Introduction. To develop an international guideline (AOGO) about use of osteobiologics in Anterior Cervical Discectomy and Fusion (ACDF) for treating degenerative spine conditions. Method. The guideline development process was guided by AO Spine Knowledge Forum Degenerative (KF Degen) and followed the Guideline International Network McMaster Guideline Development Checklist. The process involved 73 participants with expertise in degenerative spine diseases and surgery from 22 countries. Fifteen systematic reviews were conducted addressing respective key topics and evidence were collected. The methodologist compiled the evidence into GRADE Evidence-to-Decision frameworks. Guideline panel members judged the outcomes and other criteria and made the final recommendations through consensus. Result. Five conditional recommendations were created. A conditional recommendation is about the use of allograft, autograft or a cage with an osteobiologic in primary ACDF surgery. Other conditional recommendations are about use of osteobiologic for single or multi-level ACDF, and for hybrid construct surgery. It is suggested that surgeons use other osteobiologics rather than human bone morphogenetic protein-2 in common clinical situations. Surgeons are recommended to choose one graft over another or one osteobiologic over another primarily based on clinical situation, and the costs and availability of the materials. Conclusion. This AOGO guideline is the first to provide recommendations for the use of osteobiologics in ACDF. Despite the comprehensive searches for evidence, there were few studies completed with small sample sizes and primarily as case series with inherent risks of bias. Therefore high quality clinical evidence is demanded to improve the guideline

We performed this systematic overview on the overlapping meta-analyses that analyzed autologous platelet-rich plasma (PRP) as an adjuvant in the repair of rotator cuff tears and identify the studies which provide the current best evidence on this subject and generate recommendations for the same. We conducted independent and duplicate electronic database searches in PubMed, Web of Science, Scopus, Embase, Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects on September 8, 2021, to identify meta-analyses that analyzed the efficacy of PRP as an adjuvant in the repair of rotator cuff tears. Methodological quality assessment was made using Oxford Levels of Evidence, AMSTAR scoring, and AMSTAR 2 grades and used the Jadad decision algorithm to generate recommendations. 20 meta-analyses fulfilling the eligibility criteria were included. The AMSTAR scores of the included studies varied from 6–10 (mean:7.9). All the included studies had critically low reliability in their summary of results due to their methodological flaws according to AMSTAR 2 grades. The initial size of the tear and type of repair performed do not seem to affect the benefit of PRPs. Among the different preparations used, leucocyte poor (LP)-PRP possibly offers the greatest benefit as a biological augment in these situations. Based on this systematic overview, we give a Level II recommendation that intra-operative use of PRPs at the bone-tendon interface can augment the healing rate, reduce re-tears, enhance the functional outcomes and mitigate pain in patients undergoing arthroscopic rotator cuff repair

It is known that Osteoporosis is the pathology of bone mass and tissue loss resulting in an increase of fragility, risk of fracture occurrence, and risk of fracture recurrence. We noted there was no definitive pathway in our last audit, therefore recommended: availability of the Osteoporosis clinic referral form in an accessible place, the form be filled by the doctor reviewing the patient in the first fracture clinic, and a liaison nurse to ensure these forms were filled and sent to the Osteoporosis clinic. This second audit analyses our Trust's response to these recommendations and effect achieved in Osteoporosis care. We reviewed our local data base from the 7/27/2020 – 10/2/2021 retrospectively for distal radius fractures who were seen in fracture clinic. We analysed a sample size of 59 patients, excluding patients who had already commenced bone protection medications. 67.7% of our patients had neither been on bone protection medications nor recorded referrals and 13.5% were already on bone protection medications when they sustained the fragility fracture. Ten out of the 51 patients were offered referral to the osteoporosis clinic, and one refused. This makes 20% (10 out of 50) of the patients had completed referrals. In comparison, in our first audit, 11% had already been on bone protection medications and 18% had completed referrals. The second cycle showed a slight increase in compliance. Majority of the referrals were completed by Orthopaedic Consultants in both audits and ana awareness increase noted among non-consultants in starting the referral process. Based on our analysis, our Trust has a slight improvement in commencing bone protection medications, associated with slight improvement in completing referrals to the Osteoporosis clinic. Despite our recommendations in the first audit, there is still no easily accessible definitive pathway to ensure our Trust's patients have timely access to bone protection and continued care at the Osteoporosis clinic. We recommend streamlining our recommendations to have a more effective approach in ensuring our Trust meets national guidelines. We will implement a Yes or No question assessment for patients visiting clinic in our electronic database which should assist in referral completions

