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Cite this article: Bone Joint Res 2023;12(9):598–600.


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. 95-B, Issue SUPP_4 | Pages 5 - 5
1 Jan 2013
Ngunjiri A Underwood M Patel S
Full Access

Aims

To develop a decision aid - Decision Support Package (DSP) - that will provide low back pain (LBP) patients, and their treating physiotherapists with information on the treatment options available to the patients

To develop a training package for physiotherapists on how to use the DSP

To encourage and evaluate the informed shared decision making (ISDM) process between patients and physiotherapists during consultation.

Method

We developed a DSP informed by existing research and collaboration with physiotherapists, patients and experts in the field of decision aids and LBP. We did six pieces of exploratory work: literature review; 2009 NICE LBP guidelines review; qualitative screening of transcripts of interviews of LBP patients; focus groups (patients); nominal group (physiotherapists), and Delphi study (experts). We collated these data to develop the DSP. We also developed a training package for physiotherapists.


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. 94-B, Issue SUPP_XXXVI | Pages 34 - 34
1 Aug 2012
White W Harvey J Toms A
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Allogeneic blood transfusion is associated with many complications and significant cost. The RD&E has looked at the use of autologous drains after our study of 100 cases showed an improved post-operative haemoglobin and reduced length of stay. There is a need to identify those patients of increased need for an autologous drain, in order to decrease the frequency of allogeneic transfusion. In 2007 a protocol was drawn up using information from our study of 191 cases which showed an average haemoglobin drop post-operatively of 3.05g/dl and average intra-operative blood loss of 285 ml. This protocol gives the surgeon triggers for autologous drain use; preoperative haemoglobin of <13g/dl, intra-operative blood loss of >400ml, tourniquet use, patient weight <50kg and patients refusing donated blood.

In 2007-08, 65% of a further 275 cases analysed met the triggers for use of an autologous system. The remaining patients received low vacuum drains. Of the 275 patients, only 2 (<1%) of those who did not fulfil the criteria for an autologous drain required allogeneic blood, compared with 43 patients (24%) of those deemed high risk of transfusion, and assigned autologous drains. The protocol was therefore deemed to be successful in identifying those patients who required additional support and expenditure to minimise allogeneic blood transfusion.

Analysis of this data led to recommended changes to the protocol in order to maximise the efficiency of the autologous drain use. In 2010 a further patient cohort studied showed a reduction in allogeneic blood transfusion to <10% of those receiving autologous drains, and an increase to 5% of those with low vacuum drains.

Due to the increased cost of autologous drains (£68) compared with the low vacuum systems (£32), and the cost of allogeneic units at £141, the expenditure per patient was calculated and shown to fall from £92 in 2007 to £78 in the 2010.

In conclusion, this protocol allows the clinician to appropriately target the use of the more expensive autologous drains to those of increased risk of transfusion. This protocol helps to minimise unnecessary allogeneic blood transfusion risks, and this has been shown to be more cost effective.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIX | Pages 97 - 97
1 Jul 2012
White WJ Harvey J Toms AD
Full Access

Allogeneic blood transfusion is associated with complications and significant cost. The RD&E has looked at the use of autologous drains to decrease the frequency of allogeneic transfusion after our study of 100 cases showed an improved post-operative haemoglobin and reduced length of stay. In 2007 a protocol to identify those patients of increased need for an autologous drain was made using a study of 191 cases showed an average haemoglobin drop post-operatively of 3.05g/dl and average intra-operative blood loss of 285 ml. This protocol gave triggers for autologous drain use; preoperative haemoglobin of <13g/dl, intra-operative blood loss >400ml, tourniquet use, patient weight <50kg and patients refusing donated blood.

In 2007-08, 65% of a further 275 cases analysed met the triggers for use of an autologous system. The remaining patients received low vacuum drains. Of the 275 patients, only 2 (<1%) of those who did not fulfil the criteria for an autologous drain required allogeneic blood, compared with 43 patients (24%) of those deemed high risk of transfusion, and assigned autologous drains. The protocol was successful in identifying those patients who required additional support and expenditure to minimise allogeneic blood transfusion.

