Aims. Osteoarthritis (OA) affecting the thumb carpometacarpal joint (CMCJ) is a common painful condition. In this study, we aimed to explore clinicians’ approach to management with a particular focus on the role of specific interventions that will inform the design of future clinical trials. Methods. We interviewed a purposive sample of 24 clinicians, consisting of 12 surgeons and 12 therapists (four occupational therapists and eight physiotherapists) who managed patients with CMCJ OA. This is a qualitative study using semi-structured, online interviews. Interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results. A total of 14 themes were developed, six of which were developed relating to the clinical management of CMCJ OA: 1) A flexible ‘ladder’ approach starting with conservative treatment first; 2) The malleable role of steroid injection; 3) Surgery as an invasive and risky last resort; 4) A shared and collaborative approach; 5) Treating the whole person; and 6) Severity of life impact influences treatment. The remaining eight themes were developed relating to clinical trial barriers and facilitators: 1) We need to embrace uncertainty; 2) You are not losing out by taking part; 3) It is difficult to be neutral about certain treatments; 4) Difficult to recruit to ‘no treatment’ ; 5) Difficult to recruit to a trial comparing no surgery to surgery; 6) Patients are keen to participate in research; 7) Burden on staff and participants; and 8) A enthusiasm for a variety of potential trial arms. Conclusion. Our findings contribute to a better understanding of how clinicians manage thumb CMCJ OA in their practice settings. Our study also provides useful insights informing the design of randomized clinical trials involving steroid injections and surgery in people with thumb CMCJ OA. Cite this article: Bone Jt Open 2022;3(4):321–331

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840

Aims

The aim of this study was to explore clinicians’ experience of a paediatric randomized controlled trial (RCT) comparing surgical reduction with non-surgical casting for displaced distal radius fractures.

Aims. Orthopaedic surgery requires grafts with sufficient mechanical strength. For this purpose, decellularized tissue is an available option that lacks the complications of autologous tissue. However, it is not widely used in orthopaedic surgeries. This study investigated clinical trials of the use of decellularized tissue grafts in orthopaedic surgery. Methods. Using the ClinicalTrials.gov (CTG) and the International Clinical Trials Registry Platform (ICTRP) databases, we comprehensively surveyed clinical trials of decellularized tissue use in orthopaedic surgeries registered before 1 September 2022. We evaluated the clinical results, tissue processing methods, and commercial availability of the identified products using academic literature databases and manufacturers’ websites. Results. We initially identified 4,402 clinical trials, 27 of which were eligible for inclusion and analysis, including nine shoulder surgery trials, eight knee surgery trials, two ankle surgery trials, two hand surgery trials, and six peripheral nerve graft trials. Nine of the trials were completed. We identified only one product that will be commercially available for use in knee surgery with significant mechanical load resistance. Peracetic acid and gamma irradiation were frequently used for sterilization. Conclusion. Despite the demand for decellularized tissue, few decellularized tissue products are currently commercially available, particularly for the knee joint. To be viable in orthopaedic surgery, decellularized tissue must exhibit biocompatibility and mechanical strength, and these requirements are challenging for the clinical application of decellularized tissue. However, the variety of available decellularized products has recently increased. Therefore, decellularized grafts may become a promising option in orthopaedic surgery. Cite this article: Bone Joint Res 2023;12(3):179–188

Low back pain (LBP) is the main cause of disability worldwide and is primarily triggered by intervertebral disc degeneration (IDD). Although several treatment options exist, no therapeutic tool has demonstrated to halt the progressive course of IDD. Therefore, several clinical trials are being conducted to investigate different strategies to regenerate the intervertebral disc, with numerous studies not reaching completion nor being published. The aim of this study was to analyze the publication status of clinical trials on novel regenerative treatments for IDD by funding source and identify critical obstacles preventing their conclusion. Prospective clinical trials investigating regenerative treatments for IDD and registered on . ClinicalTrials.gov. were included. Primary outcomes were publication status and investigational treatment funding. Fisher's exact test was utilized to test the association for categorical variables between groups. 25 clinical trials were identified. Among these, only 6 (24%) have been published. The most common source of funding was university (52%), followed by industry (36%) and private companies (12%). Investigational treatments included autologous (56%) or allogeneic (12%) products alone or in combination with a carrier or delivery system (32%). The latter were more likely utilized in industry or privately funded studies (Fig. 1, p=0.0112). No significant difference was found in terms of funding regarding the publication status of included trials (Table 1, p=0.9104). Most clinical trials investigating regenerative approaches for the treatment of IDD were never completed nor published. This is likely due to multiple factors, including difficult enrollment, high dropout rate, and publication bias. 3. More accurate design and technical support from stakeholders and clinical research organization (CROs) may likely increase the quality of future clinical trials in the field. For any figures or tables, please contact the authors directly

Aims. The amount of glenoid bone loss is an important factor in deciding between soft-tissue and bony reconstruction when managing anterior shoulder instability. Accurate and reproducible measurement of glenoid bone loss is therefore vital in evaluation of shoulder instability and recommending specific treatment. The aim of this systematic review is to identify the range methods and measurement techniques employed in clinical studies treating glenoid bone loss. Methods. A systematic review of the PubMed, MEDLINE, and Embase databases was undertaken to cover a ten-year period from February 2011 to February 2021. We identified clinical studies that incorporated bone loss assessment in the methodology as part of the decision-making in the management of patients with anterior shoulder instability. The Preferred Reporting Items for Systematic Reviews (PRISMA) were used. Results. A total of 5,430 articles were identified from the initial search, of which 82 studies met the final inclusion criteria. A variety of imaging methods were used: three studies did not specify which modality was used, and a further 13 used CT or MRI interchangeably. There was considerable heterogeneity among the studies that specified the technique used to quantify glenoid bone loss. A large proportion of the studies did not specify the technique used. Conclusion. This systematic review has identified significant heterogeneity in both the imaging modality and method used to measure glenoid bone loss. The recommendation is that as a minimum for publication, authors should be required to reference the specific measurement technique used. Without this simple standardization, it is impossible to determine whether any published paper should influence clinical practice or should be dismissed. Cite this article: Bone Joint J 2022;104-B(1):12–18

