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Bone & Joint Research
Vol. 3, Issue 5 | Pages 161 - 168
1 May 2014
Mundi R Chaudhry H Mundi S Godin K Bhandari M

High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding.

Cite this article: Bone Joint Res 2014;3:161–8.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 85 - 85
1 Jan 2016
Goh S Chua K Chong D Yew A Lo NN
Full Access

Introduction

Total hip replacement is an established surgical procedure done to alleviate hip pain due to joint diseases. However, this procedure is avoided in yonger patients with higher functional demands due to the potential for early failure. An ideal prosthesis will have have a high endurance against impact loading, with minimal micromotion at the bone cement interface, and a reduced risk of fatigue failure, with a favourable stress distribution pattern in the femur. We study the effect of varying the material properties and design element in a standard cemented total hip using Finite Element Analysis.

Methods

A patient-specific 3D model of femur will be constructed from CT scan data, while a Summit® Cemented Hip System (DePuy Orthopedic) will be used to as a control for comparative evaluation. We vary the material stiffness of different parts of the prosthesis(see Fig.1) to formulate a design concept for a new total hip prosthesis design; and use Finite Element Method to predict the micromotion of the hip prosthesis at the bone cement interface, as well as the stress distribution in the the femur.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 36 - 36
23 Feb 2023
Ma N Gogos S Moaveni A
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Surgical site infections following orthopaedic surgery are a serious complication associated with increased morbidity and mortality. Intra-wound antibiotic powder may be able to provide infection prophylaxis locally with less systemic adverse effects, and promising results have been reported in systematic reviews of its use in spine surgery. This study aims to analyse the efficacy and adverse effect profile of intra-wound antibiotics in reducing surgical site infections in orthopaedic surgery for traumatic pelvic and lower limb fractures. A systematic review was conducted for studies reporting on the incidence of surgical site infections following administration of intra-wound antibiotic powder in pelvic and lower limb trauma surgery. Randomised controlled trials, cohort and case-control studies were included. A meta-analysis was conducted for deep surgical site infections. Seven studies were included in the systematic review including six retrospective case-control studies and one randomised controlled trial. Results of the meta-analysis suggest a potential 23% reduction in the odds of developing a deep surgical site infection in patients treated with intra-operative antibiotic powder compared with those managed with intravenous antibiotics alone (OR 0.77, 95% CI 0.52 – 1.13), although the results did not reach statistical significance. Notable selective bias against intra-wound antibiotics and suboptimal study design were found in the retrospective studies, however the randomised controlled trial reported a significant reduction in deep surgical site infections with intra-wound vancomycin powder. There were no reports of systemic adverse outcomes and minimal risk of wound complications with the use of intra-wound antibiotics. This review suggests the use of intra-wound antibiotic powder in pelvic and lower limb trauma surgery may reduce the incidence of deep surgical site infections. Further powered studies including randomised controlled trials are required to confirm the results highlighted in this study


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_10 | Pages 39 - 39
1 Jun 2023
Chandra A Trompeter A
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Atypical femoral fracture non-union (AFFNU) is both, rare (3–5 per 1000 proximal femur fractures) and difficult to treat. Lack of standardised guidelines leads to a variability in fixation constructs, use of bone grafting and restricted weight bearing protocols, which are not evidence based. We hypothesised that there is no change in union rates without the use of bone grafting and immediate weight bearing post-operatively does not lead to increased complications. Materials & Methods. A retrospective review of all consecutively treated AFFNU cases between March 2015 to December 2019 was carried out. 9 patients with a mean age of 63.87 years and M:F ratio of 7:2 met the inclusion criteria. Primary outcome variable was radiographic union at 12 months after revision surgery. All surgeries were carried out by a single surgeon. Fixation construct, neck-shaft angle, use of bone graft and immediate postoperative weight bearing protocols were recorded. Results. Radiographic union was achieved in 7 of 9 patients (78%) after first revision surgery. 1 patient achieved union after 2nd revision surgery and 1 patient died in the early post-operative period due to pulmonary embolism. No bone grafting was used in any of the patients and weight-bearing as tolerated was allowed from the first post-operative day. The mean neck-shaft angle after non-union surgery was 136 degrees. Conclusions. In this case series, the union rate was comparable to those reported in literature previously and achieved without any form of bone grafting. To our knowledge, this is the only case series where no bone grafting was used in the management of AFFNU. Limited by a small sample size and retrospective study design, still, this study brings into question the efficacy of practice of bone grafting and restricted weight-bearing in the management of AFFNU. Bone grafting is associated with the risk of infection at donor site, postoperative pain, and morbidity, while early weight bearing is critical in elderly patients. There is no evidence supporting restricted weight-bearing and it should not be adopted as the default practice as it may even be detrimental to patients


