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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 79 - 79
11 Apr 2023
Underwood T Mastan S O'Brien S Welton C Woodruff M
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There has been extensive research into neck of femur fractures in the elderly. Fragility non-hip femoral fractures share many of the same challenges [1]. Surgical management is complex, patients are frail and mortality rates have been reported as high as 38% [2]. Despite this, relatively little data is available evaluating the level of MDT care provided to non-hip femoral fractures. This audit aimed to evaluate the standard of MDT care provided for patients with non-hip femoral fractures according to the NHFD key performance indicators. The following fractures were included in the dataset: distal femoral, femoral shaft and peri-prosthetic femoral. Patients under 65 were excluded. Data was retrospectively collected using post-operative and medical documentation. Performance was assessed according to five key performance indicators:. Did orthogeriatrics review the patient within 72-hours?. Was surgery performed within 36-hours?. Was the patient weight bearing post-operatively?. Was a confusion assessment completed?. Was the patient discharged home?. 38 patients met the inclusion criteria. 84% of patients were seen by orthogeriatrics within 72 hours of admission. 32% of patients were operated on within 36-hours of admission, with time to theatre exceeding 36-hours in 92% of peri-prosthetic fractures. 37% of patients were not advised to full weight bear post operatively. 84% of patients received a confusion assessment whilst 61% of patients were discharged to their prior place of living. Our results suggest that non-hip femoral fractures do not receive the same standard of MDT care as neck of femur fractures. Greater prioritisation of resources should be given to this patient subset so that care is equivalent to hip-fracture patients. Time to surgery is a particular area for improvement, particularly in peri-prosthetic fractures, a trend that is mirrored nationally. Greater emphasis should be placed on encouraging full-weight bearing post-operatively to prevent post-surgical complications


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 23 - 23
4 Apr 2023
Stoffel K Zderic I Pastor T Woodburn W Castle R Penman J Saura-Sanchez E Gueorguiev B Sommer C
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Treatment of simple and complex patella fractures represents a challenging clinical problem. Controversy exists regarding the most appropriate fixation method. Tension band wiring, aiming to convert the pulling forces on the anterior aspect of the patella into compression forces across the fracture site, is the standard of care, however, it is associated with high complication rates. Recently, anterior variable-angle locking plates have been developed for treatment of simple and comminuted patella fractures. The aim of this study was to investigate the biomechanical performance of the novel anterior variable-angle locking plates versus tension band wiring used for fixation of simple and complex patella fractures. Sixteen pairs of human cadaveric knees were used to simulate either two-part transverse simple AO/OTA 34-C1 or five-part complex AO/OTA 34-C3 patella fractures by means of osteotomies, with each fracture model created in eight pairs. The complex fracture pattern was characterized with a medial and a lateral proximal fragment, together with an inferomedial, an inferolateral and an inferior fragment mimicking comminution around the distal patellar pole. The specimens with simple fractures were pairwise assigned for fixation with either tension band wiring through two parallel cannulated screws, or an anterior variable-angle locking core plate. The knees with complex fractures were pairwise treated with either tension band wiring through two parallel cannulated screws plus circumferential cerclage wiring, or an anterior variable-angle locking three-hole plate. Each specimen was tested over 5000 cycles by pulling on the quadriceps tendon, simulating active knee extension and passive knee flexion within the range from 90° flexion to full knee extension. Interfragmentary movements were captured by motion tracking. For both fracture types, the articular displacements, measured between the proximal and distal fragments at the central aspect of the patella between 1000 and 5000 cycles, together with the relative rotations of these fragments around the mediolateral axis were all significantly smaller following the anterior variable-angle locked plating compared with the tension band wiring, p < 0.01. From a biomechanical perspective, anterior locked plating of both simple and complex patella fractures provides superior construct stability versus tension band wiring