Aims. People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial). Methods. An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials. Results. There were 72 respondents, with a response rate of 9.0%. They comprised 39 orthopaedic spine surgeons, 17 neurosurgeons, one pain specialist, and 15 allied health professionals. Most respondents (n = 61,84.7%) chose conservative care as their first-choice management option for all five case vignettes. Over 50% of respondents reported willingness to randomize three of the five cases to either surgery or BCC, indicating a willingness to participate in the future randomized trial. From the respondents, transforaminal interbody fusion was the preferred approach for spinal fusion (n = 19, 36.4%), and the preferred method of BCC was a combined programme of physical and psychological therapy (n = 35, 48.5%). Conclusion. This survey demonstrates that there is uncertainty about the role of lumbar spine fusion surgery and BCC for a range of example patients with severe, persistent LBP in the UK. Cite this article: Bone Jt Open 2024;5(7):612–620

Fracture nonunion is a severe clinical problem for the patient, as well as for the clinician. About 5-20% of fractures does not heal properly after more than six months, with a 19% nonunion rate for tibia, 12% for femur and 13% for humerus, leading to patient morbidity, prolonged hospitalization, and high costs. The standard treatment with iliac crest-derived autologous bone filling the nonunion site may cause pain or hematoma to the patient, as well as major complications such as infection. The application of mesenchymal autologous cells (MSC) to improve bone formation calls for randomized, open, two-arm clinical studies to verify safety and efficacy. The ORTHOUNION * project (ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs) is a multicentric, open, randomized, comparative phase II clinical trial, approved in the framework of the H2020 funding programme, under the coordination of Enrique Gòmez Barrena of the Hospital La Paz (Madrid, Spain). Starting from January 2017, patients with nonunion of femur, tibia or humerus have been actively enrolled in Spain, France, Germany, and Italy. The study protocol encompasses two experimental arms, i.e., autologous bone marrow-derived mesenchymal cells after expansion (‘high dose’ or ‘low dose’ MSC) combined to ceramic granules (MBCP™, Biomatlante), and iliac crest-derived autologous trabecular bone (ICAG) as active comparator arm, with a 2-year follow-up after surgery. Despite the COVID 19 pandemic with several lockdown periods in the four countries, the trial was continued, leading to 42 patients treated out of 51 included, with 11 receiving the bone graft (G1 arm), 15 the ‘high dose’ MSC (200x10. 6. , G2a arm) and 16 the ‘low dose’ MSC (100x10. 6. , G2b arm). The Rizzoli Orthopaedic Institute has functioned as coordinator of the Italian clinical centres (Bologna, Milano, Brescia) and the Biomedical Science and Technologies and Nanobiotechnology Lab of the RIT Dept. has enrolled six patients with the collaboration of the Rizzoli’ 3rd Orthopaedic and Traumatological Clinic prevalently Oncologic. Moreover, the IOR Lab has collected and analysed the blood samples from all the patients treated to monitor the changes of the bone turnover markers following the surgical treatment with G1, G2a or G2b protocols. The clinical and biochemical results of the study, still under evaluation, are presented. * ORTHOUNION Horizon 2020 GA 733288

Aims. Frozen shoulder is a common, painful condition that results in impairment of function. Corticosteroid injections are commonly used for frozen shoulder and can be given as glenohumeral joint (GHJ) injection or suprascapular nerve block (SSNB). Both injection types have been shown to significantly improve shoulder pain and range of motion. It is not currently known which is superior in terms of relieving patients’ symptoms. This is the protocol for a randomized clinical trial to investigate the clinical effectiveness of corticosteroid injection given as either a GHJ injection or SSNB. Methods. The Therapeutic Injections For Frozen Shoulder (TIFFS) study is a single centre, parallel, two-arm, randomized clinical trial. Participants will be allocated on a 1:1 basis to either a GHJ corticosteroid injection or SSNB. Participants in both trial arms will then receive physiotherapy as normal for frozen shoulder. The primary analysis will compare the Oxford Shoulder Score (OSS) at three months after injection. Secondary outcomes include OSS at six and 12 months, range of shoulder movement at three months, and Numeric Pain Rating Scale, abbreviated Disabilities of Arm, Shoulder and Hand score, and EuroQol five-level five-dimension health index at three months, six months, and one year after injection. A minimum of 40 patients will be recruited to obtain 80% power to detect a minimally important difference of ten points on the OSS between the groups at three months after injection. The study is registered under ClinicalTrials.gov with the identifier NCT04965376. Conclusion. The results of this trial will demonstrate if there is a difference in shoulder pain and function after GHJ injection or SSNB in patients with frozen shoulder. This will help provide effective treatment to patients with frozen shoulder. Cite this article: Bone Jt Open 2023;4(3):205–209

Aims. A pragmatic, single-centre, double-blind randomized clinical trial was conducted in a NHS teaching hospital to evaluate whether there is a difference in functional knee scores, quality-of-life outcome assessments, and complications at one-year after intervention between total knee arthroplasty (TKA) and patellofemoral arthroplasty (PFA) in patients with severe isolated patellofemoral arthritis. Methods. This parallel, two-arm, superiority trial was powered at 80%, and involved 64 patients with severe isolated patellofemoral arthritis. The primary outcome measure was the functional section of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 months. Secondary outcomes were the full 24-item WOMAC, Oxford Knee Score (OKS), American Knee Society Score (AKSS), EuroQol five dimension (EQ-5D) quality-of-life score, the University of California, Los Angeles (UCLA) Physical Activity Rating Scale, and complication rates collected at three, six, and 12 months. For longer-term follow-up, OKS, EQ-5D, and self-reported satisfaction score were collected at 24 and 60 months. Results. Among 64 patients who were randomized, five patients did not receive the allocated intervention, three withdrew, and one declined the intervention. There were no statistically significant differences in the patients’ WOMAC function score at 12 months (adjusted mean difference, -1.2 (95% confidence interval -9.19 to 6.80); p = 0.765). There were no clinically significant differences in the secondary outcomes. Complication rates were comparable (superficial surgical site infections, four in the PFA group versus five in the TKA group). There were no statistically significant differences in the patients’ OKS score at 24 and 60 months or self-reported satisfaction score or pain-free years. Conclusion. Among patients with severe isolated patellofemoral arthritis, this study found similar functional outcome at 12 months and mid-term in the use of PFA compared with TKA. Cite this article: Bone Joint J 2020;102-B(3):310–318

