Abstract. Objectives. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Results. Nine randomised controlled trials (RCTs) and 19 observational studies fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. This study reports a significantly decreased relative risk of complications when femoral diaphyseal fractures in children aged 4 to 12 are managed with plates. The overall quality of evidence is low, highlighting the need for a prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior

Introduction and Objective. The most common paediatric orthopaedic injury requiring hospital admission is a femoral fracture. There is debate regarding the optimal surgical technique for fixing femoral diaphyseal fractures in children aged 4 to 12 years. The National Institute for Health and Care Excellence (NICE) and the American Academy of Orthopaedic Surgeons (AAOS) have issued relevant guidelines, however, there is limited evidence to support these. The aim of this study was to conduct a systematic review and meta-analysis to compare the complication rate following flexible intramedullary nailing (FIN), plate fixation and external fixation (EF) for traumatic femoral diaphyseal fractures in children aged 4 to 12. Materials and Methods. We searched MEDLINE, EMBASE and CENTRAL databases for interventional and observational studies. Two independent reviewers screened, assessed quality and extracted data from the identified studies. The primary outcome was the risk of any complication. Secondary outcomes assessed the risk of pre-specified individual complications. Results. Nine randomised controlled trials (RCTs) and 19 observational studies (six prospective and 13 retrospective) fulfilled the eligibility criteria. Within the RCTs, five analysed FIN (n=161), two analysed plates (n=51) and five analysed EF (n=168). Within the observational studies, 13 analysed FIN (n=610), seven analysed plates (n=214) and six analysed EF (n=153). The overall risk of complications was lower following plate fixation when compared to FIN fixation (RR 0.45, 95% CI 0.28 to 0.73, p=0.001) in the observational studies. The overall risk of complications was higher following EF when compared to FIN fixation in both RCTs (RR 1.94, 95% CI 1.25 to 3.01, p=0.003) and observational studies (RR 1.97, 95% CI 1.50 to 2.58, p<0.001). The overall risk of complications was higher following EF when compared to plate fixation in both RCTs (RR 7.42, 95% CI 1.84 to 29.98, p=0.005) and observational studies (RR 4.39, 95% CI 2.64 to 7.30, p<0.001). Conclusions. Although NICE and the AAOS recommend FIN for femoral diaphyseal fractures in children aged 4 to 12, this study reports a significantly decreased relative risk of complications when these injuries are managed with plates. Our findings provide valuable information to healthcare professionals who are involved in discussing the risk and benefits of different management options with patients and their families. The overall quality of evidence is low, highlighting the need for a rigorous prospective multicentre randomised trial at low risk of bias due to randomisation and outcome measurement to identify if any fixation technique is superior

Introduction and Objective. Postoperative management regimes vary following open reduction and internal fixation of unstable ankle fractures. There is an evolving understanding that poorer outcomes could be associated with non-weight bearing protocols and immobilisation. Traditional non-weight bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The aim of this systematic review and meta-analysis is to compare the complication rate and functional outcomes of early weight-bearing (EWB) versus late weight-bearing (LWB) following open reduction and internal fixation of ankle fractures. Materials and Methods. We performed a systematic review with a meta-analysis of controlled trials and comparative cohort studies. MEDLINE (via PubMed), Embase and the Cochrane Library electronic databases were searched inclusive of all date up to the search time. We included all studies that investigated the effect of weight-bearing following adults ankle fracture fixation by any means. All ankle fracture types, including isolated lateral malleolus fractures, isolated medial malleolus fractures, bi-malleolar fractures, tri-malleolar fractures and Syndesmosis injuries, were included. All weight-bearing protocols were considered in this review, i.e. immediate weight-bearing (IMW) within 24 hours of surgery, early weight-bearing (EWB) within three weeks of surgery, non-weight-bearing for 4 to 6 weeks from the surgery date (or late weight-bearing LWB). Studies that investigated mobilisation but not weight-bearing, non-English language publications and tibial Plafond fractures were excluded from this systematic review. We assessed the risk of bias using ROB 2 tools for randomised controlled trials and ROBINS-1 for cohort studies. Data extraction was performed using Covidence online software and meta-analysis by using RevMan 5.3. Results. After full-text review, fourteen studies (871 patients with a mean age ranged from 35 to 57 years) were deemed eligible for this systematic review; ten randomised controlled trials and four comparative cohort studies. Most of the included studies were rated as having some concern with regard to the risk of bias. There is no important difference in the infection rate between protected EWB and LWB groups (696 patients in 12 studies). The risk ratio (RR) is 1.30, [95% CI 0.74 to 2.30], I. 2. = 0%, P = 0.36). Other complications were rare. The Olerud-Molander Ankle Score (OMAS) was the widely used patient-reported outcome measure after ankle fracture fixation among the studies. The result of the six weeks OMAS analysis (three RCTs) was markedly in favour of the early weight-bearing group (MD = 10.08 [95% CI 5.13 to 15.02], I. 2. = 0%P = <0.0001). Conclusions. The risk of postoperative complications is an essential factor when considering EWB. We found that the overall incidence of surgical site infection was 6%. When comparing the two groups, the incidence was 5.2% and 6.8% for the LWB and EWB groups. This difference is not clinically important. On the other hand, significantly better early functional outcome scores were detected in the EWB group. These results are not without limitations. Protected early weight-bearing following open reduction and internal fixation of ankle fractures is potentially safe and improve short-term functional outcome. Further good-quality randomised controlled trials would be needed before we could draw a more precise conclusion