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 130 - 130
1 Nov 2021
Giorgino R Luca A Ruberto E Besozzi G Banfi G Peretti G
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Introduction and Objective. Over the past few years, a reorganization of the educational pathways has been promoted with the purpose of optimizing the acquisition of competences and their assessment, so as to reduce the risks to both health care professionals and end users. Virtual reality (VR) has been repeatedly tested, initially as a positive reinforcement for more traditional educational pathways and, more recently, as their potential substitute. The aim of this study was to demonstrate the potentiality of VR simulation training in spine surgery. Materials and Methods. The VR simulator reproduced the lateral lumbar access to the spine. The simulation included a tutorial, the preoperative settings, and the surgical session with different levels of procedural complexity. A total of 10 users were recruited for this study: 3 senior surgeons (group A) and 7 orthopedic residents or junior orthopedic surgeons (group B). Each user completed the simulation twice. Results. The user's age or previous experience with VR technology did not show any relevance. On average, the entire simulation was completed in 24 minutes and 36 seconds. Group B showed an improvement between the 2 attempts in both sessions, the preoperative settings and the surgical simulation. The number of major errors dropped from an average of 5.2 to 1.8 and from an average of 4 (1–6) to 1.4, respectively. The simulation was never interrupted because of technical bugs or adverse effects related to the technology. Conclusions. VR-based training pathways might promote a high standard of care. Our preliminary experience suggests an effective implementation of the traditional coaching process