Analysis of this data led to recommended changes to the protocol in order to maximise the efficiency of the autologous drain use.

Due to the increased cost of autologous drains (£68) compared with the low vacuum systems (£32), and the cost of allogeneic units at £141, the expenditure per patient was calculated and shown to fall from £92 in 2007 to £78 in a further patient cohort in 2010.

In conclusion, this protocol allows the clinician to appropriately target the use of the more expensive autologous drains to those of increased risk of transfusion. This helps to minimise unnecessary allogeneic transfusion, and this has been shown to be cost effective.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 39 - 39
17 Nov 2023
FARHAN-ALANIE M Gallacher D Kozdryk J Craig P Griffin J Mason J Wall P Wilkinson M Metcalfe A Foguet P
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Abstract. Introduction. Component mal-positioning in total hip replacement (THR) and total knee replacement (TKR) can increase the risk of revision for various reasons. Compared to conventional surgery, relatively improved accuracy of implant positioning can be achieved using computer assisted technologies including navigation, patient-specific jigs, and robotic systems. However, it is not known whether application of these technologies has improved prosthesis survival in the real-world. This study aimed to compare risk of revision for all-causes following primary THR and TKR, and revision for dislocation following primary THR performed using computer assisted technologies compared to conventional technique. Methods. We performed an observational study using National Joint Registry data. All adult patients undergoing primary THR and TKR for osteoarthritis between 01/04/2003 to 31/12/2020 were eligible. Patients who received metal-on-metal bearing THR were excluded. We generated propensity score weights, using Sturmer weight trimming, based on: age, gender, ASA grade, side, operation funding, year of surgery, approach, and fixation. Specific additional variables included position and bearing for THR and patellar resurfacing for TKR. For THR, effective sample sizes and duration of follow up for conventional versus computer-guided and robotic-assisted analyses were 9,379 and 10,600 procedures, and approximately 18 and 4 years, respectively. For TKR, effective sample sizes and durations of follow up for conventional versus computer-guided, patient-specific jigs, and robotic-assisted groups were 92,579 procedures over 18 years, 11,665 procedures over 8 years, and 644 procedures over 3 years, respectively. Outcomes were assessed using Kaplan-Meier analysis and expressed using hazard ratios (HR) and 95% confidence intervals (CI). Results. For THR, analysis comparing computer-guided versus conventional technique demonstrated HR of 0.771 (95%CI 0.573–1.036) p=0.085, and 0.594 (95%CI 0.297–1.190) p=0.142, for revision for all-causes and dislocation, respectively. When comparing robotic-assisted versus conventional technique, HR for revision for all-causes was 0.480 (95%CI 0.067 –3.452) p=0.466. For TKR, compared to conventional surgery, HR for all-cause revision for procedures performed using computer guidance and patient-specific jigs were 0.967 (95% CI 0.888–1.052) p=0.430, and 0.937 (95% CI 0.708–1.241) p=0.65, respectively. HR for analysis comparing robotic-assisted versus conventional technique was 2.0940 (0.2423, 18.0995) p = 0.50. Conclusions. This is the largest study investigating this topic utilising propensity score analysis methods. We did not find a statistically significant difference in revision for all-causes and dislocation although these analyses are underpowered to detect smaller differences in effect size between groups. Additional comparison for revision for dislocation between robotic-assisted versus conventionally performed THR was not performed as this is a subset of revision for all-causes and wide confidence intervals were already observed for that analysis. It is also important to mention this NJR analysis study is of an observational study design which has inherent limitations. Nonetheless, this is the most feasible study design to answer this research question requiring use of a large data set due to revision being a rare outcome. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project


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. Discussion. The primary outcome is ‘treatment failure’ (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or ‘treatment success’ (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry. Cite this article: Bone Jt Open 2023;4(11):873–880


