Index). Served on a data monitoring committee for a clinical trial of 2 different surgical approaches to cervical disc herniation (FORVAD). Member of
Background. Internet delivered interventions may provide a route to rapid support for behavioural self-management for low back pain (LBP) that could be widely applied within primary care. Although evidence is emerging that more complex technologies (mobile apps linked to digital wristbands) can have some impact on LBP-related disability, there is a need to determine the effectiveness of highly accessible, web-based support for self-management for LBP. Methods and results. We conducted a multi-centre pragmatic randomised controlled trial, testing ‘SupportBack’, an accessible internet intervention developed specifically for primary care. We aimed to determine the effectiveness of the SupportBack interventions in reducing LBP-related physical disability in primary care patients. Participants were randomised to 1 of 3 arms: 1) Usual care + internet intervention + physiotherapy telephone support, 2) Usual care + internet intervention, 3) Usual care alone. Utilising a repeated measures design, the primary outcome for the trial was disability over 12 months using the Roland Morris Disability Questionnaire (RMDQ) at 6 weeks, 3, 6 and 12 months. Results: 826 were randomised, with follow-up rates: 6 weeks = 83%; 3 months = 72%; 6 months = 70%; 12 months = 79%. Analysis is ongoing, comparing each intervention arm versus usual care alone. The key results will be presented at the conference. Conclusion. We believe this to be the largest trial of it's kind internationally. The trial will extend knowledge regarding the effectiveness of highly accessible internet interventions to support self-management and activity in people with LBP consulting in primary care. Conflicts of interest: No conflicts of interest. Source of funding: NIHR
Background. Sciatica is common and associated with significant impacts for the individual, health care and society. The SCOPiC randomised controlled trial (RCT) is investigating whether stratified primary care for sciatica is more effective and cost-effective than usual, non-stratified primary care. Stratified care involves subgrouping patients to one of three groups based on a combination of prognostic and clinical indicators. Patients in one of these groups are ‘fast-tracked’ with an MRI scan to spinal specialist opinion. Our aim was to understand the perspectives of clinicians on the acceptability of this ‘fast-track’ pathway. Methods. Qualitative, semi-structured interviews were conducted with general practitioners, spinal specialist physiotherapists and spinal surgeons (n=20 in total). Interviews were fully transcribed, and data were analysed using the constant comparison method. Results. Across all groups, clinicians identified potential added value in ‘fast-tracking’ some sciatica patients in terms of patient reassurance based on MRI scan findings. Whilst spinal physiotherapists felt that most ‘fast track’ patients were appropriate, some spinal physiotherapists and GPs had concerns that patients with symptom durations of less than 6 weeks might be inappropriately fast-tracked since their symptoms may still resolve without the need for invasive treatments. Spinal surgeons felt it was acceptable for patients with short symptom durations to be ‘fast-tracked’, but to provide early reassurance rather than direct treatment. Conclusion. Whilst clinicians saw added value in a group of sciatica patients being ‘fast-tracked’ to specialist opinion, there was some reservation about moving away from the usual stepped care, ‘wait and see’ approach for patients with short symptom duration. Conflicts of interest statement. No conflicts of interest. Sources of funding. This study is funded by the National Institute for Health Research Health Technology Assessment Programme (NIHR
Background and purpose. The prevalence of back pain has remained relatively constant in the population in spite of previous interventions. Persons with sub-acute back pain are assumed to benefit from extended multidisciplinary, interdisciplinary or transdiciplinary and multisectorial, intersectorial or trans-sectorial interventions as an alternative to traditional mono-professional interventions. The purpose of this health technology assessment (HTA) was to document the possible effect of such interventions in patients suffering from back pain of 4-12 weeks duration. Methods and results. A systematic literature review is the overall basis for this
For decades, universities and research centers have been applying modeling and simulation (M&S) to problems involving health and medicine, coining the expression in silico clinical trials. However, its use is still limited to a restricted pool of specialists. It is here proposed an easy-to-use cloud-based platform that aims to create a collaborative marketplace for M&S in orthopedics, where developers and model creators are able to capitalize on their work while protecting their intellectual property (IP), and researcher, surgeons and medical device companies can use M&S to accelerate time and to reduce costs of their research and development (R&D) processes. Digital libraries on . InSilicoTrials.com. are built on collaborations among first-rate research center, model developers, software, and cloud providers (partners). Their access is provided to life science and healthcare companies, clinical centers, and research