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 45 - 45
1 Nov 2021
Ramirez SC Stoker A Cook J Ma R
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Introduction and Objective. Anterior cruciate ligament reconstruction (ACLR) with tendon autografts is the “gold standard” technique for surgical treatment of ACL injuries. Common tendon graft choices include patellar tendon (PT), semitendinosus/gracilis “hamstring” tendon (HT), or quadriceps tendon (QT). Healing of the graft after ACLR may be affected by graft type since the tissue is subjected to mechanical stresses during post-operative rehabilitation that play important roles in graft integration, remodeling and maturation. Abnormal mechanical loading can result in high inflammatory and degradative processes and altered extracellular matrix (ECM) synthesis and remodeling, potentially modifying tissue structure, composition, and function. Because of the importance of load and ligamentization for tendon autografts, this study was designed to compare the differential inflammatory and degradative metabolic responses to loading by three tendon types commonly used for autograft ACL reconstruction. Materials and Methods. With IRB approval (IRB # 2009879) and informed patient consent, portions of 9 QT, 7 PT and 6 HT were recovered at the time of standard of care ACLR surgeries. Tissues were minced and digested in 0.2 mg/ml collagenase solution for two hours and were then cultured in 10% FBS at 5% CO. 2. , 37°C, and 95% humidity. Once confluent, cells were plated in Collagen Type I-coated BioFlex® plates (1 × 10. 5. cells/well) and cultured for 2 days prior to the application of strain. Then, media was changed to supplemented DMEM with 2% FBS for the application of strain. Fibroblasts were subjected to continuous mechanical stimulation (2-s strain and 10-s relaxation at a 0.5 Hz frequency) at three different elongation strains (mechanical stress deprivation-0%, physiologic strain-4%, and supraphysiological strain-10%). 9. for 6 days using the Flexcell FX-4000T strain system. Media was tested for inflammatory biomarkers (PGE2, IL-8, Gro-α, and MCP-1) and degradation biomarkers (GAG content, MMP-1, MMP-2, MMP-3, TIMP-1, and TIMP-2). Significant (p<0.05) difference between graft sources were assessed with Kruskal-Wallis test and post-hoc analysis. Results are reported as median± interquartile range (IQR). Results. Differences in Inflammation-Related Biomarker Production (Figure 1): The production of PGE2 was significantly lower by HT fibroblasts compared to both QT and PT fibroblasts at all timepoints and strain levels. The production of Gro-α was significantly lower by HT fibroblasts compared to QT at all time points and strain levels, and significantly lower than PT on day 3 at 0% strain, and all strain levels on day 6. The production of IL-8 by PT fibroblasts was significantly lower than QT and HT fibroblast on day 3 at 10% strain. Differences in Degradation-Related Biomarker Production (Figure 2): The production of GAG by HT fibroblasts was significantly higher compared to both QT and PT fibroblasts on day 6 at 0% strain. The production of MMP-1 by the QT fibroblasts was significantly higher compared to HT fibroblasts on day 3 of culture at all strain levels, and in the 0% and 10% strain levels on day 6 of culture. The production of MMP-1 by the QT fibroblasts was significantly higher compared to PT fibroblasts at in the 0% and 4% strain groups on day 3 of culture. The production of TIMP-1 by the HT fibroblasts was significantly lower compared to PT fibroblasts on day 3 of culture. Conclusions. The results of this study identify potentially clinically relevant difference in the metabolic responses of tendon graft fibroblasts to strain, suggesting a lower inflammatory response by hamstring tendon fibroblasts and higher degradative response by quadriceps tendon fibroblasts. These responses may influence ACL autograft healing as well as inflammatory mediators of pain in the knee after reconstruction, which may have implications regarding graft choice and design of postoperative rehabilitation protocols for optimizing outcomes for patients undergoing ACL reconstruction. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_16 | Pages 103 - 103
1 Nov 2018
Jorgensen C
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Adipose derived mesenchymal stromal cells (ASC) are adult stem cells exhibiting functional properties that have open the way for cell-based clinical therapies. Primarily, their capacity of multilineage differentiation has been explored in a number of strategies for skeletal tissue regeneration. More recently, MSCs have been reported to exhibit immunosuppressive as well as healing capacities, to improve angiogenesis and prevent apoptosis or fibrosis through the secretion of paracrine mediators. Among the degenerative diseases associated with aging, osteoarthritis is the most common pathology and affects 16% of the female population over 65 years. Up to now, no therapeutic option exists to obtain a sustainable improvement of joint function beside knee arthroplasty. This prompted us to propose adipose derived stem cells as a possible cell therapy. We performed pre-clinical models of osteoarthritis and showed that a local injection of ASC showed a reduction of synovitis, reduction of osteophytes, joint stabilization, reducing the score of cartilage lesions. This work was completed by toxicology data showing the excellent tolerance of the local injection of ADSC and biodistribution showing the persistence of cells after 6 months in murine models. The aim of the ADIPOA trial is to demonstrate the efficacy of adipose derived stem cells therapy in knee osteoarthritis (OA) in a phase 2/3 controlled multicenter study controlled against standard of care. Safety and feasibility as well as dose response was previously assessed in the ADIPOA FP7 project. The bi-centric phase I clinical trial in Montpellier (France) and Würzburg (Germany) included 18 patients with moderate to severe knee OA, each patient received a single injection of autologous ADSC, in a open scale up dose trial, starting form 2 10 6 cells to 50 106 cells. The 107 dose appears to be well tolerated and showed preliminary response in terms of decreasing local inflammation. This first study confirmed the feasibility and safety of local injection of ADSC in knee OA and suggested the most effective dose (107 autologous ADSC). This work constituted a significant step forward treating this disease with ADSC to demonstrate safety of the procedure. we conduct a prospective multicenter randomized Phase 2/3 study with 86 patients with moderate to severe knee OA to demonstrate superiority of stem cell-based therapy compared to standard of care (SOC) in terms in reduction in clinical symptoms (WOMAC score) and structural benefit (assessed by T1rhoMRI that allow quantification of cartilage proteoglycan content). This project will offer EU a unique leadership in OA with strong positions in EU and US due to patents and quality of the methodology to demonstrate efficiency of ADSC. ADIPOA brings together a unique combination of expertises and leaders in clinical rheumatology, MRI specialists, Stem cell Institutes, national GMP grade adipose derived stem cell production platform (ECELLFRANCE) and SME specialized in cell therapy trials in the EU. The production of the cells will be granted to EFS through ECELLFRANCE national platform, which have the GMP facility and will work as a contracting manufacturing organization. The expertise, leadership and critical mass achieved by this Consortium should enable breakthroughs in ASC engineering directly amenable for clinical applications in OA