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_11 | Pages 4 - 4
1 Nov 2022
Adapa A Shetty S Kumar A Pai S
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Abstract. Background. Fractures Proximal humerus account for nearly 10 % of geriatric fractures. The treatment options varies. There is no consensus regarding the optimal treatment, with almost all modalities giving functionally poor outcomes. Hence literature recommends conservative management over surgical options. MULTILOC nail with its design seems to be a promising tool in treating these fractures. We hereby report our early experience in the treatment of 37 elderly patients. Objectives. To evaluate the radiological outcome with regards to union, collapse, screw back out/cut through, implant failures, Greater tuberosity migration. To evaluate the functional outcome at the end of 6 months using Constant score. Study Design & Methods. All patients aged >65 years who underwent surgery for 3,4-part fracture proximal humerus using the MULTILOC nail were included in the study after consent. Pre – existing rotator cuff disease were excluded. Within the time frame, a total of 39 patients underwent the said surgery. 2 patients were lost to follow up. All the measurements were taken at the end of 6 months and results tabulated and analysed. Results. Union was achieved in all the 37 patients. There were no varus collapse or screw backout/cut through seen in any of the patients. There was Greater tuberosity migration in 1 patient who underwent revision surgery at 6 weeks. All the patients got a minimum of 70 degrees of abduction and forward flexion. We had 29 excellent, 6 good, 2 fair and none poor results as per Constant scoring system. Study done in Tejasvini Hospital & SSIOT Mangaluru India


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_14 | Pages 3 - 3
23 Jul 2024
Kimber E Allman J Dasic D Wong F McCarthy M
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Study design. Retrospective study. Objectives. To identify patient outcomes, in particular employment, >5-years following traumatic thoracolumbar fracture. Methods. 235 patients between the ages of 18–65 were identified from the hospital radiology database having sustained a traumatic thoracolumbar fracture on CT or MRI between 01/01/2013 and 31/01/2017. Questionnaires were sent out via post and available emails, with a reminder letter and phone calls. Retrospective data was gathered about employment status pre-fracture and >5-years post injury. Results. 26 patients had died at follow up leaving 209 patients. 108 (52%) were treated surgically and 101 (48%) conservatively. 106 replies were received with 85 (80%) opting in and 21 (20%) opting out. 68 (80%) patients completed the full questionnaire with 17 (20%) filling out a shortened questionnaire via a phone conversation. 52 (61%) patients underwent surgery and 33 (39%) were treated conservatively. The average follow up was 8 years. Prior to injury 66 (78%) were employed and 19 (22%) unemployed (of which 6 were full time students and 8 were retired). 49 (74%) of the previously employed patients returned to work at follow up with 35 (53%) working the same or increased hours. Regarding employment, there was no significant difference between surgically and conservatively treated patients (P=0.355) or the classification of the fracture (P=0.303). 16 (19%) patients reported back pain prior to their injury whilst 69 (81%) did not. There were 58 (68%) cases of new pain at follow up with the most affected area being the lumbar region in 43 (51%) patients. 32 (38%) patients reported neurological deficit post injury: 19 with subjective symptoms, 9 with objective symptoms and 4 suffered paralysis. Conclusion. >5-years following a traumatic thoracolumbar fracture most individuals return to employment. There was no significant difference between the severity of the fracture or how patients are treated on their employment outcomes