Around 1% of total hip replacements are follow by prosthetic joint infection (PJI). There is uncertainty about best treatment method for PJI, and the most recent high quality systematic reviews in unselected patients indicates that re-infection rates following one-stage and two-stage revision arthroplasty are relatively similar. In the absence of evidence randomised controlled trials will help to identify the most clinically and cost-effective treatment for PJI. Before such trials are conducted, there is a need to establish reasons for current practice and to identify whether trials are feasible. This study aimed to deliver research that would inform trial design. Specifically, we aimed to characterise consultant orthopaedic surgeons' decisions about performing either one-stage or two-stage exchange arthroplasty for patients with PJI after hip replacement and to identify whether a randomised trial comparing one-stage with two-stage revision would be possible. Semi-structured interviews were conducted with 12 consultant surgeons from 5 high-volume National Health Service (NHS) orthopaedic departments in the UK. Surgeons were sampled on the basis that they perform revision surgery for PJI after hip arthroplasty and final sample size was justified on the basis of thematic saturation. Surgeons were interviewed face-to-face (n=2) or via telephone (n=10). The interview study took place before design of a multicentre prospective randomised controlled trial comparing patient and clinical outcomes after one-stage or two-stage revision arthroplasty. Data were audio-recorded, transcribed, anonymised and analysed using a thematic approach, with 25% of transcripts independently double-coded. Results: There is no standard surgical response to the treatment of PJI and surgeons manage a complex balance of factors when choosing a surgical strategy. These include multiple patient-related factors, their own knowledge and expertise, available infrastructure and the infecting organism. Surgeons questioned whether evidence supports the emergence of two-stage revision as a method. They described the use of loosely cemented articulating spacers as a way of managing uncertainty about best treatment method. All surgeons were supportive of a randomised trial to compare one-stage and two-stage revision surgery for PJI after hip replacement. Surgeons reported that they would put patients forward for randomisation when there was uncertainty about best treatment. Surgeons highlighted the need for evidence to support their choice of revision. Some surgeons now use revision methods that can better address both clinical outcomes and patients' quality of life, such as loosely cemented articulating spacers. Surgeons thought that a randomised controlled trial comparing one-stage and two-stage exchange joint replacement is needed and that randomisation would be feasible. The next stage of the work was to design a multi-centre randomised controlled trial, this has been achieved and the trial is now ongoing in the UK