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_4 | Pages 86 - 86
1 Mar 2021
Hope N Arif T Stagl A Fawzy E
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Distal radius fractures (DRF) are very common injuries. National recommendations (British Orthopaedic Association, National Institute for Health and Care Excellence (NICE)) exist in the UK to guide the management of these injuries. These guidelines provide recommendations about several aspects of care including which type of injuries to treat non-operatively and surgically, timing of surgery and routine follow-up. In particular, current recommendations include considering immobilizing patients for 4 weeks in plaster for those managed conservatively, and operating on fractures within 72 hours for intra-articular injuries and 7 days for extra-articular fractures. With increased demands for services and an ageing population, prompt surgery for those presenting with distal radius fractures is not always possible. A key factor is the need for prompt surgery for hip fracture patients. This study is an audit of the current standard of care at a busy level 2 trauma unit against national guidelines for the management of DRFs. This retrospective audit includes all patients presenting to our emergency department from June to September 2018. Patients over 18 years of age with a diagnosis of a closed distal radius fracture and follow-up in our department were included in the study. Those with open fractures were excluded. Data was retrieved from clinical coding, electronic patient records, and IMPAX Client (Picture archiving and communication system). The following data was collected on patients treated conservatively and those managed surgically:- (1)Time to surgery for surgical management; (2)Period of immobilization for both conservative and operative groups. 45 patients (13 male, 32 female) with 49 distal radius fractures (2 patients had bilateral injuries) were included. Patients had mean age 63 years (range 19 to 92 years) 30 wrists were treated non-operatively and 19 wrists treated surgically (8 K-wires, 10 ORIF, 1 MUA). Mean time to surgery in the operative group was 8 days (range 1 – 21 days, median 7 days). Mean time to surgery for intra-articular fractures was 7 days (range 1 – 21) and 12 days for extra-articular fractures (range 4 – 20). Mean immobilization period in those treated in plaster is 6 weeks (range 4 – 13 weeks, median 5.6 weeks). At busy level 2 trauma units with limited theatre capacity and a high volume of hip fracture admissions, time to surgery for less urgent injuries such as wrist fractures is often delayed. National guidelines are useful in helping to guide management however their standards are often difficult to achieve in the context of increasing populations in urban areas and an ageing population


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 9 - 9
1 Apr 2017
Wylde V Lenguerrand E Gooberman-Hill R Beswick A Marques E Noble S Horwood J Pyke M Dieppe P Blom A
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Background. Total hip replacement (THR) and total knee replacement (TKR) are usually effective at relieving pain; however, 7–23% of patients experience chronic post-surgical pain. These trials aimed to investigate the effect of local anaesthetic wound infiltration on pain severity at 12 months after primary THR or TKR for osteoarthritis. Methods. Between November 2009 and February 2012, 322 patients listed for THR and 316 listed for TKR were recruited into a single-centre double-blind randomised controlled trial. Participants were randomly assigned (1:1) to receive local anaesthetic infiltration and standard care or standard care alone. Participants and outcomes assessors were masked to group allocation. The primary outcome was pain severity on the WOMAC Pain scale at 12 months post-surgery. Analyses were conducted using intention-to-treat and per-protocol approaches. Ethics approval was obtained from Southampton and South West Hampshire Research Ethics Committee. Results. In the hip trial, patients in the intervention group had significantly less pain at 12 months post-operative than patients in the standard care group (differences in means 4.74; 95% CI 0.95, 8.54; p=0.015), although the difference was not clinically significant. Post-hoc analysis found that patients in the intervention group were more likely to have none to moderate pain than severe pain at 12 months than those in the standard care group (odds ratio 10.19; 95% CI 2.10, 49.55; p=0.004). In the knee trial, there was no strong evidence that the intervention influenced pain severity at 12 months post-operative (difference in means 3.83; 95% CI −0.83, 8.49; p=0.107). Conclusions. In conclusion, routine use of infiltration could be beneficial in improving long-term pain relief for some patients after THR. Level of evidence. Randomised controlled trial. Funding. This article presents independent research funded by the National Institute for Health Research (NIHR) in England under its Programme Grants for Applied Research programme (RP-PG-0407-10070). The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The research team acknowledge the support of the NIHR, through the Comprehensive Clinical Research Network