Aims. A national screening programme has existed in the UK for the diagnosis of developmental dysplasia of the hip (DDH) since 1969. However, every aspect of screening and treatment remains controversial. Screening programmes throughout the world vary enormously, and in the UK there is significant variation in screening practice and treatment pathways. We report the results of an attempt by the British Society for Children’s Orthopaedic Surgery (BSCOS) to identify a nationwide consensus for the management of DDH in order to unify treatment and suggest an approach for screening. Methods. A Delphi consensus study was performed among the membership of BSCOS. Statements were generated by a steering group regarding aspects of the management of DDH in children aged under three months, namely screening and surveillance (15 questions), the technique of ultrasound scanning (eight questions), the initiation of treatment (19 questions), care during treatment with a splint (ten questions), and on quality, governance, and research (eight questions). A two-round Delphi process was used and a consensus document was produced at the final meeting of the steering group. Results. A total of 60 statements were graded by 128 clinicians in the first round and 132 in the second round. Consensus was reached on 30 out of 60 statements in the first round and an additional 12 in the seond. This was summarized in a consensus statement and distilled into a flowchart to guide clinical practice. Conclusion. We identified agreement in an area of medicine that has a long history of controversy and varied practice. None of the areas of consensus are based on high-quality evidence. This document is thus a framework to guide clinical practice and on which high-quality clinical trials can be developed. Cite this article: Bone Joint J 2023;105-B(2):209–214

Abstract. Background. Autologous chondrocyte implantation is a NICE approved intervention however it involves the morbidity of two operations, a prolonged rehabilitation and substantial healthcare costs. This study describes a novel, one-step, bone marrow (BM) derived mesenchymal stem cell (MSC) transplantation technique for treating knee osteochondral lesions and presents our prospective clinical study investigating the success of this technique in 206 lesions over a 5 year period. Methodology. The surgical technique involves harvesting BM from patients’ anterior superior iliac spines, centrifugation to isolate MSCs and seeding into a type 1 collagen scaffold (SyngenitTM Biomatrix). Autologous fibrin glue is used to secure the scaffold into the defect. Inclusion criteria included patients aged 15 – 55 years old with symptomatic osteochondral lesions >1cm2. Exclusion criteria included patients with ligament instability, uncorrected alignment, inflammatory arthropathy and a Body Mass Index >35 kg/m2. Outcome measures included the Modified Cincinnati Knee Rating System (MCKRS), complications and reoperations. Results. Mean MCKR scores showed statistically significant improvements compared to pre-operative scores at 6 months 58.79 ± 3.5 and 1 year postoperatively 63.82 ± 3.93 with further improvements at 2 years and 5 years which did not reach statistical significance. Survival rates were 97.9%, 94% and 93.2% at 1, 2 and 5 years. Multiple regression analysis identified previous cartilage surgery, microfracture and age as factors affecting MCKRS scores (p < 0.029, 0.001 and 0.030, respectively). Conclusions. One-step BM derived stem cell transplantation demonstrates satisfactory outcomes over a 5 year period

Device-associated bacterial infections are a major and costly clinical challenge. This project aimed to develop a smart new biomaterial for implants that helps to protect against infection and inflammation, promote bone growth, and is biodegradable. Gallium (Ga) doped strontium-phosphate was coated on pure Magnesium (Mg) through a chemical conversion process. Mg was distributed in a graduated manner throughout the strontium-phosphate coating GaSrPO4, with a compact structure and a Ga-rich surface. We tested this sample for its biocompatibility, effects on bone remodeling and antibacterial activities including Staphylococcus aureus, S. epidermidis and E. coli - key strains causing infection and early failure of the surgical implantations in orthopaedics and trauma. Ga was distributed in a gradient way throughout the entire strontium-phosphate coating with a compact structure and a gallium-rich surface. The GaSrPO4 coating protected the underlying Mg from substantial degradation in minimal essential media at physiological conditions over 9 days. The liberated Ga ions from the coatings upon Mg specimens inhibited the growth of bacterial tested. The Ga dopants showed minimal interferences with the SrPO4 based coating, which boosted osteoblasts and undermined osteoclasts in in vitro co-cultures model. The results evidenced this new material may be further translated to preclinical trial in large animal model and towards clinical trial. Acknowledgements: Authors are grateful to the financial support from the Australian Research Council through the Linkage Scheme (ARC LP150100343). The authors acknowledge the facilities, and the scientific and technical assistance of the RMIT University and John Curtin School of Medical Research, Australian National University