Bone & Joint Open
Vol. 4, Issue 9 | Pages 659 - 667
1 Sep 2023
Nasser AAHH Osman K Chauhan GS Prakash R Handford C Nandra RS Mahmood A

Aims. Periprosthetic fractures (PPFs) following hip arthroplasty are complex injuries. This study evaluates patient demographic characteristics, management, outcomes, and risk factors associated with PPF subtypes over a decade. Methods. Using a multicentre collaborative study design, independent of registry data, we identified adults from 29 centres with PPFs around the hip between January 2010 and December 2019. Radiographs were assessed for the Unified Classification System (UCS) grade. Patient and injury characteristics, management, and outcomes were compared between UCS grades. A multinomial logistic regression was performed to estimate relative risk ratios (RRR) of variables on UCS grade


Bone & Joint Open
Vol. 5, Issue 4 | Pages 367 - 373
26 Apr 2024
Reinhard J Lang S Walter N Schindler M Bärtl S Szymski D Alt V Rupp M

Aims. Periprosthetic joint infection (PJI) demonstrates the most feared complication after total joint replacement (TJR). The current work analyzes the demographic, comorbidity, and complication profiles of all patients who had in-hospital treatment due to PJI. Furthermore, it aims to evaluate the in-hospital mortality of patients with PJI and analyze possible risk factors in terms of secondary diagnosis, diagnostic procedures, and complications. Methods. In a retrospective, cross-sectional study design, we gathered all patients with PJI (International Classification of Diseases (ICD)-10 code: T84.5) and resulting in-hospital treatment in Germany between 1 January 2019 and 31 December 2022. Data were provided by the Institute for the Hospital Remuneration System in Germany. Demographic data, in-hospital deaths, need for intensive care therapy, secondary diagnosis, complications, and use of diagnostic instruments were assessed. Odds ratios (ORs) with 95% confidence intervals (CIs) for in-hospital mortality were calculated. Results. A total of 52,286 patients were included, of whom 1,804 (3.5%) died. Hypertension, diabetes mellitus, and obesity, the most frequent comorbidities, were not associated with higher in-hospital mortality. Cardiac diseases as atrial fibrillation, cardiac pacemaker, or three-vessel coronary heart disease showed the highest risk for in-hospital mortality. Postoperative anaemia occurred in two-thirds of patients and showed an increased in-hospital mortality (OR 1.72; p < 0.001). Severe complications, such as organ failure, systemic inflammatory response syndrome (SIRS), or septic shock syndrome showed by far the highest association with in-hospital mortality (OR 39.20; 95% CI 33.07 to 46.46; p < 0.001). Conclusion. These findings highlight the menace coming from PJI. It can culminate in multi-organ failure, SIRS, or septic shock syndrome, along with very high rates of in-hospital mortality, thereby highlighting the vulnerability of these patients. Particular attention should be paid to patients with cardiac comorbidities such as atrial fibrillation or three-vessel coronary heart disease. Risk factors should be optimized preoperatively, anticoagulant therapy stopped and restarted on time, and sufficient patient blood management should be emphasized. Cite this article: Bone Jt Open 2024;5(4):367–373


Bone & Joint Open
Vol. 4, Issue 5 | Pages 338 - 356
10 May 2023
Belt M Robben B Smolders JMH Schreurs BW Hannink G Smulders K