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 63 - 63
1 Dec 2022
Hoffer A Kingwell D Leith J McConkey M Ayeni OR Lodhia P
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Over half of postpartum women experience pelvic ring or hip pain, with multiple anatomic locations involved. The sacroiliac joints, pubic symphysis, lumbar spine and pelvic girdle are all well documented pain generators. However, despite the prevalence of postpartum hip pain, there is a paucity of literature regarding underlying soft tissue intra-articular etiologies. The purpose of this systematic review is to document and assess the available evidence regarding underlying intra-articular soft tissue etiologies of peri- and postpartum hip pain. Three online databases (Embase, PubMed and Ovid [MEDLINE]) were searched from database inception until April 11, 2021. The inclusion criteria were English language studies, human studies, and those regarding symptomatic labral pathology in the peri- or postpartum period. Exclusion criteria were animal studies, commentaries, book chapters, review articles and technical studies. All titles, relevant abstracts and full-text articles were screened by two reviewers independently. Descriptive characteristics including the study design, sample size, sex ratio, mean age, clinical and radiographic findings, pathology, subsequent management and outcomes were documented. The methodological quality of the included studies was assessed using the Methodological Index for Non-Randomized Studies (MINORS) instrument. The initial search identified 2472 studies. A systemic screening and assessment of eligibility identified 5 articles that satisfied the inclusion criteria. Twenty-two females were included. Twenty patients presented with labral pathology that necessitated hip arthroscopy with labral debridement or repair with or without acetabuloplasty and/or femoroplasty. One patient presented with an incidental labral tear in the context of osteitis condensans illi. One patient presented with post-traumatic osteoarthritis necessitating a hip replacement. The mean MINORS score of these 5 non-comparative studies was 2.8 (range 0-7) demonstrating a very low quality of evidence. The contribution of intra-articular soft tissue injury is a documented, albeit sparse, etiology contributing to peri- and postpartum hip pain. Further research to better delineate the prevalence, mechanism of injury, natural history and management options for women suffering from these pathologies at an already challenging time is necessary to advance the care of these patients


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 99 - 99
1 Dec 2022
Morrison L Abbott A Mack Z Schneider P Hiemstra LA
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The number of women entering medical school has been steadily increasing over the past two decades; however, the number of women pursuing careers in orthopaedic surgery has not increased at the same rate. One of the suggested reasons for this discrepancy is the perceived incompatibility of having a family while upholding the demands of a surgical career in orthopaedics. A growing body of scientific literature has also outlined the increased rate of infertility and pregnancy complications in women surgeons. The extent to which these factors play a role in the recruitment and retention of women in orthopaedic surgery is unknown. Understanding pregnancy and parenthood in orthopaedic surgery is a critical first step in addressing this issue. A scoping review was conducted to identify literature pertaining to the perceptions and experiences of pregnancy and/or parenthood of women in orthopaedic surgery. Embase, MEDLINE and PsychINFO were searched on June 7th, 2021 with Boolean operators to combine the following terms: orthop?e*, pregnancy, maternity, motherhood, parenthood, parental, and parenting. Studies pertaining to orthopaedic surgery residents, fellows and staff were included. The Arksey and O'Malley framework for scoping studies was followed. Descriptive statistics were used to quantify the included studies while thematic analysis as described by Braun and Clarke was used to analyze the qualitative data. A total of 17 studies from 2006 to 2021 met inclusion criteria. Over half of the available research was conducted within the last two years (n=9, 53%). The majority of studies were conducted in the United States (n=15, 88%) and the United Kingdom (n=2, 12%). The most commonly used study design was survey-based research (n=13, 76%), followed by review studies (n=3, 18%), and case series (n=1, 6%). Thematic analysis revealed five key themes contributing to the women's experiences of pregnancy and/or parenthood in orthopaedics: (1) women are subtly or blatantly discouraged from becoming pregnant by their colleagues and superiors, (2) women delay childbearing to preserve their professional reputation, (3) there are higher rates of infertility and preterm labor in orthopaedic surgeons than in the general population, (4) the orthopaedic work environment can be hazardous and challenging for the pregnant woman, but accommodations are possible to mitigate risks, and (5) overall, there is limited support for pregnant and/or parenting women in orthopaedics throughout their career. The first woman to be board-certified in orthopaedic surgery in the United States was Ruth Jackson in 1937. Eighty-four years later, orthopaedic surgery has the lowest number of women of the surgical specialties. The barriers related to pregnancy and/or parenthood during a woman's career in orthopaedics may be one cause. This study identified five themes related to pregnancy and parenthood that warrant further investigation. Qualitative research approaches can be used to elucidate the details of women's experiences and to provide suggestions for structural changes in the orthopaedic work environment