Aims. The aim of this study was to describe the demographic details of patients who sustain a femoral periprosthetic fracture (PPF), the epidemiology of PPFs, PPF characteristics, and the predictors of PPF types in the UK population. Methods. This is a multicentre retrospective cohort study including adult patients presenting to hospital with a new PPF between 1 January 2018 and 31 December 2018. Data collected included: patient characteristics, comorbidities, anticoagulant use, social circumstances, level of mobility, fracture characteristics, Unified Classification System (UCS) type, and details of the original implant. Descriptive analysis by fracture location was performed, and predictors of PPF type were assessed using mixed-effects logistic regression models. Results. In total, 720 femoral PPFs from 27 NHS sites were included. PPF patients were typically elderly (mean 79.9 years (SD 10.6)), female (n = 455; 63.2%), had at least one comorbidity (n = 670; 93.1%), and were reliant on walking aids or bed-/chair-bound prior to admission (n = 419; 61.7%). The study population included 539 (74.9%) hip PPFs, 151 (21.0%) knee PPFs, and 30 (4.2%) dividing type PPFs. For hip (n = 407; 75.5%) and knee (n = 88; 58.3%) arthroplasty UCS B type fractures were most common. Overall, 556 (86.2%) were treated in the presenting hospital and 89 (13.8%) required transfer for treatment. Female sex was the only significant predictor of fracture type (A/B1/C type versus B2/B3) for femoral hip PPFs (odds ratio 0.61 (95% confidence interval 0.41 to 0.91); p = 0.014). Sex, residence type, primary versus revision implant PPF, implant fixation, and time between arthroplasty and PPF were not found to predict fracture type for hip PPFs. Conclusion. This multicentre analysis describes patient and injury factors for patients presenting with femoral PPFs to centres across the UK. These patients are generally elderly and frail, comparable to those sustaining a hip fracture. These data can be useful in planning future services and clinical trials. Cite this article: Bone Joint J 2022;104-B(8):987–996

Introduction. Unstable ankle fractures are routinely managed operatively. Due to soft-tissue and implant related complications, there has been recent literature reporting on the non-operative management of well-reduced medial malleolus fractures following fibular stabilisation, but with limited evidence supporting routine application. This trial assessed the superiority of internal fixation of well-reduced (displacement ≤2mm) medial malleolus fractures compared with non-fixation following fibular stabilisation. Methods and participants. Superiority, pragmatic, parallel, prospective randomised clinical trial conducted over a four year period. A total of 154 adult patients with a bi- or trimalleolar fractures were recruited from a single centre. Open injuries and vertical medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at one-year post-randomisation. Complications and radiographic outcomes were documented over the follow-up period. Results. Among 154 participants (mean age, 56.5 years; 119 women [77%]), 144 [94%] completed the trial. At one-year the median OMAS was 80 (IQR, 60–90) in the fixation group compared with 72.5 (IQR, 55–90) in the non-fixation group (p=0.17). Complication rates were comparable. Significantly more patients in the non-fixation group developed a radiographic non-union (20% vs 0%; p<0.001), with the majority (n=8/13) clinically asymptomatic and one patient required surgical re-intervention for this. Fracture type and reduction quality appeared to influence fracture union and patient outcome. Conclusions. In this randomised clinical trial comparing internal fixation of well-reduced medial malleolus fractures with non-fixation, following fibular stabilisation, fixation was not superior according to the primary outcome. However, 1 in 5 patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the future implications require surveillance. These results may support selective non-fixation of anatomically reduced medial malleolus fractures

The World Health Organisation (WHO) has included low back pain in its list of twelve priority diseases. Notably, Degenerative disc disease (DDD) presents a large, unmet medical need which results in a disabling loss of mechanical function. Today, no efficient therapy is available. Chronic cases often receive surgery, which may lead to biomechanical problems and accelerated degeneration of adjacent segments. Our consortium partners have developed and studied mesenchymal stem cell-based, regenerative therapies trials. In previous phase 2 trial, patients exhibited rapid and progressive improvement of functional and pain indexes after 1 year with no significant side effects. To develop the world's first rigorously proven, effective treatment of DDD, EUROSPINE aims to assess, via a multicentre, randomized, controlled, phase 2b clinical trial including 112 patients with DDD, the efficacy of an allogenic intervertebral mesenchymal stem cell (MSC)-based therapy. This innovative therapy aims to rapidly and sustainably (at least 24 months) reduce pain and disability. In addition, the consortium aims to provide new knowledge on immune response & safety associated with allogeneic BM-MSC intradiscal injection. This simple procedure would be cost-effective, minimally invasive, and standardised. At the end of the RESPINE trial, we aim to propose a broadly available and clinically applicable treatment for DDD, marketed by European SMEs

Aims. The aim of this study was to report the pooled prevalence of post-traumatic osteoarthritis (PTOA) and examine whether the risk of developing PTOA after anterior cruciate ligament (ACL) injury has decreased in recent decades. Methods. The PubMed and Web of Science databases were searched from 1 January 1980 to 11 May 2022. Patient series, observational studies, and clinical trials having reported the prevalence of radiologically confirmed PTOA after ACL injury, with at least a ten-year follow-up, were included. All studies were analyzed simultaneously, and separate analyses of the operative and nonoperative knees were performed. The prevalence of PTOA was calculated separately for each study, and pooled prevalence was reported with 95% confidence intervals (CIs) using either a fixed or random effects model. To examine the effect of the year of injury on the prevalence, a logit transformed meta-regression analysis was used with a maximum-likelihood estimator. Results from meta-regression analyses were reported with the unstandardized coefficient (β). Results. The pooled prevalence of PTOA was 37.9% (95% CI 32.1 to 44) for operatively treated ACL injuries with a median follow-up of 14.6 years (interquartile range (IQR) 10.6 to 16.7). For nonoperatively treated ACL injuries, the prevalence was 40.5% (95% CI 28.9 to 53.3), with a median of follow-up of 15 years (IQR 11.7 to 20.0). The association between the year of operation and the prevalence of PTOA was weak and imprecise and not related to the choice of treatment (operative β -0.038 (95% CI -0.076 to 0.000) and nonoperative β -0.011 (95% CI -0.101 to 0.079)). Conclusion. The initial injury, irrespective of management, has, by the balance of probability, resulted in PTOA within 20 years. In addition, the prevalence of PTOA has only slightly decreased during past decades. Therefore, further research is warranted to develop strategies to prevent the development of PTOA after ACL injuries. Cite this article: Bone Joint J 2023;105-B(11):1140–1148

