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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 16 - 16
7 Aug 2024
Ridgway L Koushesh S Tachrount M Probert F Martin K Scott W Crombez G Price C Robinson C Clare S Fairbank J Baskozos G Schmid A
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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 HTA Prioritisation Committee B: Inside hospital Care from 2015-February 2019. Member of HTA Interventional Procedures Panel from 2010–2015. Trustee and board member of 3 spine related charities – Back to Back; British Scoliosis Research Foundation and BackCare. Expert instructed by both claimant and defendant solicitors in negligence and person injury cases. GB: Paid consultancy (RNA-seq) with Ivy Farm and Coding.bio. ABS: Paid post-graduate lecturing internationally. Co-chair NeupSig sciatica working group (unpaid). Sources of funding. This project is funded by UKRI and Versus Arthritis as part of the UKRI Strategic Priorities Fund (SPF) Advanced Pain Discovery Platform (APDP), a co-funded initiative by UKRI (MRC, BBSRC, ESRC), Versus Arthritis, the Medical Research Foundation and Eli Lilly and Company Ltd (Grant MR/W027003/1). Additional funding has been received from the back to back charity to expand longitudinal components of the study. LR has received support with PhD fees from the CSP charitable trust. ABS is supported by a Wellcome Trust Clinical Career Development Fellowship. (222101/Z/20/Z). WS is partly funded through the National Institute for Health and Care Research (NIHR) Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and King's College London. FP is funded by a Dorothy Hodgkin Career Development Fellowship in Chemistry in association with Somerville College. GB is supported by the Wellcome Trust (223149/Z/21/Z) and Diabetes UK (19/0005984). GC and KRM are partly funded by UKRI and Versus Arthritis as part of the Advanced Pain Discovery Platform (APDP) PAINSTORM (MR/W002388/1). The UKRI and Versus Arhthritis (APDP) are the major funders of FORECAST. All other funders provided either some people support, or funded projects with legacy data that we reuse


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 25 - 25
1 Oct 2022
Geraghty A Roberts L Hill J Foster N Stuart B Yardley L Hay E Turner D Griffiths G Webley F Durcan L Morgan A Hughes S Bathers S Butler-Walley S Wathall S Mansell G Leigh L Little P
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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 HTA Project number 16/111/78


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_9 | Pages 21 - 21
1 Sep 2019
Saunders B Bartlam B Artus M Foster N Konstantinou K
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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 HTA project number 12/201/09) and will be published in full in Health Technology Assessment. Funding support is also received from an NIHR Research Professorship for Nadine Foster (NIHR-RP-011-015), who is an NIHR Senior Investigator, and a HEFCE Senior Clinical Lecturer award for Kika Konstantinou. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health and Social Care. The study was approved by the NRES Committee West Midlands – Solihull, 17/03/2015, ref: 15/WM/0078. Trial registration: ISRCTN75449581


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 20 - 20
1 Jan 2012
Hartvigsen J Lovschall C Bech M Rasmussen C Petersen T Jensen C Douw K
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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 HTA and the analysis of the interventions in relation to technology, patients, organization, and economics. HTA reports, systematic reviews, and recent primary studies were included. Further, primary data from Danish institutions (public and private) with experience in working with this technology were collected. There is moderate evidence that early multidiciplnary, interdisciplinary and transdiciplinary interventions are more effective than monodiciplinary interventions or no interventions in primary care. The effects are mainly seen in relation to reduced sick leave at or beyond 12-months follow-up and not in relation to reduced pain or improved function. The interventions appear to be cost-effective. Danish back centers mainly use sequential and/or parallel collaborative models. Conclusions. Extended multidisciplinary, interdisciplinary or transdiciplinary and multisectorial, intersectorial or trans-sectorial interventions delivered to patients with back pain of 4-12 weeks duration reduce sick-leave and appear to be cost-effective. The optimal content of such interventions cannot be determined but elements of cognitive behavioral therapy combined with graded exercise is used most frequently


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_4 | Pages 53 - 53
1 Mar 2021
Carbone V Baretta A Lucano E Palazzin A Bisotti M Bursi R Emili L
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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 HTA processes


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 HTA reports and expected consequences on health care will even increase in Germany especially regarding recent legal context. A correlation between high volume and low complication rate in total hip replacement could be identified by means of HTA. Keeping these results in mind and knowing that in consequence hospitals/surgeons that do not perform a defined number of operations a year will be excluded from medical care, the application of a minimum provider volume regulation in the German health care system must be performed very sensitve, because significant effects are to be expected