Hip precautions are currently practiced in three-quarters of trauma hospitals in the UK, despite national recommendations from the ‘Blue Book’ not stating it as a requirement. Valuable therapist time is utilised alongside the need for specialised equipment, which can potentially delay discharge whilst it is being arranged. Objective of this study was to explore the current practice of the use of hip precautions on discharge following hemiarthroplasty for hip fractures. To also explore whether they are necessary and to identify areas for improvement to benefit patient care overall. Online survey distributed to various Trauma and Orthopaedic Departments across the UK. Survey was available over a 4-month period, collecting 55 responses overall. Majority of responses were from trauma and orthopaedic consultants who were aware of the ‘Blue Book’ recommendations. The majority of trusts who responded did not practice hip precautions and did not feel this increased the risk of dislocations on discharge. Recommendations included integration of hip precautions in the post-op advice in coordination with the physiotherapist and information leaflets on discharge regarding hip precautions. Hip precautions were not commonly practiced, for reasons including patient compliance and the inherently stable procedure of a hemiarthroplasty compared to a THR, reducing the need for hip precautions. Hip precautions are not widely regarded as a useful practice for post-hip hemiarthroplasty, viewed as utilising more resources and increasing costs and risk due to increased hospital stay. Thus, this potentially delays discharge overall. A consistent approach should be implemented in treating patients post-hip hemiarthroplasty

The purpose of the this survey study was twofold: 1) to examine different aspects of satisfaction with post-operative care in injured workers who have undergone rotator cuff surgery and 2) to examine the relationship between receiving a newly implemented summary report and the overall satisfaction with surgery and recovery. The clinical communication summary report was given to injured workers following their review assessment to share with the family doctor or other health care providers. The form indicated a need for further assessments or investigations and return to work recommendations. The study involved using a satisfaction survey that examined different aspects of follow-up visit and workers’ opinion about their understanding of the nature of surgery, their progress, clinical management, and usefulness of the newly implemented summery report. Eighty patients completed the questionnaire (mean age: 54 (8), 62(78%) males, of whom 26 (34%) had a rotator cuff decompression and 31 (40%) had a rotator cuff repair with 20 (26%) having both procedures and three missing data. There were no statistically significant relationships between the patient demographics (age, sex or type of surgery) and satisfaction. However, there was a significant correlation between how patients perceived the summary report in terms of helpfulness and the overall satisfaction with surgery (FTE<0.0004, p=0.001) and the satisfaction with recovery (FTE<0.0001, p=0.001). This may indicate that improvement in worker's understanding of their treatment recommendations and restrictions is associated with higher levels of overall satisfaction in this population. Our results indicate a positive linear relationship between expressing a high satisfaction and the helpfulness of the summary report. As part of improving care, adding a summary report may facilitate sharing information with the injured workers, their care providers and their workplace

Neurological complications in oncological and degenerative spine surgery represent one of the most feared risks of these procedures. Multimodal intraoperative neurophysiological monitoring (IONM) mainly uses methods to detect changes in the patient's neurological status in a timely manner, thus allowing actions that can reverse neurological deficits before they become irreversible. The utopian goal of spinal surgery is the absence of neurological complications while the realistic goal is to optimize the responses to changes in neuromonitoring such that permanent deficits occur less frequently as possible. In 2014, an algorithm was proposed in response to changes in neuromonitoring for deformity corrections in spinal surgery. There are several studies that confirm the positive impact that a checklist has on care. The proposed checklist has been specifically designed for interventions on stable columns which is significantly different from oncological and degenerative surgery. The goal of this project is to provide a checklist for oncological and degenerative spine surgery to improve the quality of care and minimize the risk of neurological deficit through the optimization of clinical decision-making during periods of intraoperative stress or uncertainty. After a literature review on risk factors and recommendations for responding to IONM changes, 3 surveys were administered to 8 surgeons with experience in oncological and degenerative spine surgery from 5 hospitals in Italy. In addition, anesthesiologists, intraoperative neuro-monitoring teams, operating room nurses participated. The members participated in the optimization and final drafting of the checklist. The authors reassessed and modified the checklist during 3 meetings over 9 months, including a clinical validation period using a modified Delphi process. A checklist containing 28 items to be considered in responding to the changes of the IONM was created. The checklist was submitted for inclusion in the new recommendations of the Italian Society of Clinical Neurophysiology (SINC) for intraoperative neurophysiological monitoring. The final checklist represents the consensus of a group of experienced spine surgeons. The checklist includes the most important and high-performance items to consider when responding to IONM changes in patients with an unstable spine. The implementation of this checklist has the potential to improve surgical outcomes and patient safety in the field of spinal surgery