institutes (users), offering them with several solutions for the different steps of the orthopedics and medical devices R&D process. The platform is built using the Microsoft Azure cloud services, conforming to global standards of security and privacy for healthcare, ensuring that clinical data is properly managed, protected, and kept private. The environment protects the IP of partners against the downloading, copying, and changing of their M&S solutions; while providing a safe environment for users to seamlessly upload their own data, set up and run simulations, analyze results, and produce reports in conformity with regulatory requirements. The proposed platform allows exploitation of M&S through a Software-as-a-Service delivery model. The pay-per-use pricing: 1. provide partners with a strong incentive to commercialize their high-quality M&S solutions; 2. enable users with limited budget, such as small companies, research centers and hospitals, to use advanced M&S solutions. Pricing of the M&S tools is based on specific aspects, such as particular features and computational power required, in agreement with the developing partner, and is distinct for different types of customers (i.e., academia or industry). The first medical devices application hosted on . InSilicoTrials.com. is NuMRis (Numerical Magnetic Resonance Implant Safety), implemented in collaboration with the U.S. F.D.A. Center for Devices and Radiological Health, and ANSYS, Inc. The automatic tool allows the investigation of radiofrequency (RF)-induced heating of passive medical implants, such as orthopedic devices (e.g., rods and screws), pain management devices (e.g., leads), and cardiovascular devices (e.g., stents), following the ASTM F2182-19e2 Standard Test Method. NuMRis promotes the broader adoption of digital evidence in preclinical trials for RF safety analysis, supporting the device submission process and pre-market regulatory evaluation. InSilicoTrials.com. aims at defining a new collaborative framework in healthcare, engaging research centers to safely commercialize their IP, i.e., model templates, simulation tools and virtual patients, by helping clinicians and healthcare companies to significantly expedite the pre-clinical and clinical development phases, and to move across the regulatory approval and
Aim: To assess the volume-outcome relationship of total hip replacement means of a Health Technology Assessment and to assess the effects of a minimum provider volume regulation on medical care in Germany. Methods: Electronic bibliographic databases, the reference lists of relevant articles and various health services research-related resources were searched and selected studies were assessed using defined quality criteria. Additionally, the implementation of these results and its consequences – excluding hospitals and/or surgeons that do not perform a defined number of operations a year from medical care – for the German Health System were calculated on routine data basis of the German Health insurance. Several different cut-off points (20 operations per year/50 operations per year) and the respective consequences on medical care were calculated. Results: 26 publications, that comprise in a narrower sense with the volume-outcome-relationship of total hip replacement, were assessed. The results in literature concerning defined outcome parameters are inconsistent, but a general correlation between high volume and low complication rate could be identified. In contrast a cut-off point, that is able to discriminate “good” from “bad” health care could not be deduced from the results in the literature. Methodological aspects of the performed studies concerning volume-outcome relationship are to be considered, too, i.e. study design, statistics, endpoint definition. In Germany 1264 hospitals performed 150.000 total hip replacements in 2005. Implementing a regulation based on minimum provider volumes of 20/50 total hip replacements/year would lead to an exclusion of 216 (17%)/483 (38%)hospitals respectively from medical care. This would result in a reallocation of 2214 (1.4%)/11.478 (7,4%) patients/ year respectively. Conclusion: Importance of
Funding. This report presents independent research commissioned by the National Institute for Health Research (NIHR) (NIHR
Background and Purpose. Healthcare for sciatica is usually ‘stepped’ with initial advice and analgesia, then physiotherapy, then more invasive interventions if symptoms continue. The SCOPiC trial tested a stratified care algorithm combining prognostic and clinical characteristics to allocate patients into one of three groups, with matched care pathways, and compared the effectiveness of stratified care (SC) with non-stratified, usual care (UC). Methods. Pragmatic two-parallel arm RCT with 476 adults recruited from 42 GP practices and randomised (1:1) to either SC or UC (238 per arm). In SC, participants in group 1 were offered up to 2 advice/treatment sessions with a physiotherapist, group 2 were offered up to 6 physiotherapy sessions, and group 3 was ‘fast-tracked’ to MRI and spinal specialist opinion. Primary outcome was time to first resolution of sciatica symptoms (6-point ordinal scale) collected via text messages. Secondary outcomes (4 and 12 months) included leg and back pain intensity, physical function, psychological status, time-off-work, satisfaction with care. Primary analysis was by intention to treat. Results. Primary outcome data were obtained from 89.3% (88.3% SC, 90.3% UC). Survival analysis showed a small but not statistically significant difference in time to resolution of symptoms (SC reached resolution 2 weeks earlier than UC; HR 1.14 (95% CI 0.89, 1.46)). There were no significant between-arm differences in secondary outcomes. Conclusion. The SC model, tested in this trial was not more effective than UC. On average, patients in both arms made similar good improvements over time, on most outcomes. No conflicts of interest. Funding: This report presents independent research commissioned by the National Institute for Health Research (NIHR) (NIHR