Abstract. BACKGROUND. The effectiveness of anti-embolic graduated compression stockings (GCSs) has recently been questioned. The aim of this study is to systematically review all the relevant randomised controlled trials published to date. PATIENTS AND METHODS. We systematically reviewed all the randomised controlled trials comparing anti-embolism stockings with no stockings. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and CINAHL, Cochrane Musculoskeletal Injuries Group specialized register and the reference lists of articles as well as hand search results. Trials were independently assessed and data for the main outcome measures; deep vein thrombosis (DVT), pulmonary embolism and skin ulceration, were extracted by two reviewers. RESULTS. A total of 26 relevant RCTs involving 8279 participants were systematically reviewed. Theoccurrence of deep vein thrombosis was 306/4159(7.3%) with the stocking to 492/4120(11.9%) without the stockings (RR 0.49, 95% CI 0.39–0.62). The occurrence of pulmonary embolism was also reduced from 1.2% go 0.7% (95% 0.33–0.92). This initial finding was unsound due to the potential underreporting of negative studies and the subsequent changes to clinical practice. For the three large contemporary studies involving 5171 participants, these failed to show any statistically significant reduction in thrombosis, with DVT confirmed in 158(6.1%) participants in those allocated to stocking, as opposed to 171(6.6%) in the control group. CONCLUSION. The current recommendations regarding the use of GCSs need to be reconsidered, as their effectiveness at reducing the occurrence of post-operative DVT is minimal at best, based on the current evidence and clinical practices

Introduction and Objective. The effectiveness of anti-embolic graduated compression stockings (GCSs) has recently been questioned. The aim of this study is to systematically review all the relevant randomised controlled trials published to date. Materials and Methods. We systematically reviewed all the randomised controlled trials comparing anti-embolism stockings with no stockings. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and CINAHL, Cochrane Musculoskeletal Injuries Group specialized register and the reference lists of articles as well as hand search results. Trials were independently assessed and data for the main outcome measures; deep vein thrombosis (DVT), pulmonary embolism and skin ulceration, were extracted by two reviewers. Results. A total of 26 relevant RCTs involving 8279 participants were systematically reviewed. The occurrence of deep vein thrombosis was 306/4159 (7.3%) with the stocking to 492/4120 (11.9%) without the stockings (RR 0.49, 95% CI 0.39–0.62). The occurrence of pulmonary embolism was also reduced from 1.2% to 0.7% (95% 0.33–0.92). This initial finding was unsound due to the potential underreporting of negative studies and the subsequent changes to clinical practice. For the three large contemporary studies involving 5171 participants, these failed to show any statistically significant reduction in thrombosis, with DVT confirmed in 158 (6.1%) participants in those allocated to stocking, as opposed to 171 (6.6%) in the control group. Conclusions. The current recommendations regarding the use of thrombo-embolic stockings need to be reconsidered, as their effectiveness at reducing the occurrence of post-operative deep vein thrombosis is minimal at best, based on the current evidence and clinical practices

There remains much debate regarding the optimal method for surgical management of patients with long head of biceps pathology. The aim of this study was to compare the outcomes of tenotomy versus tenodesis. This systematic review and meta-analysis was registered on PROSPERO (ref: CRD42020198658). Electronic databases searched included EMBASE, Medline, PsycINFO, and Cochrane Library. Randomized controlled trials (RCTs) comparing tenotomy versus tenodesis were included. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and the Jadad score. The primary outcome included patient reported functional outcome measures pooled using standardized mean difference (SMD) and a random effects model. Secondary outcome measures included pain (visual analogue scale VAS), rate of Popeye deformity, and operative time. 860 patients from 11 RCTs (426 tenotomy vs 434 tenodesis) were included in the meta-analysis. Pooled analysis of all PROMs data demonstrated comparable outcomes between tenotomy vs tenodesis (SMD 0.14, 95% CI −0.04 to 0.32; p=0.13). Sensitivity analysis comparing RCTs involving patients with and without an intact rotator cuff did not change the primary outcome. There was no significant difference for pain (VAS). Tenodesis resulted in a lower rate of Popeye deformity (OR 0.29, 95% CI 0.19 to 0.45, p < 0.00001). Tenotomy demonstrated a shorter operative time (MD 15.21, 95% CI 1.06 to 29.36, p < 0.00001). Aside from a lower rate of cosmetic deformity, tenodesis yielded no measurable significant benefit to tenotomy for addressing pathology in the long head of biceps. A large multi-centre clinical effectiveness randomised controlled trial is needed to provide clarity in this area