AO Spine Guideline for Using Osteobiologics in Spine Degeneration project is an international collaborative initiative to identify and evaluate evidence on existing use of osteobiologics in spine degenerative diseases. It aims to formulate clinically relevant and internationally applicable guidelines ensuring evidence-based, safe and effective use of osteobiologics. The current focus is the use of osteobiologics in anterior cervical discectomy and fusion surgeries. The guideline development is planned in three phases. Phase 1- Evidence synthesis and Recommendation; Phase 2- Guideline with osteobiologics grading and Validation; Phase 3- Guideline dissemination and Development of a clinical decision support tool. The key questions formulating the guidelines for the use of osteobiologics will be addressed in a series of systematic reviews in Phase 1. The evidence synthesized by the systematic reviews will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology, including expert panel discussions to formulate a recommendation. In Phase 2, osteobiologics will be graded based on evidence and the grading will be integrated with the recommendation from Phase 1, and thus formulate a guideline. The guideline will be further validated by prospective clinical studies. In the third phase, dissemination of the proposed guideline and development of a decision support tool is planned. AO-GO aims to bridge an important gap between quality of evidence and use of osteobiologics in spine fusion surgeries. With a holistic approach the guideline aims to facilitate evidence-based, patient-oriented decision-making process in clinical practice, thus stimulating further evidence-based studies regarding osteobiologics usage in spine surgeries

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

Introduction. The heterogeneity of outcomes used in the field of lower limb lengthening surgery (LLLS) affects our ability to synthesize evidence. This hampers robust systematic reviews and treatment recommendations for clinical practice. Ultimately this reduces the impact of research for both patients and healthcare professionals. This scoping review aimed to describe the outcomes and outcome measurement instruments (OMIs) used within the field of LLLS. Method. A systematic literature search of WOS, Scopus, Embase, MEDLINE, and the Cochrane Library identified all studies reporting outcomes in children and adults after LLLS. All outcomes and OMIs were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using the COMET Taxonomy of Outcomes. Result. Data saturation was achieved in 2020. A total of 142 studies were included between 2024-2020, reporting 2964 verbatim outcomes with 663 standardized outcome terms collapsed into 119 outcome headings (subdomains). A total of 29 patient-reported and 26 clinician-reported outcome instruments were identified. The most commonly reported outcome was “Lengthening amount”, reported in over 72% of the included studies, while “health-related quality of life” was measured in 16% and all life impact outcomes were reported in 19% of the included studies. Conclusion. A large number of peer-reviewed publications are available, demonstrating that significant resources are being devoted to research on LLLS. However, reported outcomes for people with LLLS are heterogeneous, subject to reporting bias, and vary widely in the definitions and measurement tools used to collect them. Outcomes likely to be important to patients, such as quality of life and measures of physical function, have been neglected. This scoping review identifies a need to standardize outcomes and outcome measures reported on patients recovering from lower limb lengthening surgery; this can be addressed by creating a core set of outcomes

Nitric oxide is a free radical which in vivo is solely produced during the conversion of the amino acid arginine into citrulline by nitric oxide synthase enzymes. Recently, the importance of nitric oxide on inflammation and bone metabolism has been investigated. However, the knowledge regarding possible in vitro effects of arginine supplementation on chondrogenic differentiation is limited. ATDC5, a cell line which is derived from mouse teratocarcinoma cells and which is characterized as chondrogenic cell line, were proliferated in Dulbecco's Modified Eagle Medium (DMEM)/F12 and subsequently differentiated in proliferation medium supplemented with insulin, transferrin and sodium-selenite and where arginine was added in four different concentrations (0, 7.5, 15 and 30 mM). Samples were harvested after 7 or 10 days and were stored at −80 °C for subsequent RNA isolation for qPCR analysis. To determine chondrogenic differentiation, Alcian Blue staining was performed to stain the proteoglycan aggrecan, which is secreted by differentiated ATDC5 cells. All measurements were performed in triplo. Alcian Blue staining showed a qualitative increase of proteoglycan aggrecan secretion in differentiated ATDC5 cells after treatment with 7 and 15 mM arginine, with additional increased expression of ColII, ColX, Bmp4 and Bmp6. Treatment with 30 mM arginine inhibited chondrogenic differentiation and expression of aforementioned genes, however, Cox-2 and Vegfa gene expression were increased in these samples. Bmp7 was not significantly expressed in any experimental condition. The obtained results are suggestive for a dose-dependent effect of arginine supplementation on chondrogenic differentiation and associated gene expression, with 7.5 and 15 mM as most optimal concentrations and implications for apoptosis after incubation with 30 mM arginine. A future recommendation would be to investigate the effects of citrulline in a similar experiment, as this shows even more promising results to enhance the nitric oxide metabolism in sepsis and bone healing