Aims. Modern total knee arthroplasty (TKA) prostheses are designed to restore near normal kinematics including high flexion. Kneeling is a high flexion, kinematically demanding activity after TKA. The debate about design choice has not yet been informed by six-degrees-of-freedom in vivo kinematics. This prospective randomized clinical trial compared kneeling kinematics in three TKA designs. Methods. In total, 68 patients were randomized to either a posterior stabilized (PS-FB), cruciate-retaining (CR-FB), or rotating platform (CR-RP) design. Of these patients, 64 completed a minimum one year follow-up. Patients completed full-flexion kneeling while being imaged using single-plane fluoroscopy. Kinematics were calculated by registering the 3D implant models onto 2D-dynamic fluoroscopic images and exported for analysis. Results. CR-FB designs had significantly lower maximal flexion (mean 116° (SD 2.1°)) compared to CR-RP (123° (SD 1.6°)) and PS-FB (125° (SD 2.1°)). The PS-FB design displayed a more posteriorly positioned femur throughout flexion. Furthermore, the CR-RP femur was more externally rotated throughout kneeling. Finally, individual patient kinematics showed high degrees of variability within all designs. Conclusion. The increased maximal flexion found in the PS-FB and CR-RP designs were likely achieved in different ways. The PS-FB design uses a cam-post to hold the femur more posteriorly preventing posterior impingement. The external rotation within the CR-RP design was surprising and hasn’t previously been reported. It is likely due to the polyethylene bearing being decoupled from flexion. The findings of this study provide insights into the function of different knee arthroplasty designs in the context during deep kneeling and provide clinicians with a more kinematically informed choice for implant selection and may allow improved management of patients' functional expectations. Cite this article: Bone Joint J 2021;103-B(1):105–112

Aims. The aim of this study was to investigate the relationship between the Orthopaedic Trauma Society (OTS) classification of open fractures and economic costs. Methods. Resource use was measured during the six months that followed open fractures of the lower limb in 748 adults recruited as part of two large clinical trials within the UK Major Trauma Research Network. Resource inputs were valued using unit costs drawn from primary and secondary sources. Economic costs (GBP sterling, 2017 to 2018 prices), estimated from both a NHS and Personal Social Services (PSS) perspective, were related to the degree of complexity of the open fracture based on the OTS classification. Results. Adjusted mean total NHS and PSS costs were £13,785 following treatment of complex fractures and £3,550 following treatment of simple fractures, where the open fracture wound is closed at the end of the first wound debridement, generating a mean difference of £10,235 (95% confidence interval £8,074 to £12,396). Conclusion. Following previous work correlating clinical outcomes with the OTS classification of open fractures, this study suggests that the new OTS classification also correlates with economic costs estimated from alternative study perspectives. Cite this article: Bone Joint J 2022;104-B(3):408–412

Objectives. The diagnosis of surgical site infection following endoprosthetic reconstruction for bone tumours is frequently a subjective diagnosis. Large clinical trials use blinded Central Adjudication Committees (CACs) to minimise the variability and bias associated with assessing a clinical outcome. The aim of this study was to determine the level of inter-rater and intra-rater agreement in the diagnosis of surgical site infection in the context of a clinical trial. Materials and Methods. The Prophylactic Antibiotic Regimens in Tumour Surgery (PARITY) trial CAC adjudicated 29 non-PARITY cases of lower extremity endoprosthetic reconstruction. The CAC members classified each case according to the Centers for Disease Control (CDC) criteria for surgical site infection (superficial, deep, or organ space). Combinatorial analysis was used to calculate the smallest CAC panel size required to maximise agreement. A final meeting was held to establish a consensus. Results. Full or near consensus was reached in 20 of the 29 cases. The Fleiss kappa value was calculated as 0.44 (95% confidence interval (CI) 0.35 to 0.53), or moderate agreement. The greatest statistical agreement was observed in the outcome of no infection, 0.61 (95% CI 0.49 to 0.72, substantial agreement). Panelists reached a full consensus in 12 of 29 cases and near consensus in five of 29 cases when CDC criteria were used (superficial, deep or organ space). A stable maximum Fleiss kappa of 0.46 (95% CI 0.50 to 0.35) at CAC sizes greater than three members was obtained. Conclusions. There is substantial agreement among the members of the PARITY CAC regarding the presence or absence of surgical site infection. Agreement on the level of infection, however, is more challenging. Additional clinical information routinely collected by the prospective PARITY trial may improve the discriminatory capacity of the CAC in the parent study for the diagnosis of infection. Cite this article: J. Nuttall, N. Evaniew, P. Thornley, A. Griffin, B. Deheshi, T. O’Shea, J. Wunder, P. Ferguson, R. L. Randall, R. Turcotte, P. Schneider, P. McKay, M. Bhandari, M. Ghert. The inter-rater reliability of the diagnosis of surgical site infection in the context of a clinical trial. Bone Joint Res 2016;5:347–352. DOI: 10.1302/2046-3758.58.BJR-2016-0036.R1