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 27 - 27
1 Oct 2019
Kigozi J Lewis M Konstantinou K Foster N Jowett S
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Funding. This report presents independent research commissioned by the National Institute for Health Research (NIHR) (NIHR HTA project number 12/201/09). NEF is a Senior NIHR Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). KK was supported by a HEFCE Senior Clinical Lectureship award. 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 Health Technology Assessment programme or the Department of Health. Background and Purpose. Stratified care (SC) has previously been found to be a cost-effective approach for primary care LBP patients. The SCOPiC trial compared the clinical and cost-effectiveness of a modified SC model combining prognostic and clinical characteristics to allocate sciatica patients into one of three groups (with matched care pathways) versus non-stratified, usual care (UC). Methods. Cost-utility analysis was undertaken over 12-months. Resource use and quality of life (EQ-5D-5L) data were obtained from postal questionnaires, mean costs and QALYs were calculated for each trial arm along with cost-effectiveness acceptability curves. The base case analysis was by intention-to-treat, and performed from NHS and personal social services (PSS) perspective. Sensitivity analyses included healthcare provider and societal perspectives, as well as analyses for each of the three patient groups. Results. 476 patients were randomised (238 per arm). Mean NHS/PSS costs (SD) recorded were £663.58 for SC and £617.37 for UC. Mean QALYs (SD) were 0.659 (0.173) for SC and 0.671 (0.168) for UC; the adjusted mean difference in QALYs was −0.011 (−0.035, 0.013). In this base-case analysis, the chance of SC being cost-effective at a threshold of £30,000 per QALY was only 19%. Similarly, low probabilities of effectiveness were observed in all sensitivity analyses. The chance of SC being cost-effective at a threshold of £30,000 ranged from 18% to 52% for each of the three patient groups. Conclusions. Overall, the SC model that we tested for sciatica in primary care was not a cost-effective option compared to usual, non-stratified care. No sources of funding. No conflicts of interest


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_10 | Pages 2 - 2
1 Oct 2019
Konstantinou K Lewis M Dunn K Hill J Artus M Foster N
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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 HTA project number 12/201/09). NEF is a Senior NIHR Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). KK was supported by a HEFCE Senior Clinical Lectureship award. 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 Health Technology Assessment programme or the Department of Health


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 422 - 424
1 May 2024
Theologis T Perry DC

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: Bone Joint J 2024;106-B(5):422–424.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 25 - 25
1 Feb 2018
Konstantinou K Rimmer Y Huckfield L Stynes S Burgess N Foster N
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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 HTA project number 12/201/09). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_2 | Pages 12 - 12
1 Feb 2015
Bartlam B Waterfield J Lloyd A Holden M Ismail K Foster N
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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 HTA or the Department of Health


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.

Methods

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.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 563 - 563
1 Oct 2010
Diel P Aebi M Aghayev E Moulin P Reuss W Röder C
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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 HTA registry of its kind in Switzerland. The aim is to generate evidence for a decision about reimbursement by the Swiss basic health insurance. Methods: During the time between March 2005 until June 2008, 331 interventions with 391 treated levels in 320 patients have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry is three years. Data collection is performed preoperative, at 6 weeks, 3 months, 6 months and 1 year followup as well as annually thereafter. Surgery and followup case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by patients. Results: Significant and clinically relevant reduction of back pain, improvement of quality of life and reduction of pain killer consumption was seen in the 1 year followup. Improvement of preoperative segmental kyhposis was achieved in the majority of cases. There were three symptomatic cement extrusions with radiculopathy documented. Conclusion: BKP is a safe and effective treatment concerning pain reduction, quality of life improvement and pain killer consumption. The SWISSspine registry proved to be an excellent tool for evaluation of this new technology and its results lead to a permanent coverage of BKP by the basic health insurance


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_III | Pages 445 - 445
1 Aug 2008
Burwell R Aujla R Freeman B Cole A Kirby A Pratt R Webb J Moulton A
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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 HTA (corrected BITA=CBITA) and directly as iliac height asymmetry. Iliac height is relatively taller on the concavity of these curves (p< 0.001). CBITA is associated with Cobb angle, AVR and AVT (each p< 0.001). Conclusion: The relatively taller concave ilium may be 1) real from primary skeletal changes or asymmetric muscle traction on iliac apophyses [3], or 2) apparent from rotation/torsion at the sacro-iliac joint(s)