Excessive opioid prescriptions after total joint arthroplasty (TJA) increase risks for adverse opioid related events, chronic opioid use, and increase the availability of opioids for unlawful diversion. Thus, decreasing postoperative prescriptions may improve quality after TJA. Concerns exist that a decrease in opioids prescribed may increase complications such as readmissions, emergency department (ED) visits or worsened patient reported outcomes (PROs). The purpose of this quality improvement study was to explore whether a reduction in opioids prescribed after TJA resulted in increased complications. Methods: Data originated from a statewide arthroplasty database (MARCQI). The database collects over 96% of all TJA performed in the state of Michigan, USA. Data was prospectively abstracted and included OMEs prescribed at discharge, readmissions, ED visits within 30 days and PROs. Data was collected one year before and after the creation of an opioid prescribing protocol that had decreased prescriptions by approximately 50% in opioid naive and tolerant patients. Trends were monitored using Shewhart control charts. 84,998 TJA over two-years were included. All groups showed a reduction in opioids prescribed. Importantly, no increased complications occurred concomitant to this reduction. No increases in ED visits or readmissions, and no decreases in KOOSJR/HOOSJR/PROMIS10 scores were noted in any of the groups. Using large data sets and registries can drive performance and improve quality. The MARCQI Postoperative opioid prescription recommendations and performance measures decreased total oral morphine equivalents prescribed over a large and diverse population by approximately 50% without decreasing PROs or increasing ED visits or hospital readmissions. A reduction in opioids prescribed after TJA can be accomplished safely and without an increase in complications across a large population

Introduction. Knee arthroplasty (KA), encompassing Total Knee Replacement (TKR) and Unicompartmental Knee Replacement (UKR), is one of the most common orthopedic procedures, aimed at alleviating severe knee arthritis. Postoperative KA management, especially radiographic imaging, remains a substantial financial burden and lacks standardised protocols for its clinical utility during follow-up. Method. In this retrospective multicentre cohort study, data were analysed from January 2014 to March 2020 for adult patients undergoing primary KA at Imperial NHS Trust. Patients were followed over a five-year period. Four machine learning models were developed to evaluate if post-operative X-ray frequency can predict revision surgery. The best-performing model was used to assess the risk of revision surgery associated with different number of X-rays. Result. The study assessed 289 knees with a 2.4% revision rate. The revision group had more X-rays on average than the primary group. The best performing model was Logistic Regression (LR), which indicated that each additional X-ray raised the revision risk by 52% (p<0.001). Notably, having four or more X-rays was linked to a three-fold increase in risk of revision (OR=3.02; p<0.001). Our results align with the literature that immediate post-operative X-rays have limited utility, making the 2nd post-operative X-ray of highest importance in understanding the patient's trajectory. These insights can enhance management by improving risk stratification for patients at higher revision surgery risk. Despite LR being the best-performing model, it is limited by the dataset's significant class imbalance. Conclusion. X-ray frequency can independently predict revision surgery. This study provides insights that can guide surgeons in evidence-based post-operative decision-making. To use those findings and influence post-operative management, future studies should build on this predictive model by incorporating a more robust dataset, surgical indications, and X-ray findings. This will allow early identification of high-risk patients, allowing for personalised post-operative recommendations