In 2017, the British Society for Children’s Orthopaedic Surgery engaged the profession and all relevant stakeholders in two formal research prioritization processes. In this editorial, we describe the impact of this prioritization on funding, and how research in children’s orthopaedics, which was until very recently a largely unfunded and under-investigated area, is now flourishing. Establishing research priorities was a crucial step in this process. Cite this article:
Background. Recruitment to time and target in clinical trials is a key challenge requiring careful estimation of numbers of potential participants. The SCOPiC trial ((HTA 12/201/09) (ISRCTN75449581)) is investigating the clinical and cost-effectiveness of stratified care for patients with sciatica in primary care. Here, we describe the approaches followed to achieve recruitment of our required sample size (n=470), the challenges encountered and required adaptations. Methods. We used recruitment data from the SCOPiC trial and its internal pilot, to show the differences between estimated and actual numbers of patients from consultation to participation in the trial. Patients were consented to the trial if they had a clinical diagnosis of sciatica (with at least 70% confidence) and met the trial eligibility criteria. Results. Initial recruitment estimates suggested we needed a source population of 146,000 adults registered at approximately 30 GP practices, and a monthly trial recruitment target of 22 patients per month over 22 months. The internal pilot trial phase resulted in revisions of these estimates to 256,000 and 42 GP practices. To date, 1,623 patients have been screened for eligibility and 450 randomised. The main reason for ineligibility is low confidence in the diagnosis of sciatica. Conclusion. Our experience highlights the challenge of recruitment to clinical trials of sciatica, particularly in terms of case definition, and the need for careful planning and an internal pilot phase prior to a main trial. We believe our experience will be helpful to others conducting trials with sciatica patients. No conflicts of interest. Funding. NEF is an NIHR Senior Investigator. KK is supported through a HEFCE Senior Clinical Lecturer award. The SCOPiC trial is funded by the National Institute for Health Research Health Technology Assessment Programme (NIHR
Purpose and background. Over two-thirds of pregnant women experience low back pain (LBP) that interferes with everyday activities, work and sleep. Acupuncture appears a safe, promising intervention but there are no high quality trial data, regarding its clinical or cost-effectiveness in comparison to standard care. Methods. EASE Back was a feasibility and pilot RCT designed to inform a full trial evaluating the addition of acupuncture to standard care for pregnancy-related LBP. In preparation for the pilot trial, phase 1 of EASE Back consisted of semi-structured interviews exploring the views of pregnant women, midwives and physiotherapists about pregnancy-related LBP, use of acupuncture, and participation in clinical trials. Transcript data were anonymised and analysed using thematic analysis. Three members of the team independently coded a sample of transcripts to develop the coding framework. Results. 17 women, 15 midwives and 21 physiotherapists were interviewed (total n=53). Findings highlighted the impact of LBP in pregnancy, the paucity of effective treatment options and the challenges of recruiting pregnant women with LBP into research. Women and midwives expressed few concerns over the use and safety of acupuncture; physiotherapists were more cautious and had concerns about safety. Conclusions. Acupuncture for pregnancy- related LBP appears to be acceptable to women and midwives. Future research needs to consider strategies to support recruitment and retention, and should consider including interviews with eligible women who decline to take part in order to understand their reasons, as well as with women receiving treatment so as to understand their experiences of taking part. This abstract has not been published in whole or substantial part, nor has it been presented previously at a national meeting. Conflicts of interest: No conflicts of interest. This project presents independent research funded by the National Institute for Health Research's Health Technology Assessment Programme (Grant Reference Number 10/69/05) and an NIHR Research Professorship for N.E. Foster (NIHR-RP-011-015). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the
Purpose: SWISSspine is a national health technology assessment (HTA) registry for ballon kyphoplasty (BKP) and total disc arthroplasty (TDA). It was initiated to evaluate the safety, efficiency and cost-effectiveness of these products. It is the first mandatory orthopaedic