Aims. To map literature on prognostic factors related to outcomes of revision total knee arthroplasty (rTKA), to identify extensively studied factors and to guide future research into what domains need further exploration. Methods. We performed a systematic literature search in MEDLINE, Embase, and Web of Science. The search string included multiple synonyms of the following keywords: "revision TKA", "outcome" and "prognostic factor". We searched for studies assessing the association between at least one prognostic factor and at least one outcome measure after rTKA surgery. Data on sample size, study design, prognostic factors, outcomes, and the direction of the association was extracted and included in an evidence map. Results. After screening of 5,660 articles, we included 166 studies reporting prognostic factors for outcomes after rTKA, with a median sample size of 319 patients (30 to 303,867). Overall, 50% of the studies reported prospectively collected data, and 61% of the studies were performed in a single centre. In some studies, multiple associations were reported; 180 different prognostic factors were reported in these studies. The three most frequently studied prognostic factors were reason for revision (213 times), sex (125 times), and BMI (117 times). Studies focusing on functional scores and patient-reported outcome measures as prognostic factor for the outcome after surgery were limited (n = 42). The studies reported 154 different outcomes. The most commonly reported outcomes after rTKA were: re-revision (155 times), readmission (88 times), and reinfection (85 times). Only five studies included costs as outcome. Conclusion. Outcomes and prognostic factors that are routinely registered as part of clinical practice (e.g. BMI, sex, complications) or in (inter)national registries are studied frequently. Studies on prognostic factors, such as functional and sociodemographic status, and outcomes as healthcare costs, cognitive and mental function, and psychosocial impact are scarce, while they have been shown to be important for patients with osteoarthritis. Cite this article: Bone Jt Open 2023;4(5):338–356


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 3 - 3
7 Aug 2023
Fennelly J Santini A Papalexandris S Pope J Yorke J Davidson J
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Abstract. Background. Oxidized zirconium (OxZr) has been introduced as an alternative bearing for femoral components in Total Knee Arthroplasty (TKA). It has a ceramic-like zirconium oxide outer layer with a low coefficient of friction. Early studies have found OxZr TKA to have a low incidence of early failure in young high demand patients. Currently no study has reported on the outcome of these implants beyond ten years. Objectives. The purpose of our study was to present an in-depth 15-year survival analysis of cemented Profix II OxZr TKA. Study Design & Methods. Data was collected prospectively and survival analysis undertaken with multiple strict end points. Complication rates were recorded and patient reported outcomes were measured. Results. 617 Profix II OxZr TKAs were performed over four years. Forty-nine patients underwent reoperation. Aseptic tibial loosening was the most common cause of failure (32.7%) on average occurring 2.8 years post primary procedure. There was one recorded failure due to loosening of the zirconium femoral component. Revision rate at 15-years was 6.38%. Cumulative survivorship was 91.52% with failure considered to be reoperation for any reason. WOMAC score improved in 86% of patients by year 1. The average score improved by 21.2 points and met the standard for minimum clinically important difference. Conclusions. This study presents the first 15-year survival analysis of cemented Profix II OxZr TKA. Our data supports current literature on the long-term survivorship of oxidised zirconium total knee replacements


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 68 - 68
14 Nov 2024
Nøhr LM Simony A Abrahamsen C
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Introduction. Shared decision making (SDM) was introduced in hospital Lillebelt in 2019 and research reports that patients are more satisfied with their treatment, if they play an active role in choosing treatment. A Decision-Helper was constructed and introduced in the treatment for Colles fractures. This study aimed to understand how patients experience shared decision-making (SDM) for an acute illness, and how it affects them when making decisions about the treatment of their distal radius fracture. Method. An exploratory, qualitative study design was performed to understand the patient's experience, during the choice of treatment with SDM. 12 were recruited when they came to their first follow-up 5 days after the injury, in the outpatient clinic. 10 were interviewed; 3 face to face and 7 by telephone. All women aged 57-87 years and all had a displaced Colles fracture, which had been reduced in the Emergency Room. Result. Analyzing the interviews three themes emerged: 1) Acute situation. Patients was positive towards SDM, but found it demanding to participate in. Patients was still in crisis, 5 days after suffering from a fracture. Patients were unable to remember the information given in the ER, regarding the use of the Decision helper. Few had prepared themselves for the consult in the outpatient clinic. 2) Influence on treatment choice. It was unclear to the majority of patients, that cast or surgery, resulted in similar clinical outcomes. 3) The treatment decision was based on personal factors, more than the information received during the consult. Conclusion. Patients wants to be included in the treatment decision. It is important to highlight that booth treatments are equal in clinical outcome, before introducing the Decision-Helper. The doctor´s demeanor is of great importance to the patient's experience. Introducing SDM in the clinical setting requires training and repeated observations, to succeed