The function of the upper extremity is highly dependent on correlated motion of the shoulder. The shoulder can be affected by several diseases. The most common are: rotator cuff tear (RCT), shoulder instability, shoulder osteoarthritis and fractures. Rotator cuff disease is a common disorder. It has a high prevalence rate, causing high direct and indirect costs. The appropriate treatment for RCT is debated. The American Academy Orthopaedic Surgeons guidelines state that surgical repair is an option for patients with chronic, symptomatic full-thickness RCT, but the quality of evidence is unconvincing. Thus, the AAOS recommendations are inconclusive. We are performing a randomized controlled trial to compare surgical and conservative treatment of RCT, in term of functional outcomes, rotator cuff integrity, muscle atrophy and fatty degeneration. Shoulder instability occurs when the head of the upper arm bone is forced out of the shoulder socket. Shoulder instabilities have been classified according to the etiology, the direction of instability, or on combinations thereof. The Thomas and Matsen classification, which is currently the most commonly utilized classification, divides shoulder instability events into the traumatic, unidirectional, Bankart lesion, and surgery (TUBS) and the atraumatic, multidirectional, bilateral, rehabilitation, and capsular shift (AMBRI) categories. The acquired instability overstress surgery (AIOS) category was then added. Surgical procedures for shoulder instability includes arthroscopic capsuloplasty, remplissage, bone block procedure or Latarjet procedure. Reverse total shoulder arthroplasty (RTSA) represents a good solution for the management of patients with osteoarthritis or fracture of the proximal humerus, with associated severe osteoporosis and RC dysfunction

The current, most popular recommendation for cup orientation, namely the Lewinnek box, dates back to the 70's, that is to say at the stone age of hip arthroplasty. Although Lewinnek's recommendations have been associated with a reduction of dislocation, some complications, either impingement or edge loading related, have not been eliminated. Early dislocations are becoming very rare and most of them probably occur in “outlier” patients with atypical pelvic/hip kinematics. Because singular problems usually need singular treatments, those patients need a more specific personalised planning of the treatment rather than a basic systematic application of Lewinnek recommendations. We aim in this review to define the potential impacts that the spine-hip relations (SHRs) have on hip arthroplasty. We highlight how recent improvements in hip implants technology and knowledge about SHRs can substantially modify the planning of a THR, and make the « Lewinnek recommendations » not relevant anymore. We propose a new classification of the SHRs with specific treatment recommendations for hip arthroplasty whose goal is to help at establishing a personalized planning of a THR. This new classification gives a rationale to optimize the short and long-term patient's outcomes by improving stability and reducing edge loading. We believe this new concept could be beneficial for clinical and research purposes

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

Abstract. Objectives. Additive manufacturing has led to numerous innovations in orthopaedic surgery: surgical guides; surface coatings/textures; and custom implants. Most contemporary implants are made from titanium alloy (Ti-6Al-4V). Despite being widely available industrially and clinically, there is little published information on the performance of this 3D printed material for orthopaedic devices with respect to regulatory approval. The aim of this study was to document the mechanical, chemical and biological properties of selective laser sintering (SLS) manufactured specimens following medical device (TOKA®, 3D Metal Printing LTD, UK) submission and review by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Methods. All specimens were additively manufactured in Ti-6Al-4V ELI (Renishaw plc, UK). Mechanical tests were performed according to ISO6892-1, ISO9585 and ISO12107 for tensile (n=10), bending (n=3) and fatigue (n=16) respectively (University of Bath, UK). Appropriate chemical characterisation and biological tests were selected according to recommendations in ISO10993 and conducted by external laboratories (Wickham Labs, UK; Lucideon, UK; Edwards Analytical, UK) in adherence with Good Lab Practise guidelines. A toxicological review was conducted on the findings (Bibra, UK). Results. The mechanical tests demonstrated that the material performed to the specification for conventionally manufactured titanium alloy of this type (ISO5832-3). The toxicology review concluded that there were no significant concerns for the health of the patients identified in this evaluation and implantation of the TOKA® device would not result in a significant health risk to patients. Conclusions. Reflecting on our MHRA experience, additive manufacture of orthopaedic devices is still considered to be a ‘novel’ process by regulatory bodies, requiring additional safety evidence. Despite this, our findings demonstrate that there is no difference, mechanically or chemically, to the traditionally manufactured alloy material. We hope to support the widening use of 3D printed titanium alloy orthopaedic devices by publishing our route to regulatory approval. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