Total knee replacement (TKR) design aims to restore normal kinematics with emphasis on flexion range. The survivorship of a TKR is dependent on the kinematics in six-degrees-of-freedom (6-DoF). Stepping up, such as stair ascent is a kinematically demanding activity after TKR. The debate about design choice has not yet been informed by 6-DoF in vivo kinematics. This prospective randomised controlled trial (RCT) compared kneeling kinematics in three TKR designs. 68 participants were randomised to receive either cruciate retaining (CR-FB), rotating platform (CR-RP) or posterior stabilised (PS-FB) prostheses. Image quality was sufficient for 49 of these patients to be included in the final analysis following a minimum 1-year follow-up. Patients completed a step-up task while being imaged using single-plane fluoroscopy. Femoral and tibial computer-aided design (CAD) models for each of the TKR designs were registered to the fluoroscopic images using bespoke software OrthoVis to generate six-degree-of-freedom kinematics. Differences in kinematics between designs were compared as a function of flexion. There were no differences in terminal extension between the groups. The CR-FB was further posterior and the CR-RP was more externally rotated at terminal extension compared to the other designs. Furthermore, the CR-FB designs was more posteriorly positioned at each flexion angle compared to both other designs. Additionally, the CR-RP design had more external femoral rotation throughout flexion when compared with both fixed bearing designs. However, there were no differences in total rotation for either step-up or down. Visually, it appears there was substantial variability between participants in each group, indicating unique patient-specific movement patterns. While use of a specific implant design does influence some kinematic parameters, the overall patterns are similar. Furthermore, there is high variability indicating patient-specific kinematic patterns. At a group level, none of these designs appear to provide markedly different step-up kinematic patterns. This is important for patient expectations following surgery. Future work should aim to better understand the unique patient variability

Prosthetic joint infection (PJI) is an uncommon but serious complication of hip replacement. Over 1,000 operations are performed annually in the United Kingdom for PJI following hip replacement, using either one- or two-stage revision arthroplasty. It is unclear which is preferred by patients and which has the best long-term outcome. This qualitative study aims to describe patient experiences of treatment and recovery following one- and two-stage revision arthroplasty for PJI within the context of a pragmatic randomised controlled trial comparing these two approaches. Semi-structured interviews were conducted with 32 patients undergoing one- or two-stage revision treatment for PJI as part of a UK multi-centre randomised controlled trial. Patients were recruited from 12 participating National Health Service (NHS) Orthopaedic Departments and were interviewed 2–4 months after their first revision surgery and again approximately 18 months later. Final sample size was justified on the basis of thematic saturation. All patients consented to the interview being audio-recorded, transcribed, anonymised and analysed using an inductive thematic approach. Ethical approval was provided by NRES Committee South-West Frenchay, 14/SW/116. Patients in both the one- and two-stage treatment groups described prolonged hospital stays, with burdensome antibiotics and brief physiotherapy treatment. However, following discharge home and during recovery, participants undergoing two-stage revision with an ‘empty hip' or with a spacer reported being physically restricted in almost every aspect of their daily life, resulting in inactivity and confinement to home. Mobility aids were not sufficiently available through the health service for these patients. A key difference is that those with a spacer reported more pain than those without. Approximately one year following their second-stage revision, participants described being more independent and active, but two directly attributed muscle weakness to the lengthy period without a hip and described resulting falls or dislocations that had complicated their recovery. In contrast, those undergoing one-stage revision and CUMARS appeared to be more alike, reporting better mobility, functionality and independence, although still limited. Participants in these groups also reported minimal or no pain following their revision. A key difference between CUMARS and one-stage revision was the uncertainty of whether a second operation was necessary, which participants described as “hanging over them”, while those in the two-stage empty hip or spacer group described a more positive anticipation of a second definitive operation as it marked an end to what was described as a detachment from life. Our findings highlight the differences between patient experiences of recovery following revision arthroplasty, and how this is influenced by the surgical approach and presence or lack of spacers. An understanding of lived experiences following one- and two-stage surgical interventions will complement knowledge about the clinical effectiveness of these different types of revision surgery