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 22 - 22
10 Feb 2023
Horn A Cetner C Laubscher M Tootlah H
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Osteoarticular infections (OAI) are a common cause of morbidity in children, and as opposed to adults is usually caused by haematogenous spread. The bacteriology of OAI in children is not well described in the South African context, therefore this study was designed to determine the bacteriology of OAI in our population. All patients that underwent surgery for the treatment of OAI over a 3-year period were identified and those with positive cultures where organisms were identified from tissue, pus, fluid or blood were included. Duplicate cultures from the same patient were excluded if the organism and antibiotic susceptibility profile was the same. Patients were categorised according to age and class of infection (Septic arthritis, acute osteomyelitis, fracture related infection, post-operative sepsis and chronic osteomyelitis) and organisms were stratified according to these categories. We identified 132 organisms from 123 samples collected from 86 patients. Most cultured organisms were from children older than 3-years with acute haematogenous septic arthritis, osteomyelitis, or both. Methicillin sensitive Staphylococcus aureus accounted for 56% (74/132) of organisms cultured. There were no cases of MRSA. The Enterobacterales accounted for 17% (22/132) of organisms cultured, mostly in the fracture related and post-operative infection groups. Of these, 6 each were extended spectrum B-lactamase producers and AmpC producers. There were no carbapenemase producing Enterobacterales. Kingella kingae was not isolated in any patient. Methicillin sensitive S. aureus is the most common infecting organism in paediatric OAI and an anti-staphylococcal penicillin such as cloxacillin or flucloxacillin is the most appropriate empiric treatment for haematogenous OAI in our environment. In fracture related or post-operative infections, Enterobacterales were more frequently cultured, and treatment should be guided by culture and susceptibility results


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 98 - 98
23 Feb 2023
Woodfield T Shum J Tredinnick S Gadomski B Fernandez J McGilvray K Seim H Nelson B Puttlitz C Easley J Hooper G
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Introduction: The mechanobiology and response of bone formation to strain under physiological loading is well established, however investigation into exceedingly soft scaffolds relative to cancellous bone is limited. In this study we designed and 3D printed mechanically-optimised low-stiffness implants, targeting specific strain ranges inducing bone formation and assessed their biological performance in a pre-clinical in vivo load-bearing tibial tuberosity advancement (TTA) model. The TTA model provides an attractive pre-clinical framework to investigate implant osseointegration within an uneven loading environment due to the dominating patellar tendon force. A knee finite element model from ovine CT data was developed to determine physiological target strains from simulated TTA surgery. We 3D printed low-stiffness Ti wedge osteotomy implants with homogeneous stiffness of 0.8 GPa (Ti1), 0.6 GPa (Ti2) and a locally-optimised design with a 0.3 GPa cortex and soft 0.1 GPa core (Ti3), for implantation in a 12-week ovine tibial advancement osteotomy (9mm). We quantitatively assessed bone fusion, bone area, mineral apposition rate and bone formation rate. Optimised Ti3 implants exhibited evenly high strains throughout, despite uneven wedge osteotomy loading. We demonstrated that higher strains above 3.75%, led to greater bone formation. Histomorphometry showed uniform bone ingrowthin optimised Ti3 compared to homogeneous designs (Ti1 and Ti2), and greater bone-implant contact. The greatest bone formation scores were seen in Ti3, followed by Ti2 and Ti1. Results from our study indicate lower stiffness and higher strain ranges than normally achieved in Ti scaffolds stimulate early bone formation. By accounting for loading environments through rational design, implants can be optimised to improve uniform osseointegration. Design and 3D printing of exceedingly soft titanium orthopaedic implants enhance strain induced bone formation and have significant importance in future implant design for knee, hip arthroplasty and treatment of large load-bearing bone defects