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. Geriatric patients with a fragility fracture of the hip (FFH) are especially prone to sarcopenia with poor functional outcomes and quality of life. We assessed the prevalence of sarcopenia in older South African patients with FFH. Risk factors for sarcopenia were also investigated. Materials and Methods. From August 1 to November 30, 2018, all older patients with FFH were invited to participate. Sarcopenia was diagnosed based on the revised criteria of the European Working Group on Sarcopenia in Older People (EWGSOP2). Handgrip strength (HGS) and muscle strength were assessed. Muscle quantity was determined by dual-energy X-ray absorptiometry. Demographic information was collected, and 25-hydroxyvitamin D (25[OH]D) status was determined. Results. Of the 100 hip fracture cases, 65 were enrolled, and 52% (34/65) were sarcopenic (women: 62%; men: 38%). HGS accurately identified sarcopenia (sensitivity and specificity: 100%). Patients >80 years of age had a prevalence of sarcopenia twice (18/21 [83%]) that of younger patients (18/44 [36%]). Women with sarcopenia were smaller than those without (weight: p < 0.001; height: p < 0.001; body mass index: p¼0.018). Low 25(OH)D was almost universally present, with median 25(OH)D levels significantly lower in the patients with sarcopenia (27 nmol/L [interquartile range {IQR}: 20–39] vs. 40 nmol/L [IQR: 29–53]). Several risk factors, including advanced age; female sex; a smaller body size, especially among women; limited physical activity; and low 25(OH)D levels, were identified. Conclusions. The accuracy of HGS testing in this cohort underscores EWGSOP2's recommendation that muscle strength is key to sarcopenia. Further study and follow-up are required to determine the clinical relevance of sarcopenia among FFH patients. The prevalence of sarcopenia in our FFH population is high. Sarcopenia is associated with poor patient outcomes following surgical intervention. Orthopaedic surgeons should therefore be cognisant of the presentation and associated risk of sarcopenia as our patient populations age

Introduction and Objective. Knee osteoarthritis (KOA) is a frequent disease for which therapeutic possibilities are limited. In current recommendations, the first-line analgesic is acetaminophen. However, low efficacy of acetaminophen, frequently leads to the use of weak opioids (WO) despite their poor tolerance, especially in elderly patients. The primary objective was to compare the analgesic efficacy and safety of a new wearable transcutaneous electrical nerve stimulation (W-TENS) to weak opioids (WO) in the treatment of moderate to severe, nociceptive, chronic pain in knee osteoarthritis patients. Materials and Methods. ArthroTENS study is a phase 3, non-inferiority, multicentric, prospective, randomized, single-blinded for primary efficacy outcome, controlled, in 2-parallel groups, clinical study comparing W-TENS versus WO over a 3-month controlled period with an additional, optional, non-controlled, 3-month follow-up for patients in W-TENS group. The co-primary outcome was KOA pain intensity (PI) at month 3 and the number of adverse events (AEs) over 3 months. Results. The non-inferiority of W-TENS was demonstrated in both the PP and ITT populations. At M3, PI in PP population was 3.87 (2.12) compared to 4.66 (2.37) (delta: −0.79 (0.44); 95% CI (−1.65; 0.08)) in W-TENS and WO groups, respectively. Since the absolute value of the 95% CI of the between-treatments mean PI difference [−1.71, – 0.12] was above 0 in ITT set, the planned superiority analysis was performed, demonstrating that W-TENS was significantly superior to WO at M3 (P=0.0124). At M1 and M3, the W-TENS group reached the absolute minimal clinically important difference (MCID) for an analgesic (1.8 (2.1) and 2.1 (2.3), respectively), corresponding to a 20 mm reduction in PI (interquartile range: 15–30) on a 0–100 mm visual analogic scale – i.e. 2 points on a numerical rating scale – which equates to “much better”. Conversely, in the WO group, a 0.5 (1.8) and a 1.1 (2.1) reduction in PI were observed at M1 and M3, respectively, while a 1-point reduction in PI is required to be considered as a “slightly better” improvement. In WO group, AEs were the common systemic AEs reported with WO (nausea, constipation, drowsiness, dizziness, pruritus, vomiting, dry mouth). AEs in W-TENS group were local, such as local cutaneous reaction (erythema). Thirty-nine (70.9%) patients wished to extend W-TENS treatment for 3 additional months. Only one patient discontinued this additional period and results were maintained at M6. Conclusions. W-TENS was more effective and better tolerated than WO in the treatment of nociceptive KOA chronic pain and could represent an interesting non-pharmacological alternative to WO