Study aim. There is an ever increasing demand for quality clinical trials in surgery. Surgeons' co-operation and enthusiasm to participate are important, if not crucial in success of such studies, especially if they are multi-centred. Clinician's individual uncertainty (equipoise) about a case has been often cited as an ethical basis for inviting a patient to take part in a clinical trial. This study aims to establish current attitudes of surgeons participating in a national multi-centred randomised controlled trial and explores an on line tool for instant assessment of collective uncertainty (equipoise) for individual clinical cases eligible for a trial. Study design. Surgeons taking part in the UK Heel Fracture Trial were invited to take part. If agreed, they were asked to evaluate treatment prognosis for eligible for the trial anonymised cases of calcaneal fractures online by means of specially designed system. The cases were published on a password protected website on ad-hoc basis during the three years course of the trial. Their responses were submitted instantly on line. Results. 16 out of 24 surgeons agreed to participate. The participating surgeons were emailed links to cases (normally in butches of three) less than once a month. It took them 10-15 min to assess all three cases via interactive interface. Of those who agreed 12 submitted their opinion at least once. 7 voted consistently during the course of the trial. Seventy one cases had been published. The data collected from responses allowed to assess individual and collective uncertainty about clinical cases. 4 surgeons demonstrated tendency towards individual uncertainty, balanced by 4 who did not accept it. However, sufficient collective uncertainty was demonstrated in 84.5% of cases. Discussion. Level of surgeons' enthusiasm towards clinical research appears to be moderate in a selected population of orthopaedic surgeons who already agreed to take part in a randomised clinical trial, despite a very low research time burden of this study. It is important to continue to promote multi-centred studies in order to improve surgeons' attitude towards quality clinical research. Extra efforts by academic clinicians to develop further low research time burden methodologies may increase acceptance and volume of multi-centred clinical research. This study supports previously expressed view that individual uncertainty is a very unreliable and unnecessary justification to offer a subject to take part in a clinical trial. The system used in the study offers surgeons to express their opinions and preferences freely. The instant on line comparison of opinions provides a clear assessment of collective uncertainty, which can be returned to a treating surgeon and a patient him/herself within 48 hours. In absence of collective uncertainty it would be ethical to offer a patient the best treatment according to current opinion. These cases can then be followed up as part of an inclusive trial, if a subject agrees. We believe that using the system may improve decision making process in randomised controlled trials, for example in selected challenging cases

Aims. Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture. Methods. The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group. Conclusion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between low dose single and high dose dual antibiotic-loaded bone cement, which will inform policy and practice guidelines such as the National Institute for Health and Care Excellence guidance on management of hip fractures. Cite this article: Bone Jt Open 2021;2(2):72–78

Aims

The primary aim of this trial was to compare the subsidence of two similar hydroxyapatite-coated titanium femoral components from different manufacturers. Secondary aims were to compare rotational migration (anteversion/retroversion and varus/valgus tilt) and patient-reported outcome measures between both femoral components.

Background. Definitive proof is lacking on mesenchymal stem cell (MSCs) cellular therapy to regenerate bone if biological potential is insufficient. High number of MSCs after GMP expansion may solve the progenitor insufficiency at the injury but clinical trials are pending. Methods. A prospective, multicenter, multinational Phase I/IIa interventional clinical trial was designed under the EU-FP7 REBORNE Project to evaluate safety and early efficacy of autologous expanded MSCs loaded on biomaterial at the fracture site in diaphyseal and/or metaphysodiaphyseal fractures (femur, tibia, humerus) nonunions. The trial included 30 recruited patients among 5 European centres in France, Spain, Germany, and Italy. Safety endpoints (local and general complication rate) and secondary endpoints for early efficacy (number of patients with clinically and radiologically proven bone healing at 12 and 24 weeks) were established. Cultured MSCs from autologous bone marrow, expanded under GMP protocol was the Investigational Medicinal Product, standardised in the participating countries confirming equivalent cell production in all the contributing GMP facilities. Cells were mixed with CE-marked biphasic calcium phosphate biomaterial in the surgical setting, at an implanted dose of 20−106 cells per cc of biomaterial (total 10cc per case) in a single administration, after debridement of the nonunion. Results. Of 30 recruited patients, 28 patients received the treatment and completed the protocol up to 24 weeks (one case pending at submission). No adverse effects related to cells were detected. Two superficial infections associated to musculoskeletal flaps were solved with antibiotics. Preliminary efficacy results at 3 months confirmed 14 consolidations (out of 27 cases, 52%). At 6 months, 20 consolidations (out of 26 cases, 77%) were confirmed. One failure underwent reoperation at 6 months. One case FU was pending at submission. Conclusions. Preliminary results confirm safety, feasibility and efficacy at 3 and 6 months with the described procedure. Level of evidence. II

The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs. Cite this article: Bone Joint Res 2014;3:169–74

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

Aims. Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA. The purpose of this multicentre randomized clinical trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA. Patients and Methods. From six-centres, 233 revision TKAs were randomized to one of four regimens: 1 g of intravenous (IV) TXA given prior to the skin incision, a double-dose regimen of 1 g IV TXA given both prior to skin incision and at time of wound closure, a combination of 1 g IV TXA given prior to skin incision and 1 g of intraoperative topical TXA, or three doses of 1950 mg oral TXA given two hours preoperatively, six hours postoperatively, and on the morning of postoperative day one. Randomization was performed based on the type of revision procedure to ensure equivalent distribution among groups. Power analysis determined that 40 patients per group were necessary to identify a 1 g/dl difference in the reduction of haemoglobin postoperatively between groups with an alpha of 0.05 and power of 0.80. Per-protocol analysis involved regression analysis and two one-sided t-tests for equivalence. Results. In total, one patient withdrew, five did not undergo surgery, 16 were screening failures, and 25 did not receive the assigned treatment, leaving 186 patients for analysis. There was no significant difference in haemoglobin reduction among treatments (2.8 g/dl for single-dose IV TXA, 2.6 g/dl for double-dose IV TXA, 2.6 g/dl for combined IV/topical TXA, 2.9 g/dl for oral TXA; p = 0.38). Similarly, calculated blood loss (p = 0.65) and transfusion rates (p = 0.95) were not significantly different between groups. Equivalence testing assuming a 1 g/dl difference in haemoglobin change as clinically relevant showed that all possible pairings were statistically equivalent. Conclusion. Despite the higher risk of blood loss in revision TKA, all TXA regimens tested had equivalent blood-sparing properties. Surgeons should consider using the lowest effective dose and least costly TXA regimen in revision TKA. Cite this article: Bone Joint J 2019;101-B(Supple 7):10–16