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 38 - 38
1 Feb 2021
Hickey M Anglin C Masri B Hodgson A
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Introduction. Innovations in surgical robotics and navigation have significantly improved implant placement accuracy in total knee arthroplasty (TKA). However, many comparative studies have not been shown to substantially improve revision rates or other clinical outcome scores. We conducted a simulation study based on the reported distribution of patient-specific characteristics and estimated potential effect of coronal plane alignment (CPA) on risk of revision to evaluate the hypothesis that most published study designs in this area have been too underpowered to detect improvements in revision rates. Methods. To model previously reported studies, we generated a series of simulated TKA patient populations, assigning each patient a set of patient-specific factors (age at index surgery, BMI, and sex (Fig.1a)), as well as one surgeon-controlled factor (CPA) (Fig.1b) based on registry data and published literature. We modelled the survival probability for an individual patient at time t as a Gaussian function (exp[-(t/(k∗τ. max. )). 2. ]), where τ. max. (99.5 years) is selected to ensure the mean survival probability of the patient population matched 92% at 15 years. The value of k was adjusted for simulated patients within a range of 0 to 1 as a function of their patient and surgeon-specific factors (Fig.2). To evaluate power associated with a study design, we ran a Monte Carlo simulation generating 10,000 simulated populations of ten different cohort sizes. We divided the patient population into two groups: one group was assigned CPAs governed by the precision of a navigated/robotic approach (σ=1.5°), and the other CPAs governed by the precision of a conventional approach (σ=3°). We then simulated the time to failure for each patient, computed the corresponding Kaplan-Meier survival curves, and applied a Log-Rank test to each study to test for statistical difference. From the 10,000 simulations associated with each cohort size, we determined the percentage of simulated studies that found a statistically significant difference at each time point. Results. Figure 3 shows a contour plot illustrating the probability that a survival analysis with a specific study design would find statistical significance between the conventional and navigated/robotic patient groups. Entries from recently published literature are overlaid for context. No studies achieved statistical significance (p<0.05). Discussion. The effectiveness of navigated/robotic surgery is one of the most controversial debates in orthopedic surgery. The results from this simulation suggest that most revision studies aiming to settle this debate are likely significantly underpowered, falling below the normal 80% threshold. Limitations of this analysis include using only a single surgeon-controlled variable in the survival simulation, and only a single precision for the navigated/robotic approaches. Further studies will include more implant-related risk factors and a wider range of precisions for navigated/robotic procedures. Based on this simulation, it appears the effect size afforded by navigated/robotic surgeries on revision rates in TKA surgery is too small to recommend broad application, especially since adoption could involve added costs and unforeseen risks associated with novelty. Clinically, it may be beneficial to examine the use of robotics/navigation on high-risk patients, where studies are likely to have higher power due to larger effect sizes. For any figures or tables, please contact the authors directly


Bone & Joint Open
Vol. 3, Issue 5 | Pages 359 - 366
1 May 2022
Sadekar V Watts AT Moulder E Souroullas P Hadland Y Barron E Muir R Sharma HK