Plantar fasciitis (PF) is one of the widespread conditions causing hindfoot pain. The most common presenting symptoms are functional limitation and pain (first step and activity) on plantar surface of the foot. The non-operative treatments provide complete resolution of pain in 90% of patients, but functional limitation still remains as a risk factor for recurrency of PF. Although the number of non-operative treatment options showing efficacy on pain and functional limitation are excessive, the evidences are limited for functional limitation. Additionally, Mulligan mobilization with movement (MMWM) in Chronic Plantar Fasciitis has been poorly studied in the literature. According to these findings, the study was aimed to determine effectiveness of Mulligan mobilization with movement on Chronic Plantar Fasciitis. A total of 25 patients (40 feet) with chronic PF were included in the study. The patients were randomly divided into Mulligan concept rehabilitation group (PF-M, n=20 feet) and Home Rehabilitation group (PF-H, n=20 feet). (MMWM), Foot and ankle exercises program were applied to PF-M, twice a week totally 8 week (16 sessions) and foot- ankle exercises as a home program were given for PF-H, 8 weeks. The range of motion (ROM) for dorsiflexion and plantar flexion was measured by using a manual goniometer. Pain, disability and activity restriction were assessed by Foot Function Index (FFI) . The first step morning pain was evaluated by Visual Analogue Scale (VAS) and Kinesiophobia was also reported by using Tampa Scale (TSK). Patients were evaluated at baseline and 8 weeks. FFI, VAS, TSK, ROM values improved in all groups (intragroup variability) at 8th week (P < .05). The other result indicated that ROM values for DF and PF and TSK scores in PF-M had more significant improvement than PF-H (p<.05). To the best of our knowledge this is the first randomised controlled trial for investigating Mulligan Concept efficiancy on chronic PF. Both Mulligan mobilization with movement (MMWM) and exercise protocols are effective for chronic PF. Furthermore, The Mulligan concept seems more effective treatment option in reducing kinesiophobia and improving functional capacity

Is Non-Weight-Bearing Necessary? (INWN) is a pragmatic multicentre randomised controlled trial comparing immediate protected weight-bearing (IWB) with non-weight-bearing cast immobilisation (NWB) following ankle fracture fixation (ORIF). This trial compares; functional outcomes, complication rates and performs an economic analysis to estimate cost-utility. IWB within 24hrs was compared to NWB, following ORIF of all types of unstable ankle fractures. Skeletally immature patients and tibial plafond fractures were excluded. Functional outcomes were assessed by the Olerud-Molander Ankle Score (OMAS) and RAND-36 Item Short Form Survey (SF-36) taken at regular follow-up intervals up to one year. A cost-utility analysis via decision tree modelling was performed to derive an incremental cost effectiveness ratio (ICER). A standard gamble health state valuation model utilising SF-36 scores was used to calculate Quality Adjusted Life Years (QALYs) for each arm. We recruited 160 patients (80 per arm), aged 15 to 94 years (M = 45.5), 54% female. Complication rates were similar in both groups. IWB demonstrated a consistently higher OMAS score, with significant values at 6 weeks (MD=10.4, p=0.005) and 3 months (MD 12.0, p=0.003). Standard gamble utility values demonstrated consistently higher values (a score of 1 equals perfect health) with IWB, significant at 3 months (Ẋ = 0.75 [IWB] / 0.69 [NWB], p=0.018). Cost-utility analysis demonstrated NWB is €798.02 more expensive and results in 0.04 fewer QALYs over 1 year. This results in an ICER of −€21,682.42/QALY. This negative ICER indicates cost savings of €21,682.42 for every QALY (25 patients = 1 QALY gain) gained implementing an IWB regime. IWB demonstrates a superior functional outcome, greater cost savings and similar complication rates, compared to NWB following ankle fracture fixation

Background. In the UK, over 160,000 total joint replacements are performed annually. About 1% of patients subsequently develop a deep bacterial infection and, if untreated, this can result in severe pain, disability, and death. Costs to the NHS are substantial. The INFORM (Infection Orthopaedic Management) programme aims to address gaps in knowledge relating to treatment of deep prosthetic joint infection through six work packages. The programme is supported by a patient forum and patient-partners working on oversight groups. Methods. Literature reviews and meta-analysis of individual patient data from cohort studies of patients treated for prosthetic hip infection. Analysis of the National Joint Registry to observe trends in infection rates, and identify risk markers for infection and effective treatments. Qualitative interviews with patients and health professionals exploring the impact of infection and its treatment. A multicentre randomised controlled trial to compare patient-centred outcomes after one- or two-stage revision for prosthetic hip infection. An economic evaluation to assess cost-effectiveness of treatments. A survey of patients to explore individuals’ preferences for treatments. Results. Individual patient data has been provided by UK and international centres. Data on over 1.4 million procedures is available from the National Joint Registry. Interviews conducted with 19 patients with prosthetic hip infection and 12 treating surgeons. Information has advised randomised controlled trial methodology. Seven major UK centres recruiting patients to the INFORM randomised controlled trial. Methods for assessment of costs from a health service and societal perspective developed for the randomised controlled trial. Qualitative studies have contributed to the design of a discrete choice questionnaire. Conclusions. Findings from INFORM will establish how patient care and outcomes can be optimised after prosthetic joint infection. Guidance on best clinical practice will be developed. Level of evidence 1–3. Funding statement This abstract presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (grant number: RP-PG-1210-12005). The views expressed in this abstract are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health