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. SOFFT is a multicentre, pragmatic, two-arm parallel-group, non-inferiority, randomized controlled trial. Participants will be assigned 1:1 to receive either tension suture fixation or tension band wiring. 280 adult participants will be recruited. The primary outcome will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at four months post-randomization. Secondary outcome measures include DASH (at 12, 18, and 24 months), pain, Net Promotor Score (patient satisfaction), EuroQol five-dimension five-level score (EQ-5D-5L), radiological union, complications, elbow range of motion, and re-operations related to the injury or to remove metalwork. An economic evaluation will assess the cost-effectiveness of treatments.Aims
Methods
Patterns of extra-spinal skeletal length asymmetry have been reported for upper limbs [1] and ribcage [2] of patients with upper spine adolescent idiopathic scoliosis. This paper reports a third pattern in the ilia. Seventy of 108 consecutive adolescent patients referred from routine scoliosis school screening during 1996–1999 had lower spine scoliosis – lumbar (LS), thoracolumbar (TLS), or pelvic tilt scoliosis (PTS). Radiologic bi-iliac and hip tilt angles were both measurable in 60 subjects: LS 18, TLS 31, and PTS 11 (girls 44, boys 16, mean age 14.6 years). Cobb angle (CA), apical vertebral rotation (AVR) and apical vertebral translation from the T1-S1 line (AVT) were measured on standing full spine radiographs (mean Cobb angle 14 degrees, range 4–38 degrees, 33 left, 27 right curves). Bi-iliac tilt angle (BITA) and hip tilt angle (HTA) were measured trigonometrically and iliac height asymmetry calculated as BITA minus
Introduction: We investigated the use of suture repair for tuberosities in hemiarthroplasty for 4 part fractures, by examining cadaveric repairs after repetitive loading tests. Sutures are the most popular repair tool currently. However tuberosity “disappearance” with this is common; and touted as the prime cause for failure. In some studies biochemical lysis has been suggested to explain this. The aim of this study was to analyse the mode of failure. Materials and Methods: Tests were carried out in line with UK
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). 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 study design and will assist with aspects of trial delivery and dissemination.Aims
Methods
Introduction: The upper edge of pectoralis major tendon insertion (PMTI) on the humerus is touted as a reference to restore humeral height, to be used in hemi-arthroplasty for proximal humeral fracture. The aim of the study was to verify the reliability of reference and ease of its use in routine practice. Materials and Methods: Tests were carried out in line with UK
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. This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation.Aims
Methods
Ankle fracture is one of the most common musculoskeletal injuries sustained in the UK. Many patients experience pain and physical impairment, with the consequences of the fracture and its management lasting for several months or even years. The broad aim of ankle fracture treatment is to maintain the alignment of the joint while the fracture heals, and to reduce the risks of problems, such as stiffness. More severe injuries to the ankle are routinely treated surgically. However, even with advances in surgery, there remains a risk of complications; for patients experiencing these, the associated loss of function and quality of life (Qol) is considerable. Non-surgical treatment is an alternative to surgery and involves applying a cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint with the key benefit being a reduction in the frequency of common complications of surgery. The main potential risk of non-surgical treatment is a loss of alignment with a consequent reduction in ankle function. This study aims to determine whether ankle function, four months after treatment, in patients with unstable ankle fractures treated with close contact casting is not worse than in those treated with surgical intervention, which is the current standard of care. This trial is a pragmatic, multicentre, randomized non-inferiority clinical trial with an embedded pilot, and with 12 months clinical follow-up and parallel economic analysis. A surveillance study using routinely collected data will be performed annually to five years post-treatment. Adult patients, aged 60 years and younger, with unstable ankle fractures will be identified in daily trauma meetings and fracture clinics and approached for recruitment prior to their treatment. Treatments will be performed in trauma units across the UK by a wide range of surgeons. Details of the surgical treatment, including how the operation is done, implant choice, and the recovery programme afterwards, will be at the discretion of the treating surgeon. The non-surgical treatment will be close-contact casting performed under anaesthetic, a technique which has gained in popularity since the publication of the Ankle Injury Management (AIM) trial. In all, 890 participants (445 per group) will be randomly allocated to surgical or non-surgical treatment. Data regarding ankle function, QoL, complications, and healthcare-related costs will be collected at eight weeks, four and 12 months, and then annually for five years following treatment. The primary outcome measure is patient-reported ankle function at four months from treatment.Aims
Methods