Aims. The timing of when to remove a circular frame is crucial; early removal results in refracture or deformity, while late removal increases the patient morbidity and delay in return to work. This study was designed to assess the effectiveness of a staged reloading protocol. We report the incidence of mechanical failure following both single-stage and two stage reloading protocols and analyze the associated risk factors. Methods. We identified consecutive patients from our departmental database. Both trauma and elective cases were included, of all ages, frame types, and pathologies who underwent circular frame treatment. Our protocol is either a single-stage or two-stage process implemented by defunctioning the frame, in order to progressively increase the weightbearing load through the bone, and promote full loading prior to frame removal. Before progression, through the process we monitor patients for any increase in pain and assess radiographs for deformity or refracture. Results. There were 244 frames (230 patients) included in the analyses, of which 90 were Ilizarov type frames and 154 were hexapods. There were 149 frames which underwent single-stage reloading and 95 frames which underwent a two-stage reloading protocol. Mechanical failure occurred after frame removal in 13 frames (5%), which suffered refracture. There were no cases of change in alignment. There was no difference between refracture patients who underwent single-stage or two-stage reloading protocols (p = 0.772). In all, 14 patients had failure prevented through identification with the reloading protocol. Conclusion. Our reloading protocol is a simple and effective way to confirm the timing of frame removal and minimize the rate of mechanical failure. Similar failure rates occurred between patients undergoing single-stage and two-stage reloading protocols. If the surgeon is confident with clinical and radiological assessment, it may be possible to progress directly to stage two and decrease frame time and patient morbidity. Cite this article: Bone Jt Open 2022;3(5):359–366


Bone & Joint Open
Vol. 1, Issue 10 | Pages 628 - 638
6 Oct 2020
Mott A Mitchell A McDaid C Harden M Grupping R Dean A Byrne A Doherty L Sharma H

Aims. Bone demonstrates good healing capacity, with a variety of strategies being utilized to enhance this healing. One potential strategy that has been suggested is the use of stem cells to accelerate healing. Methods. The following databases were searched: MEDLINE, CENTRAL, EMBASE, Cochrane Database of Systematic Reviews, WHO-ICTRP, ClinicalTrials.gov, as well as reference checking of included studies. The inclusion criteria for the study were: population (any adults who have sustained a fracture, not including those with pre-existing bone defects); intervention (use of stem cells from any source in the fracture site by any mechanism); and control (fracture healing without the use of stem cells). Studies without a comparator were also included. The outcome was any reported outcomes. The study design was randomized controlled trials, non-randomized or observational studies, and case series. Results. In all, 94 eligible studies were identified. The clinical and methodological aspects of the studies were too heterogeneous for a meta-analysis to be undertaken. A narrative synthesis examined study characteristics, stem cell methods (source, aspiration, concentration, and application) and outcomes. Conclusion. Insufficient high-quality evidence is available to determine the efficacy of stem cells for fracture healing. The studies were heterogeneous in population, methods, and outcomes. Work to address these issues and establish standards for future research should be undertaken. Cite this article: Bone Joint Open 2020;1-10:628–638