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 129 - 129
11 Apr 2023
Vermeir R Wittouck L Peiffer M Huysse W Martinelli N Stufkens S Audenaert E Burssens A
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The incisura fibularis (IF) provides intrinsic stability to the ankle joint complex by interlocking the distal tibia and fibula. Despite a high frequency of ligamentous ankle injuries, scant attention has been given to the morphology of the IF morphology incisura fibularis in the onset and development of these lesions. Therefore, we systematically reviewed the relation between ligamentous ankle disorders and the morphometrics of the IF. A systematic literature search was conducted on following databases: PubMed, Embase and Web of Science. Search terms consisted of ‘ankle trauma’, ‘ankle injury’, ‘ankle sprain’, ‘ankle fracture’, ‘tibiofibular’, ‘fibular notch’, ‘fibular incisura’, ‘incisura fibularis’, ‘morphometric analysis’, ‘ankle syndesmosis’, ‘syndesmotic stability’. The evaluation instrument developed by Hawker et al. was used to assess the quality of the selected studies. This protocol was performed according to the PRISMA guidelines and is registered on PROSPERO (CRD42021282862). Nineteen studies were included and consisted of prospective cohort (n=1), retrospective comparative (n=10), and observational (n=8) study design. Comparative studies have found certain morphological characteristics in patients with ankle instability. Several studies (n=5) have correlated a shallow IF depth with a higher incidence of ankle injury. A significant difference has also been found concerning the incisura height and angle (n=3): a shorter incisura and more obtuse angle have been noted in patients with ankle sprains. The mean Hawker score was 28 out of 36 (range=24-31). A shallower IF is associated with ligamentous ankle lesions and might be due to a lower osseous resistance against tibiofibular displacement. However, these results should be interpreted in light of moderate methodological quality and should always be correlated with clinical findings. Further prospective studies are needed to further assess the relation between the incisura morphometrics and ligamentous disorders of the ankle joint. Keywords: ankle instability, ankle injury, incisura fibularis, fibular notch, tibiofibular morphometrics, ankle syndesmosis


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. 106-B, Issue SUPP_9 | Pages 1 - 1
16 May 2024
Brandao B Aljawadi A Fox A Pillai A
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Objectives. Cartiva synthetic cartilage implant (SCI) is licenced for use in management of symptomatic hallux rigidus in several countries including the UK. As for now, there are no independent comparative series for treatment of hallux rigidus utilising polyvinyl alcohol implants. Study design and methods. Patients at a single centre with symptomatic hallux rigidus who underwent Cartiva SCI implant procedure were identified. First metatarsophalangeal joint arthritis was radiographically graded according to the Hattrup and Johnson (HJ) classification. Pre-operative and post-operative patient-reported outcomes were evaluated using the Foot and Ankle Ability Measure (FAAM) activities of daily living subscale and the Manchester-Oxford Foot Questionnaire (MOXFQ). Results. 66 patients (19M, 47F) (43R and 23L) were followed up for an average of 14 months (min=2, max=36). 17 patients suffered from HJ2/moderate arthritis and 49 patients with grade HJ3/severe arthritis. Post-operative mean FAAM scores showed statistically significant improvement (p< 0.0001). Patients reported a 40% increase in functionality during activities of daily living. All 3 MOXFQ Domain scores improved significantly (p< 0.02). The Index score improved by 28 points (p< 0.0001). There was no correlation between length of follow up or age and PROMs (r=0.129). No statistical difference was demonstrated between sexes. However clinically, males and older patients exhibit better outcomes. There was a 89.4% patient satisfaction with the use of Cartiva. Conclusions. Our study shows excellent results with statistically significant improvements in functional outcomes, and promising short-term follow-up with low early revision rates. Pain in particular was significantly reduced. One third of patients developed post-operative stiffness requiring a manipulation under anaesthesia. Patient selection is key. Additional imaging may be required to assess sesamoid osteoarthritis. At 3 years the implant has demonstrated to be safe and efficacious in the management of hallux rigidus. Durability and survivability of the implant will continue to be studied in this cohort