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 16 - 16
1 Nov 2021
Frydendal T Christensen R Mechlenburg I Mikkelsen LR Overgaard S Ingwersen KG
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Introduction and Objective. Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appear to improve several outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary objective of this trial is to determine the effectiveness of THA followed by standard care compared to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT, on changes in hip pain and function, in patients with severe hip OA after 6 months. Materials and Methods. This is a protocol for a multicentre, parallel-group, assessor blinded, randomised controlled superiority trial. Patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA or PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40-meter fast-paced walk test, 30-second chair stand test, and number of serious adverse events. Results. The trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158) in February 2019 and registration was performed at . ClinicalTrials.gov. (NCT04070027) in August 2019. Recruitment was initiated on the 2. nd. of September 2019 and the final deadline will be on the 30. th. of June 2021, or when a sample size of 120 patients has been accomplished. Conclusions. The results of the current trial are expected to enable evidence-based recommendations, which may be used to facilitate the shared-decision making process in the discussion of treatment strategy for the individual patient with severe hip OA. All results will be presented in peer-reviewed scientific journals and international conferences


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 92 - 92
1 Apr 2017
Smith J Halliday R Aquilina A Hull P Kelly M
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Background. Hip fracture care has evolved, largely due to standardisation of practice, measurement of outcomes and the introduction of the Best Practice Tariff, leading to the sustained improvements documented by the National Hip Fracture Database (NHFD). The treatment of distal femoral fractures in this population has not had the same emphasis. This study defines the epidemiology, current practice and outcomes of distal femoral fractures in four English centres. Methods. 105 patients aged 50 years or greater with a distal femoral fracture, presenting to four UK major trauma centres between October 2010 and September 2011 were identified. Data was collected using an adapted NHFD data collection tool via retrospective case note and radiograph review. Local ethics approval was obtained. Results. Mean age was 77 years (range 50–99), with 86% female. 95% of injuries were sustained from a low energy mechanism, and 72% were classified as either 33-A1 or 33-C1. The mean Parker mobility score and Barthel Independence Index were 5.37 (0–9) and 75.5 (0–100) respectively. Operative management was performed in 84%, and 86% had their surgery within 36 h. Three quarters were fixed with a peri-articuar locking plate. There was no consensus on post operative rehabilitation, but no excess of complications in the centres where weight bearing as tolerated was the standard. 45% were seen by an orthogeriatrician during their admission. Mean length of stay was 29 days. Mortality at 30 days, 6 months, and 1 year was 7%, 16% and 18% respectively. Conclusions. This study demonstrates that the distal femoral and hip fracture populations are similar, and highlights the current disparity in their management. The metrics and standards of care currently applied to hip fractures should be applied to the treatment of distal femoral fractures. Optimal operative treatment and rehabilitation remains unclear, and further research is in progress. Level of evidence. 2b. Ethics. Local approval was obtained


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 119 - 119
1 Jan 2017
Beswick A Wylde V Marques E Lenguerrand E Gooberman-Hill R Noble S Pyke M Blom A
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Robust evidence on the effectiveness of peri-operative local anaesthetic infiltration (LAI) is required before it is incorporated into the pain management regimen for patients receiving total hip replacement (THR). We assessed the effectiveness of LAI using a systematic review and a fully powered randomised controlled trial (RCT) with economic evaluation. We searched MEDLINE, Embase and Cochrane databases for RCTs of peri-operative LAI in patients receiving THR. Two reviewers screened abstracts, extracted data, and liaised with authors. Outcomes were pain, opioid use, mobilisation, hospital stay and complications. If feasible, we conducted meta-analysis. In the APEX RCT, we randomised 322 patients awaiting THR to receive additional peri-operative LAI (60mls 0.25% bupivacaine plus adrenaline) or standard anaesthesia alone. Post-operatively, all patients received patient-controlled morphine. The primary outcome was joint pain severity (WOMAC-Pain) at 12 months. Patients and outcome assessors were blinded to allocation. Within APEX, cost-effectiveness was assessed from the health and social-care perspective in relation to quality adjusted life years (QALYs) and WOMAC-Pain at 12-months. Resource use was collected from hospital records and patient questionnaires. In the systematic review, we identified 13 studies (909 patients). Patients undergoing THR receiving LAI experienced greater pain reduction at 24 hours at rest, standardised mean difference (SMD) −0.61 (95%CI −1.05, −0.16; p=0.008) and at 48 hours during activity, SMD −0.43 (95%CI −0.78, −0.09; p=0.014). Patients receiving LAI spent fewer days in hospital, used less opioids and mobilised earlier. Complications were similar between groups. Long-term outcomes were not a focus of these studies. In the APEX RCT, pain levels in hospital were broadly similar between groups, probably due to patient-controlled analgesia. Opioid use was similar between groups. Time to mobilisation and discharge were largely dependent on local protocols and did not differ between groups. Patients receiving LAI were less likely to report severe pain at 12 months than those receiving standard care, odds ratio 10.2 (95%CI 2.1, 49.6; p=0.004). Complications were similar between groups. In the economic evaluation, LAI was associated with lower costs and greater cost-effectiveness than standard care. Using a £20,000 per QALY threshold, the incremental net monetary benefit was £1,125 (95%CI £183, £2,067) and the probability of being cost-effective was greater than 98 %. The evidence suggests that peri-operative LAI is a cost-effective intervention for reducing acute and chronic post-surgical pain after THR