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_14 | Pages 93 - 93
1 Dec 2019
Jensen LK Henriksen NL Blirup SA Jensen HE
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Aim. To conduct a systematic review of non-rodent animal models (rabbit, pig, dog, goat and sheep) of bone infection. In the future, anti-infective technologies aiming to fight bone infections are depending on evaluation in reliable animal models. Therefore, it is highly relevant to evaluate the scientific quality of existing bone infection models. Method. PubMed and Web of Science were searched systematically. To be included in the systematic review, publications had to deal with bacterial inoculation of non-rodent animals in order to model bone infections in humans. Data was extracted on study design e.g. bacterial inoculation dose and infection time, methodological quality and post-mortem evaluation with respect to registration and quantification of pathology and microbiology. Results. In total, 316 publications were included in the systematic review. A substantial lack of study design information (e.g. bacterial identity and infection time) was demonstrated in many of the papers, which hampers reproducibility and continuation of the established work. Furthermore, the methodological study quality was found to be low as definition of infection, randomization, power analysis and blinding were only seldom reported. The use of histology has increased in recent years, but a semi-quantitative scoring of the lesions was often missing, i.e. no objective quantification of outcome. Most of the studies focused on whether the inoculated bacteria were present within the bone tissue post mortem or not. However, very often the bacterial burden was not quantified. In many of the models, different antimicrobial interventions were examined, and the lack of quantitative microbiology makes it difficult to estimate and reproduce the effects objectively. Although, antimicrobial effects were described for most interventions, a lack of sterile outcome was observed in many models. Failure to report a sterile outcome reduces the possibility for obtaining valuable knowledge regarding effective antibiotic doses in-vivo. Based on the present review a standard study template guideline for animal models of bone infections was established. The guideline describes details related to the animal, pathogen, animal + pathogen (infected animal) and post mortem analysis that are of crucial importance for validation of results and reproducibility. Conclusions. Due to a substantial lack of uniformity we miss the opportunity to get maximal knowledge from the preclinical literature. The new guideline will improve reproducibility of future models and translation of findings to the clinical setting. Bone infection organisations/societies and journal editors should encourage compliance with the new guideline. Reference: JBJS, 2019, In press


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_3 | Pages 70 - 70
1 Mar 2021
Mate K Goulding K Košir U Tsimicalis A Turcotte R Freeman C Alcindor T Mayo N
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The patient's subjective experience of disease is an increasing focus in health care delivery. Health-related quality of life (HRQoL) is defined as a “functional effect of a medical condition and its consequent treatment”; it is both self-reported and multi-dimensional. While functional outcome is well researched among the soft tissue sarcoma (STS) population, few studies have focused on HRQoL, which gives a broader understanding of the psychological, somatic, social and physical toll of cancer and its treatment from the patient's viewpoint. The biologic and anatomic heterogeneity of sarcomas are considerable, just as the treatments are diverse, we surmise that the indicators of patient HRQoL differ and are not captured in existing generic HRQoL tools for cancer. The study objectives were to explore the domains of HRQoL and functioning in adult patients diagnosed with extremity STS from the patient's perspective from active care through survivorship through qualitative inquiry, so as to form the basis for the development of a patient-derived, sarcoma-specific, preference based HRQoL tool. Study design is a sequential exploratory mixed methods study of patient experience in localized or metastatic adult extremity STS (2007 and 2017). The study was conducted at a high-volume sarcoma centre. Qualitative descriptive design was grounded in an integrated knowledge translation approach and aimed at identifying HRQoL domains through in-person and electronic focus groups, and individual semi-structured interviews in both English and French (N=28). The interview guide topics were selected based on existing knowledge about PROs and HRQoL life, including (a) impact of diagnosis on employment or acquisition of academic/vocational skills; (b) physical and psychological functioning; (c) symptom burden; (d) treatment preferences; (e) knowledge of and use of existing resources; (f) impact on family time and resources; and (g) overall experience. Data was analyzed using inductive thematic networks approach using the qualitative software N-Vivo 12. Codes were generated by 2 independent qualitative experts capturing key concepts of HRQoL that is impacted by STS. Basic themes were clustered into organizing themes, and merged into global domains. Attention was paid to deviant cases and within-group dynamics during focus group discussion analysis. Discrepancies or inconsistencies in coding were resolved in consensus meetings. Final sample size was determined when data saturation was reached and no new themes emerged. Qualitative reduction of identified items to reach a consensus framework was facilitated by a moderator during multi-disciplinary panel meetings comprised of sarcoma experts, patient partners, allied health staff and other stakeholders. Twenty-nine patients with biopsy-proven localized or metastatic STS of the extremity participated (69% lower extremity STS; mean age 56 years, 25% with local recurrence, 21% metastatic, 18% amputation). Inductive thematic network analysis revealed five function-related domains HRQoL for patients with STS. The functional domains were mapped to the Wilson & Cleary Model and experience domains were mapped to the Picker Institute's Through Patient's Eyes model. This is a critical step toward developing disease specific outcome measures. Patient-centered research is crucial to understanding the impact of surgery, adjuvant therapy and the associated complications for patients with extremity STS, and thereby improving the quality of care provision. This study offers a unique perspective on what domains and sub domains are most impactful on HRQoL and provides the basis for our on-going development of a disease-specific, preference-based HRQoL measure