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 162 - 162
1 May 2011
Borowsky K Raghuprasad V Wear L Stevenson T Marsden N Trent N Bennett A
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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 HTA regulations. Eight fresh frozen cadaver shoulders were stripped of all soft tissue except the rotator cuff. A 4 part fracture was then created by osteotomising the tuberosities. A standard hemiarthroplasty implant was cemented in at the native height and retroversion. A tuberosity repair with Ethibond 5 sutures, employed transverse cerclage sutures; and vertical figure of eight repairs, from the cuff to a shaft drill hole. The repairs were subjected to cyclical tension on the cuff musculature, and simultaneous gleno-humeral motion; using a test process we have described separately. During the entire process the repair site was videoed. At the end of 8000 cycles the tuberosities were probed with a forceps, to record any movement in vertical, horizontal and axial planes. The humeral shaft was also rotated to check for dissociation between tuberosities and shaft. Results: Uniform failure of the hold on the tuberosities occurred by 8000 cycles. Defining failure as movement of any tuberosity more than 3mm, failure rate was 100% (exact 95% confidence interval 65.2 – 100% due to sample size). Movements of at least 1cm were commonly observed. The sutures were loose but never snapped. Failure mechanisms involved digging of the sutures into the tendon, cutting of the sutures through bone, loss of cancellous supporting structure, and migration of the sutures. Failure occurred early in what we considered to the parallel of 1 to 2 weeks of rehabilitation. Conclusion: Suture repair of tuberosities has a high chance of failure if the cuff can not be prevented from contracting. We believe failure is early and mechanical, rather than by lysis or biochemical means. More effective alternatives to suture techniques would be desirable


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

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 study design and will assist with aspects of trial delivery and dissemination.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 201 - 202
1 May 2011
Prasad VR Borowsky K Stevenson T Wear L Marseden N Trent N Bennett A
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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 HTA regulations. 21 fresh frozen shoulders were stripped of all tissues except the rotator cuff and the PMTI. In each specimen the tuberosities were osteotomised, and the humeral head dislocated. The top margin of the PMTI was sought and marked. A flat object was held on the top of the humeral head perpendicular to the shaft and the vertical height from upper edge of PMTI to this object was measured. Results: The 21 measurements (12 right +9 left) had a mean height of 5.98cm (95% CI: 5.64 – 6.31cm). The range of heights was 5 to 7.3 cm for all shoulders and also for right and left sides separately. Eighteen of these 21 shoulders were a pair i.e. right and left of 9 cadavers. The average height for 12 right shoulders was 5.91cm and for the left side average height was 6.05cm. The heights for a pair matched within 0.5 cm only in four pairs (8 shoulders) and exactly in only two pairs (4 shoulders) of specimens. The maximum difference in heights for one pair of shoulders from the same cadaver was as large as 1.4 cm. In comparison to previous studies our measurements were significantly greater than 5.6 cm (P = 0.029). Furthermore, there were 4 measurements of at least 7cm (19.0%, 95%CI: 5.4 – 41.9%). Conclusion: Proximal humeral fracture treatment is a clinical challenge. In these fractures, usually all the ‘bony’ landmarks are lost. In these circumstances an anatomical landmark is needed to navigate from, and the upper edge of PMTI serves as a reference in restoring the height. We found the average values for height to be larger than previously reported. Additionally the notion that the contra-lateral side can be used to calculate the height as a percentage of the length, accepting an error of +/− 0.5cm; was not corroborated. In 3 cases of the 9 pairs available a difference of 14, 7 and 6mm was seen. Lastly in certain cases a flimsy layer of fascia curved superiorly at the top margin, and we were in doubt as to whether to take this fascial extension as the top margin; in one case this flimsy layer also had muscular tissue attached. Though use of the fixed value had on our testing, a wider range than reported, we feel that PMTI is a useful landmark in these operations


Bone & Joint Open
Vol. 5, Issue 6 | Pages 499 - 513
20 Jun 2024
Keene DJ Achten J Forde C Png ME Grant R Draper K Appelbe D Tutton E Peckham N Dutton SJ Lamb SE Costa ML

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.

Methods

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.


Bone & Joint Open
Vol. 5, Issue 3 | Pages 184 - 201
7 Mar 2024
Achten J Marques EMR Pinedo-Villanueva R Whitehouse MR Eardley WGP Costa ML Kearney RS Keene DJ Griffin XL

Aims

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.

Methods

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.


The Bone & Joint Journal
Vol. 103-B, Issue 8 | Pages 1328 - 1330
1 Aug 2021
Gwilym SE Perry DC Costa ML