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 70 - 70
1 Jan 2017
Wylde V Marques E Artz N Blom A Gooberman-Hill R
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Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times for THR can be considerable, and patients often experience significant pain during this time. A pain self-management intervention may provide patients with the skills to enable them to manage their pain and its impact more effectively before surgery. However, studies of arthritis self-management programmes have faced challenges because of low recruitment rates, poor intervention uptake, and high attrition rates. This study aimed to evaluate the feasibility of a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Specific objectives were to assess trial design, ascertain recruitment and retention rates, identify barriers to participation, refine data collection methods, and evaluate uptake and patient satisfaction with the course. Patients listed for THR in an elective orthopaedic centre Bristol, UK were sent a postal invitation about the study. Participants were randomised to attend a pain self-management course plus standard care or standard care only using a computer-generated randomisation system. The pain self-management course was delivered by Arthritis Care and consisted of two half-day group sessions prior to surgery and one full-day group session 2–4 months after surgery. A structured course evaluation questionnaire was completed by participants. Outcomes assessment was by postal questionnaire prior to surgery and 1-month, 3-months and 6-months after surgery. Self-report resource use data were collected using a diary prior to surgery and inclusion of resource use questions in the 3-month and 6-month post-operative questionnaires. Brief telephone interviews were conducted with non-participants to explore barriers to participation. Postal invitations were sent to 385 eligible patients and 88 patients consented to participate (23% recruitment rate). Participants had a mean age of 66 years and 65% were female. Brief interviews with 57 non-participants revealed the most common reasons for non-participation were perceptions about the intervention and difficulties in getting to the hospital for the course. Of the 43 patients randomised to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and patients enjoyed the group format. Retention of participants was acceptable, with 83% completing follow-up. Questionnaire return rates were high (76–93%), with the exception of the pre-operative resource use diary (35%). Completion rates for the resource use questions varied by category and allowed for an economic perspective from the health and social care payer to be taken. Undertaking feasibility work for a RCT is labour-intensive; however this study highlights the importance of conducting such work. Postal recruitment resulted in a low recruitment rate and brief interviews with non-participants provided valuable information on barriers to participation. Embedding collection of resource use data within questionnaires resulted in higher completion rates than using resource use diaries. While patients who attended the course gave positive feedback, attendance was low. Findings from this feasibility study enable us to design successful definitive group-based RCTs in the future