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 88 - 96
1 Jan 2023
Vogt B Rupp C Gosheger G Eveslage M Laufer A Toporowski G Roedl R Frommer A

Aims

Distraction osteogenesis with intramedullary lengthening devices has undergone rapid development in the past decade with implant enhancement. In this first single-centre matched-pair analysis we focus on the comparison of treatment with the PRECICE and STRYDE intramedullary lengthening devices and aim to clarify any clinical and radiological differences.

Methods

A single-centre 2:1 matched-pair retrospective analysis of 42 patients treated with the STRYDE and 82 patients treated with the PRECICE nail between May 2013 and November 2020 was conducted. Clinical and lengthening parameters were compared while focusing radiological assessment on osseous alterations related to the nail’s telescopic junction and locking bolts at four different stages.


Bone & Joint Open
Vol. 5, Issue 11 | Pages 953 - 961
1 Nov 2024
Mew LE Heaslip V Immins T Ramasamy A Wainwright TW

Aims

The evidence base within trauma and orthopaedics has traditionally favoured quantitative research methodologies. Qualitative research can provide unique insights which illuminate patient experiences and perceptions of care. Qualitative methods reveal the subjective narratives of patients that are not captured by quantitative data, providing a more comprehensive understanding of patient-centred care. The aim of this study is to quantify the level of qualitative research within the orthopaedic literature.

Methods

A bibliometric search of journals’ online archives and multiple databases was undertaken in March 2024, to identify articles using qualitative research methods in the top 12 trauma and orthopaedic journals based on the 2023 impact factor and SCImago rating. The bibliometric search was conducted and reported in accordance with the preliminary guideline for reporting bibliometric reviews of the biomedical literature (BIBLIO).


Bone & Joint Open
Vol. 4, Issue 7 | Pages 539 - 550
21 Jul 2023
Banducci E Al Muderis M Lu W Bested SR

Aims

Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach.

Methods

A comprehensive electronic search and quantitative data analysis from eligible studies were performed. Inclusion criteria were adults with a limb amputation managed with a one- or two-stage osseointegration procedure with follow-up reporting of complications.


Bone & Joint Open
Vol. 4, Issue 3 | Pages 146 - 157
7 Mar 2023
Camilleri-Brennan J James S McDaid C Adamson J Jones K O'Carroll G Akhter Z Eltayeb M Sharma H

Aims

Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set.

Methods

A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy.


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 293 - 302
1 Mar 2024
Vogt B Lueckingsmeier M Gosheger G Laufer A Toporowski G Antfang C Roedl R Frommer A

Aims

As an alternative to external fixators, intramedullary lengthening nails (ILNs) can be employed for distraction osteogenesis. While previous studies have demonstrated that typical complications of external devices, such as soft-tissue tethering, and pin site infection can be avoided with ILNs, there is a lack of studies that exclusively investigated tibial distraction osteogenesis with motorized ILNs inserted via an antegrade approach.

Methods

A total of 58 patients (median age 17 years (interquartile range (IQR) 15 to 21)) treated by unilateral tibial distraction osteogenesis for a median leg length discrepancy of 41 mm (IQR 34 to 53), and nine patients with disproportionate short stature treated by bilateral simultaneous tibial distraction osteogenesis, with magnetically controlled motorized ILNs inserted via an antegrade approach, were retrospectively analyzed. The median follow-up was 37 months (IQR 30 to 51). Outcome measurements were accuracy, precision, reliability, bone healing, complications, and patient-reported outcome assessed by the Limb Deformity-Scoliosis Research Society Score (LD-SRS-30).