Aims. The aim of this study was to investigate the difference in functional outcome after repair and non-repair of the pronator quadratus muscle in patients undergoing surgical treatment for a distal radial fracture with volar plating. Patients and Methods. A total of 72 patients with a distal radial fracture were included in this randomized clinical trial. They were allocated to have the pronator quadratus muscle repaired or not, after volar locked plating of a distal radial fracture. The patients, the assessor, the primary investigator, and the statistician were blinded to the allocation. Randomization was irreversibly performed using a web application that guaranteed a secure and tamper-free assignment. The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) after 12 months. Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH) score, pronation strength, grip strength, the range of pronation and supination, complications, and the operating time. Results. Of the 72 patients, 63 (87.5%) completed follow-up for the primary outcome measure: 31 (86.1%) from the non-repair group and 32 (88.9%) from the repair group. At the 12-month follow-up, the mean difference in PRWE of 5.47 (95% confidence interval (CI) -4.02 to 14.96) between the repair (mean 18.38 (95% CI 10.34 to 26.41)) and non-repair group (mean 12.90 (95% CI 7.55 to 18.25)) was not statistically significant (p = 0.253). There was a statistically significant difference between pronation strength, favouring non-repair. We found no difference in the other secondary outcomes. Conclusion. We found that repairing pronator quadratus made no difference to the clinical outcome, 12 months after volar plating of a distal radial fracture. We conclude that there is no functional advantage in repairing this muscle under these circumstances and advise against it. Cite this article: Bone Joint J 2019;101-B:1498–1505

Aims

The aims of this study were first, to determine if adding fusion to a decompression of the lumbar spine for spinal stenosis decreases the rate of radiological restenosis and/or proximal adjacent level stenosis two years after surgery, and second, to evaluate the change in vertebral slip two years after surgery with and without fusion.

Our knowledge of primary bone marrow edema (BME) of the knee is still limited. A major contributing factor is that it shares several radiological findings with a number of vascular, traumatic, and inflammatory conditions having different histopathological features and etiologies.

BME can be primary or secondary. The most commonly associated conditions are osteonecrosis, osteochondritis dissecans, complex regional pain syndrome, mechanical strain such as bone contusion/bruising, micro-fracture, stress fracture, osteoarthritis, and tumor. The etiology and pathogenesis of primary BME are unclear. Conservative treatment includes analgesics, non-steroidal anti-inflammatory drugs, weight-bearing limitations, physiotherapy, pulsed electromagnetic fields, prostacyclin, and bisphosphonates. Surgical treatment, with simple perforation, fragment stabilization, combined scraping and perforation, and eventually osteochondral or chondrocyte transplant, is reserved for the late stages. This retrospective study of a cohort of patients with primary BME of the knee was undertaken to describe their clinical and demographic characteristics, identify possible risk factors, and assess treatment outcomes.

We reviewed the records of 48 patients with primary BME of the knee diagnosed on MRI by two radiologists and two orthopedists. History, medications, pain type, leisure activities, smoking habits, allergies, and environmental factors were examined. Analysis of patients’ characteristics highlighted that slightly overweight middle-aged female smokers with a sedentary lifestyle are the typical patients with primary BME of the knee. In all patients, the chief symptom was intractable day and night pain (mean value, 8.5/10 on the numerical rating scale) with active as well as passive movement, regardless of BME extent. Half of the patients suffered from thyroid disorders; indeed, the probability of having a thyroid disorder was higher in our patients than in two unselected groups of patients, one referred to our orthopedic center (odds ratio, 18.5) and another suffering from no knee conditions (odds ratio, 9.8). Before pain onset, 56.3% of our cohort had experienced a stressful event (mourning, dismissal from work, concern related to the COVID-19 pandemic). After conservative treatment, despite the clinical improvement and edema resolution on MRI, 93.8% of patients described two new symptoms: a burning sensation in the region of the former edema and a reduced ipsilateral patellar reflex. These data suggest that even though the primary BME did resolve on MRI, the knee did not achieve full healing.

Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified

Background. The purpose of this multi-center, randomized clinical trial was to compare static and articulating spacers in the treatment of PJI complicating total knee arthroplasty TKA. Methods. 68 Patients treated with two-stage exchange arthroplasty were randomized to either a static (32 patients) or an articulating (36 patients) spacer. A power analysis determined that 28 patients per group were necessary to detect a 13º difference in range of motion between groups. Six patients were excluded after randomization, six died, and seven were lost to follow-up prior to two years. Results. Patients in the static group had a hospital length of stay that was one day greater than the articulating group (6.1 vs. 5.1 days; p=0.032); no other differences were noted perioperatively. At a mean 3.5 years (range, 2.0 to 6.4 years), 49 patients were available for evaluation. Mean motion arc in the articulating group was 113.0º compared to 100.2º in the static group (p=0.001). The mean Knee Society Score was significantly higher in the articulating cohort (79.4 vs. 69.8 points; p=0.043). Although not significantly different with the sample size studied, static spacers were associated with a greater need for an extensile exposure at the time of reimplantation (16.7% vs. 3.8%) and a higher rate of reoperation (33.3% vs. 12.0%). Conclusions. Articulating spacers provided significantly greater range of motion and better clinical outcomes scores. Static spacers also appeared to affect early postoperative rehabilitation, as evidenced by a longer hospital stay following removal of the infected implant and were associated with a trend towards a greater need for extensile exposures at the time of reimplantation. Further, while it has been commonly believed that static spacers would improve infection control, there was no difference in the failure rate secondary to reinfection and there was a trend towards higher risk of reoperation in patients who received a static spacer. When the soft tissue envelope allows and if there is adequate bony support, an articulating spacer is associated with improved outcomes. For figures, tables, or references, please contact authors directly