Bone & Joint 360
Vol. 11, Issue 3 | Pages 46 - 47
1 Jun 2022
Das A


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 36 - 36
1 Jul 2014
Segal D Estrada R Pasion M Ramos R Stark Y Gustilo R Emanuel N
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Purpose. Gustilo type III open fractures are associated with high infection rates in spite of instituting a standard of care (SOC) consisting of intravenous antibiotics, irrigation and debridement (I&D), and delayed wound closure. Locally-delivered antibiotic has been proven to assist in reducing infection in open fractures. The aims of this study are to determine the effectiveness and safety of a new implantable and biodegradable antibacterial product. 1. in preventing bacterial infections and initiating bone growth in open fractures. Methods. The osteoconductive antibacterial BonyPid. TM. used is a synthetic bone void filler (comprised of ≤1 mm β-tricalcium phosphate granules) coated by a thin layer (≤20 µm) of PolyPid nanotechnology formulation. −. Upon implantation, the coating releases doxycycline at a constant rate for a predetermined period of 30 days. One BonyPid. TM. vial of 10 grams contains 65 mg of formulated doxycycline. After approval, sixteen subjects with Gustilo type III open tibia fractures, were implanted with the BonyPid. TM. immediately on the first surgical intervention (I&D), followed by external fixation. Patients had periodic laboratory, bacteriology and radiology follow-up. Results. Six months results showed that no infection developed and only one BonyPid. TM. implantation was needed with no subsequent I&D, in the target tibia fracture. Immediate soft wound closure was done in 6/16 subjects following implantation. Out of 10 remaining subjects, 3 needed soleus muscle transfer-skin grafting and 7 required delayed primary closure; by skin grafting (5) or suturing (2). Early callus formation was seen at 8–12 weeks post-surgery, followed by bone healing seen from 16 weeks onwards. Safety of implantation was remarkable, with only one deep infection at a fibular open fracture without BonyPid. TM. implantation. One BonyPid. TM. -related adverse event caused delay in skin healing due to excessive granules in the superficial soft tissues. Conclusion. BonyPid. TM. is effective in reducing bone infection and promoting early callus formation, resulting in early bone healing. BonyPid. TM. is safe for immediate implantation into contaminated/infected severe open-bone fractures. Results support that one month release of doxycycline in a controlled manner provides an effective way for treating open fractures. This new local antibiotic delivery system is applicable in unmet medical situations associated with localised infections


Bone & Joint 360
Vol. 11, Issue 1 | Pages 50 - 51
1 Feb 2022
Das A


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 75 - 75
1 Jul 2014
Farinella G Viceconti M Schileo E Falcinelli C Yang L Eastell R
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Summary. A retrospective study on 98 patients shows that FE-based bone strength from CT data (using validated FE models) is a suitable candidate to discriminate fractured versus controls within a clinical cohort. Introduction. Subject-specific Finite element models (FEM) from CT data are a promising tool to non-invasively assess the bone strength and the risk of fracture of bones in vivo in individual patients. The current clinical indicators, based on the epidemiological models like the FRAX tool, give limitation estimation of the risk of femoral neck fracture and they do not account for the mechanical determinants of the fracture. Aim of the present study is to prove the better predictive accuracy of individualised computer models based a CT-FEM protocol, with the accuracy of a widely used standard of care, the FRAX risk indicator. Patients and Methods. This retrospective cohort is individually-matched case control study composed by 98 Caucasian women who were at least 5 years post menopause. The case group consisted of 49 patients who had sustained a hip fracture (36 intra-capsular and 13 extra-capsular fractures) within the previous 90 days due to low-energy trauma. The CT datasets were segmented (using the ITK-Snap software) in order to extract the periosteal bone surface. Unstructured meshes (10-node tetrahedral elements) were generated using ANSYS mesh morphing software. Each CT dataset was calibrated using the European Spine Phantom. The inhomogeneous material properties were mapped from CT datasets into the FEM with the BoneMat_V3 software. Bone strength was evaluated in quasi-axial loading conditions, for a set of 12 different configurations sampling the cone of recorded in vivo hip joint reactions, and was defined as the minimum load inducing on the femoral neck surface an elastic principal strain value greater than a limit value. Results. There were no statistically significant difference between the fracture and the control groups for age, height and weight (p<0.05). All indices of areal bone mineral density (aBMD) and the volumetric mineral density (vBMD) between fractured and controls showed on average a lower value for fractured respect of the controls, with similar mean difference (14% for aBMD and 13% for the vBMD). FEM-predicted strength differed between fractured and non-fractured on average for 20%. To evaluate its ability to identify patients at risk of hip fracture, FEM-based strength was compared to the FRAX predictor by computing for each predictor the Receiver Operating Characteristic (ROC) curve, and the Area Under the Curve (AUC). The individualised risk predictor based on FEM bone strength was found to perform significantly better (AUC=0.76) than FRAX (AUC=0.66). When the FEM-based strength indicator was combined with available clinical information in a logistic regression, the resulting predictor achieved in this retrospective study an excellent accuracy (AUC=0.82). Discussion. This study confirms that individualised, CT- FEM, when generated using to the state-of-the-art protocols, can provide a predictor of the risk of hip fracture more accurate than those based on clinical data alone. In the integrated workflow developed in the VPHOP Project (FP7-ICT-223865) CT-based risk prediction is requested only for those patients for whom the clinical decision is uncertain