Abstract. Objectives. Intra-articular corticosteroid injections (IACIs) are a well-established non-surgical treatment for the symptoms of osteoarthritis (OA), which can provide short-term improvements in pain, disability and quality of life (QoL). Many patients receive recurrent IACIs as temporary relief of their symptoms. Longer-term outcomes for recurrent IACIs remain less well-researched. This meta-analysis aimed to investigate the longer-term risks and benefits of IACIs beyond 3 months. Methods. We searched MEDLINE, EMBASE, and CENTRAL from inception to January 07, 2021, for randomised controlled trials (RCTs) where patients with OA had received recurrent IACIs. Our primary outcomes were pain and function. Secondary outcomes included QoL, disease progression, radiological changes, and adverse events. Mean differences with 95% confidence intervals were reported. Results. Ten RCTs met eligibility criteria (eight for knee OA [n=378], two for trapeziometacarpal OA [n=57]). Patients received 2–5 injections. Follow-up ranged from 6–24 months. Patients with knee OA showed mild improvement in pain at 3, 6, and 9 months but not at 12 months post-injection compared to baseline. Improvements in function were seen from 3–24 months post-injection, decreasing over time. Improvements in QoL continued at 24 months. For patients with trapeziometacarpal OA, mild improvements in pain, function, and QoL were demonstrated at 3–6 months (and 12 months for pain) compared to baseline. No serious adverse events were recorded. No studies reported on time-to-future interventions, or risk of future periprosthetic joint infection. Conclusions. Only mild improvements in pain, function, and QoL were noted after recurrent IACIs up to 6–24 months post-injection. Existing RCTs on recurrent IACI lacks sufficient follow-up data to assess disease progression and time-to-future interventions. These results will inform the RecUrrent Intra-articular Corticosteroid injections in Osteoarthritis (RUbICOn) study which aims to establish the long-term safety outcomes of IACI through data linkage of clinical practice data, hospital episode statistics, and national PROMs

Abstract. Objectives. Tendon and ligament injury poses an increasingly large burden to society. With surgical repair and grafting susceptible to high failure rates, tissue engineering provides novel avenues for treatment. This systematic review explores in vivo evidence whether mesenchymal stem cell-derived extracellular vesicles (MSC-EVs) can facilitate tendon and ligament repair in animal models. Methods. On May 26th 2021, a systematic search was performed on PubMed, Web of Science, Cochrane Library, Embase, using search terms ‘mesenchymal stem cell’ or ‘multipotent stem cell’ AND ‘extracellular vesicles’ or ‘exosomes’ AND ‘tendon’ or ‘ligament’ or ‘connective tissue’. Risk of bias was assessed using SYstematic Review Center for Laboratory animal Experimentation (SYRCLE) tool. Studies administering EVs isolated from human or animal-derived MSCs into in vivo models of tendon/ligament injury were included. In vitro, ex vivo, in silico studies were excluded, and studies without a control group were excluded. Data on isolation and characterisation of MSCs and EVs, and in vivo findings in animal models were extracted. Results. Out of 383 relevant studies, 11 case-control studies were included for data extraction, including a total of 448 animal subjects (range 10–90). Six studies utilised bone marrow-derived MSCs. All studies characterised their MSCs via flow cytometry, which expressed CD44 and CD90, and isolated EVs via ultracentrifugation (average diameter 125nm). Five studies utilised histological scoring systems, all of which reported a lower score with EV treatment, suggesting improved healing ability. Four studies reported increased anti-inflammatory cytokine expression (IL-10, TGF-β1); three studies reported decreased endogenous M1/M2 macrophage ratio with EV treatment. Eight studies reported increased maximum stiffness, breaking load, tensile strength in EV-treated tendons. Conclusion. MSC-EVs are effective therapeutic agents for tendon/ligament pathologies, attenuating the initial inflammatory response, and accelerating tendon matrix regeneration. Future randomised controlled trials are needed to definitely demonstrate MSC-EVs superiority in management of tendon/ligament injury