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_12 | Pages 3 - 3
10 Jun 2024
Alsousou J Keene D Harrison P O'Connor H Wagland S Dutton S Hulley P Lamb S Willett K
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Background. The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture. Study design. Randomised multi-centre two-arm parallel-group, participant- and assessor-blinded, superiority trial. Methods. Adults with acute ATR managed non-surgically were recruited in 19 UK hospitals from 2015 to 2019. Exclusions were insertion or musculotendinous injuries, leg injury or deformity, diabetes, haematological disorder, corticosteroids and anticoagulation therapy. Participants were randomised via an online system 1:1 to PRP or placebo. Primary outcome was Achilles Tendon Rupture Score (ATRS) at two-years. Secondary outcomes were pain, Patient-Specific Functional Scale (PSFS), SF-12 and re-rupture. Assessors were blinded. Intention-to-treat and Compliance Average Causal effects (CACE) analyses were carried out. Consistency of effects across subgroups age, BMI, smoking and gender were assessed using Forest plots. Pearson's correlation was used to explore ATRS correlation with blood and growth factors. Results. 216/230 (94%) participants completed the 6-months follow-up were contacted. 182/216 (84%) completed the two-year follow-up. Participants were aged mean 46 (SD 13.0), 57 female/159 male. 96% received the allocated intervention. Two-years ATRS scores were 82.2 (SD 18.3) in the PRP group (n=85) and 83.8 (SD 16.0) in the placebo group (n=92). There was no evidence of a difference in the two-years ATRS (adjusted-mean difference −0.752 95%CI −5.523 to 4.020, p=0.757), or in any secondary outcome, and no re-rupture between at two-years. Neither PRP cellular or growth factors correlated with the two-year ATRS. Conclusion. PRP did not improve patient-reported function or quality of life two-years after acute Achilles tendon rupture, compared with placebo, indicating that PRP offers no patient benefit in the longer term


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_2 | Pages 7 - 7
2 Jan 2024
Raes L Peiffer M Kvarda P Leenders T Audenaert EA Burssens A
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A medializing calcaneal osteotomy (MCO) is one of the key inframalleolar osteotomies to correct progressive collapsing foot deformity (PCFD). While many studies were able to determine the hind- and midfoot alignment after PCFD correction, the subtalar joint remained obscured by superposition on plain radiography. Therefore, we aimed to perform a 3D measurement assessment of the hind- and subtalar joint alignment pre- compared to post-operatively using weightbearing CT (WBCT) imaging. Fifteen patients with a mean age of 44,3 years (range 17-65yrs) were retrospectively analyzed in a pre-post study design. Inclusion criteria consisted of PCFD deformity correct by MCO and imaged by WBCT. Exclusion criteria were patients who had concomitant midfoot fusions or hindfoot coalitions. Image data were used to generate 3D models and compute the hindfoot - and talocalcaneal angle as well as distance maps. Pre-operative radiographic parameters of the hindfoot and subtalar joint alignment improved significantly relative to the post-operative position (HA, MA. Sa. , and MA. Co. ). The post-operative talus showed significant inversion, abduction, and dorsiflexion of the talus (2.79° ±1.72, 1.32° ±1.98, 2.11°±1.47) compared to the pre-operative position. The talus shifted significantly different from 0 in the posterior and superior direction (0.62mm ±0.52 and 0.35mm ±0.32). The distance between the talus and calcaneum at the sinus tarsi increased significantly (0.64mm ±0.44). This study found pre-dominantly changes in the sagittal, axial and coronal plane alignment of the subtalar joint, which corresponded to a decompression of the sinus tarsi. These findings demonstrate the amount of alternation in the subtalar joint alignment that can be expected after MCO. However, further studies are needed to determine at what stage a calcaneal lengthening osteotomy or corrective arthrodesis is indicated to obtain a higher degree of subtalar joint alignment correction


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