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_3 | Pages 12 - 12
1 Apr 2018
Marques EM Blom AW Erik L Vikki W Sian N
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Background. The Arthroplasty Pain Experience (APEX) studies are two randomised controlled trials in primary total hip (THR) and knee replacement (TKR) at a large UK orthopaedics centre. APEX investigated the effect of local anaesthetic wound infiltration (LAI), administered before wound closure, in addition to standard analgesia, on pain severity at 12 months. This abstract reports results of the within-trial economic evaluations. Methods. Cost-effectiveness was assessed from the health and social care payer perspective in relation to quality adjusted life years (QALYs). Resource use was collected from hospital records and patient-completed postal questionnaires, and valued using unit cost estimates from local NHS Trust and national tariffs. Missing data were imputed using chained equations. Costs and outcomes were compared per trial arm and plotted in cost-effectiveness planes. The economic results were bootstrapped incremental net monetary benefit statistics (INMB) and cost-effectiveness acceptability curves. One-way deterministic sensitivity analyses explored any methodological uncertainty. Results. In both trials, LAI was cost-saving and more effective than standard care. Using the £20,000 per QALY threshold, in THR, the INMB was £1,125 (95%BCI, £183 to £2,067) and the probability of being cost-effective was over 98%. In TKR, the INMB was £264 (95%BCI, −£710 to £1,238), with only 62% probability of being cost-effective. Considering an NHS perspective only, LAI was no longer dominant in THR, but still highly cost-effective, with an INMB of £961 (95%BCI, £50 to £1,873). Conclusions. Administering LAI is a cost-effective treatment option in THR and TKR surgeries. The evidence is stronger for THR, because of larger QALY gain. In TKR, there is more uncertainty around the economic result, and smaller QALY gains, but results point to LAI being cheaper than standard analgesia, which includes a femoral nerve block. Trial Registration. ISRCTN96095682, 29/04/2010. Funding. NIHR Programme Grant for Applied Research RP-PG-0407-10070


Bone & Joint 360
Vol. 10, Issue 1 | Pages 45 - 46
1 Feb 2021
Das A


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVIII | Pages 53 - 53
1 Jun 2012
Murray O Christen K Marsh A Bayer J
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Current fracture-clinic models, especially in the advent of reductions in junior doctors hours, may limit outpatient trainee education and patient care. We designed a new model of fracture-clinic, involving an initial consultant led case review focused on patient management and trainee education. Outcomes for all new patients attending the redesigned fracture-clinic over a 3-week period in 2010 were compared with the traditional clinic in the same period in 2009. Health professionals completed a Likert questionnaire assessing their perceptions of education, support, standards of patient care and morale before and after the clinic redesign. 309 and 240 patients attended the clinics in 2009 and 2010 respectively. There was an increase in consultant input into patient management after the redesign (29% versus 84%, p<0.0001), while the proportion of patients requiring physical review by a consultant fell (32% versus 9%). The percentage of new patients discharged by junior medical staff increased (17% versus 25%) with a reciprocal fall in return appointments (55% versus 40%, p<0.0005). Overall, return appointment rates fell significantly (55% versus 40%, p=0.013). Staff perception of education and senior support improved from 2 to 5, morale and overall perception of patient care from 4 to 5. Our model of fracture-clinic redesign has significantly enhanced consultant input into patient care without additional funding. In addition, we have demonstrated increased service efficiency and significant improvements in staff support, morale and education. In the face of current economic and training challenges, we recommend this new model as a tool for enhancing patient and trainee experiences


Bone & Joint 360
Vol. 7, Issue 6 | Pages 41 - 42
1 Dec 2018
Das A


Bone & Joint 360
Vol. 7, Issue 6 | Pages 43 - 44
1 Dec 2018
Foy MA