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

Introduction and Objective. Kinesiophobia, the fear of physical movement and activity related to injury vulnerability, has been linked to sub-optimal outcomes following total knee replacement (TKR). This systematic review has two aims: to define the relationship between kinesiophobia and functional outcomes, pain and range of motion following TKR, and to evaluate published treatments for kinesiophobia following TKR. Materials and Methods. A primary search was performed in March 2020. English-language studies recruiting adult primary TKR patients, using the Tampa Scale of Kinesiophobia (TSK) were included. Study quality was assessed using the Newcastle Ottawa Scale for cohort or case control studies, and the Cochrane Collaboration Risk of Bias tool for randomised controlled trials. Results. All thirteen included papers (82 identified) showed adequately low risk of methodological bias. TSK1 (activity avoidance) correlated with WOMAC functional score at 12 months in three studies (r=0.20 p<0.05, R=0.317 p=0.001, and correlation coefficient 0.197 p=0.005). TSK score significantly correlated with mean active range of motion (ROM) at six months (105.33 (SD=12.34) vs 85.53 (SD=14.77) p=0.000) post-operation. Three post-operative interventions improved TSK score vs control following TKR: a home-based functional exercise programme (TSK −14.30 (SD=0.80) vs −2.10 (SD=0.80) p<0.001)), an outpatient CBT programme (TSK 27.76 (SD=4.56) vs 36.54 (SD=3.58), and video-based psychological treatment (TSK 24 (SD=5) vs 29 (SD=5) p<0.01). Conclusions. Kinesiophobia negatively affects functional outcomes up until one year post-operatively, while active ROM is reduced up to six months post procedure. Post-operative functional and psychological interventions can improve kinesiophobia following TKR

Introduction and Objective. Tranexamic acid (TXA) is used across surgical specialties to reduce perioperative bleeding. It has been shown to be effective in trauma, spinal surgery, and lower limb arthroplasty. The aim of this study is to investigate the clinical effectiveness of TXA in all types of shoulder surgery on bleeding and non-bleeding related outcomes. Materials and Methods. This study was registered prospectively on the PROSPERO database (ref: CRD42020185482). A systematic review and meta-analysis of randomised controlled trials (RCTs) investigating intra-operative use of TXA versus placebo in any type of surgery to the shoulder girdle. Electronic databases searched included MEDLINE, EMBASE, PsychINFO, and the Cochrane Library. Risk of bias within studies was assessed using the Cochrane risk of bias v2.0 tool and Jadad score. Certainty of findings were reported using the GRADE approach. The primary outcome was total blood loss. Secondary outcomes included patient reported outcome measures, adverse events, and rate of blood transfusion. Results. Eight RCTs were included in the systematic review and data from 7 of these studies pooled in the meta-analysis. A total of 708 patients were randomized across the studies (406 received TXA, 302 received placebo). Studies included patients undergoing anatomic or reverse total shoulder arthroplasty, open Latarjet surgery, and arthroscopic rotator cuff repair. Pooled analysis demonstrated significant reduction in perioperative bleeding with TXA compared to controls; estimated total blood loss (mean difference [MD], −209.66; 95% CI −389.11 to −30.21; p=0.02), and post-operative blood loss (via drain output) (MD, −84.8ml; 95% CI, −140.04 to −29.56; p=0.003). A mean difference in Visual Analogue Scale (VAS) of 2.93 was noted in favour of TXA (95% CI 0.2 to 5.66; p=0.04). Conclusions. Whilst noting some risk of bias within the studies, TXA was effective in reducing blood loss and pain in shoulder surgery. There may be a benefit of TXA use in both open and arthroscopic shoulder procedures. Larger, low risk of bias, RCTs for specific surgical shoulder procedures are required

Objectives. The evidence base to inform the management of Achilles tendon rupture is sparse. The objectives of this research were to establish what current practice is in the United Kingdom and explore clinicians’ views on proposed further research in this area. This study was registered with the ISRCTN (ISRCTN68273773) as part of a larger programme of research. Methods. We report an online survey of current practice in the United Kingdom, approved by the British Orthopaedic Foot and Ankle Society and completed by 181 of its members. A total of ten of these respondents were invited for a subsequent one-to-one interview to explore clinician views on proposed further research in this area. Results. The survey showed wide variations in practice, with patients being managed in plaster cast alone (13%), plaster cast followed by orthoses management (68%), and orthoses alone (19%). Within these categories, further variation existed regarding the individual rehabilitation facets, such as the length of time worn, the foot position within them and weight-bearing status. The subsequent interviews reflected this clinical uncertainty and the pressing need for definitive research. Conclusions. The gap in evidence in this area has resulted in practice in the United Kingdom becoming varied and based on individual opinion. Future high-quality randomised trials on this subject are supported by the clinical community. Cite this article: Bone Joint Res 2015;4:65–9

Introduction and Objective. Ankle fractures are common and affect young adults as well as the elderly. An unstable ankle fracture treatment typically involves surgical fixation, immobilisation, and modified weight-bearing for six weeks. Non-weight bearing (NWB) cast immobilisation periods were used to protect the soft tissue envelope and osteosynthesis. This can have implications on patient function and may reduce independence, mobility and return to work. Newer trends in earlier mobilisation compete with traditional NWB doctrine, and weak consensus exists as to the best postoperative strategy. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Materials and Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury). The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the immediate weight-bearing group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a pulmonary embolism; both were randomised to NWB. Length of hospital stay (LOS) was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusions. There is a paucity of quality evidence supporting the postoperative management regimes used most commonly in clinical practice. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. In this large multicentre, randomised controlled trial, we investigated immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome. Once anatomical reduction and stable internal fixation is achieved, we recommend IWB in all types of ankle fractures in a compliant patient

Objectives. Pilon fractures represent one of the most surgically challenging fractures in orthopaedics. Different techniques exist for their management, with open reduction and internal fixation (ORIF) and External fixation (Ex-Fix) the most widely used. Whilst there is a plethora of data regarding these strategies for Pilon fractures as a whole, very limited data exists solely on the management of open Pilon fractures. This study aimed to elucidate how surgical management options can influence postoperative complications, and if this can influence future management protocols. Materials and methods. We conducted a search in PubMed, EMBASE and CENTRAL for postoperative complications and functional outcomes in open pilon fractures in those treated with Ex-Fix vs ORIF (PROSPERO-CRD42020184213). The postoperative complications measured included non-union, mal-union, delayed union, bone grafting, amputation, osteoarthritis, deep infection and superficial infection. Functional outcomes in the form of the AOFAS score was also measured where possible. We were able to carry out a meta-analysis for both deep infections and non-unions. Results. The search yielded 309 results and a total of 18 studies consisting of 484 patients were included. All fractures included were open, and consisted of 64 Gustilo-Anderson Type I, 148 Type II, 103 Type IIIa, 90 Type IIIb and 9 Type IIIc. 60 Type III fractures could not be further separated and 12 were ungraded. Both ORIF and Ex-Fix were found to have statistically similar AOFAS scores (p=0.682). For all included studies, the Ex-Fix group had significantly higher rates of superficial infections (p=0.001), non-unions (p=0.001), osteoarthritis (p=0.001) and bone grafting (p=0.001). The meta-analysis found no significant difference in non-union (pooled OR=0.25, 95% CI: 0.03 to 2.24, p = 0.44) or deep infection rates (pooled OR=1.35, 95% CI: 0.11 to 16.69, p = 0.12) between the ORIF and Ex-fix groups. Conclusion. Based on our study, while Ex-Fix and ORIF have similar functional outcomes, Ex-Fix appears to have a significantly higher risk of postoperative complications which must be considered by surgeons when choosing surgical management options. Further research, ideally in a randomised control trial format, is required to definitively demonstrate ORIF superiority in the management of open pilon fractures