Background. The purpose of this multicenter, randomized clinical trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss for revision total hip arthroplasty (THA). Methods. Six centers prospectively randomized 155 revisions to one of four regimens: 1g of intravenous (IV) TXA prior to incision, a double dose regimen of 1g IV TXA prior to incision and 1g IV TXA during wound closure, a combination of 1g IV TXA prior to incision and 1g intraoperative topical TXA, or three doses of 1950mg oral TXA administered 2 hours preoperatively, 6 hours postoperatively, and on the morning of postoperative day one. Randomization was based upon revision subgroups to ensure equivalent group distribution, including: femur only, acetabulum only, both component, explant/spacer, and second stage reimplantation. Patients undergoing an isolated modular exchange were excluded. An a priori power analysis (alpha = 0.05; beta = 0.80) determined 40 patients per group were required to identify a 1g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher's exact tests, and two one-sided t-tests for equivalence. Results. Demographic and surgical variables were equivalent between groups. No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (single IV = 3.6 g/dL, double IV = 3.6 g/dL, combined = 3.4 g/dL, and oral = 3.6 g/dL; p = 0.87), calculated blood loss (p = 0.67), or transfusion rates (single IV = 14%, double IV = 20%, combined = 17%, oral = 21%; p = 0.85). Equivalence testing revealed all possible pairings were statistically equivalent, assuming greater than a 1g/dL difference in hemoglobin reduction as clinically relevant. Conclusions. All TXA regimens tested had equivalent blood-sparing properties in the setting of revision THA. Surgeons should consider the lowest effective dose and the most economical regimen. For any tables or figures, please contact the authors directly

Aim. This was a multicenter, randomized, clinical trial to compare the 90-day 1) incidence of surgical site complications (SSC); 2) health care utilization (the number of dressing changes, readmission, and reoperation); and 3) the patient-reported outcomes (PRO) in high-risk patients undergoing revision total knee arthroplasty (rTKA) with postoperative closed incision negative pressure wound therapy (ciNPT) versus a standard of care (SOC) silver-impregnated occlusive dressing. Method. A total of 294 rTKA patients (15 centers) at high-risk for wound complications were prospectively randomized to receive either SOC or ciNPT (n = 147 each). The ciNPT system was adjusted at 125 mmHg of suction. Investigated outcomes were assessed weekly up to 90 days after surgery. A preset interim analysis was conducted at 50% of the intended sample size, with planned discontinuation for clear efficacy/harm if a significance of p < 0.005 was attained. Results. A total of 242 patients completed the required follow-up (ciNPT: n = 124 (84.4%); SOC: n = 118 (80.3%)). Demographics, baseline comorbidities, causes of revision (prosthetic joint infection, aseptic loosening, implant-related, and periprosthetic fractures), and duration of treatment were similar in both cohorts (p > 0.05). Intention to treat analysis demonstrated lower rates of SSC with ciNPT (3.4%) compared to SOC (14.3%) (p = 0.0013) (Table 1 – not included in the proceeding). Similar outcomes were obtained with the modified intention to treat analysis (p = 0.0013). The ciNPT cohort exhibited lower readmission rates (p = 0.0208), and number of dressing changes (p = 0.0003). Conversely, differences in the 90-day incidence of SSI and measured patient-reported outcomes did not reach statistical significance (p > 0.05). Conclusions. ciNPT mitigates the risk of SSC and readmission among high-risk rTKA patients. The lower frequency of dressing changes within the ciNPT cohort may provide added value for healthcare utilization without compromising pain and function. For the table, please contact authors directly

Among the wide variety of bone substitutes presently available, pure β-tricalcium phosphate ceramics have become available (Biosorb®; Aesculap, Tuttlingen). During the first 12 months of a prospective clinical trial, Biosorb® products were implanted in 21 patients. The ceramics were used in a variety of clinical settings, ranging from pelvic osteotomies in children (n=9), to filling of bone cysts or osseous defects (n=4), to dorsal spondylodesis (n=6), as well as for the grafting of pseudarthroses (n=2). Average follow-up period was 13 (6–18) months. The β-TCP granules, when used as part of a composite graft in combination with autologous bone, were completely resorbed after an average period of 14 weeks, while the cubes required 12 to 15 months. The more massive wedges have shown only a decrease in size and radio density. Due to the ability of the cubes and wedges to bear loads of up to 30 MPa, they were successfully implanted during pelvic osteotomies to augment or completely replace the bicortical grafts. Complications or foreign body reactions were not noted. The osseointegration was found to be favorable for all forms. In light of the problems associated with autologous and allogeneic grafts, the use of synthetic bone substitutes will continue to increase. The combination of complete resorption, lack of risk of infection, and load sharing ability make the β-tricalcium phosphate implants a valuable addition to the spectrum of bone replacement products presently available. Their use in pediatric orthopedics could help avoid donor site morbidity including contour changes or growth disturbances, while providing a more stable graft. During the first phase of a prospective clinical trial, we have come to the conclusion, that the β-tricalcium phosphate ceramics represent a real alternative to other bone substitutes

Cite this article: Bone Joint Res 2023;12(6):372–374.

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.

Thermal sensors have been used in bracing research as self-reported diaries are inaccurate. Little is known about new low-profile sensors, optimal location within a brace, locational thermal micro-climate and effect of brace lining. Our objective is to Determine an optimal temperature threshold for sensor-measured and true wear time agreement. Identify optimal sensor location. Assess all factors to determine the best sensor option for the Bracing AdoleScent Idiopathic Scoliosis (BASIS) multicentre RCT.

Seven Orthotimer and five iButton (DS1925L) sensors were synchronised to record temperature at five-minute intervals. Three healthy participants donned a rigid spinal brace, embedded with both sensors across four anatomical locations (abdomen/axilla/lateral-gluteal/sacral). Universal-coordinated-time wear protocols were performed in/out-doors. Intraclass correlation coefficient (ICC) assessed sensor-measured and true wear time agreement at thresholds 15–36oC.

Optimal thresholds, determined by largest ICC estimate: Orthotimer: Abdomen=26oC, axilla=27oC, lateral-gluteal=24.5oC, sacral=22.5oC. iButton: Abdomen=26oC, axilla=27oC, lateral-gluteal=23.5oC, sacral=23.5oC. Warm-up time and error at optimal thresholds increased for moulded sensors covered with 6mm lining.

Location: anterior abdominal wall. Excellent reliability and higher optimal thresholds, less likely to be exceeded by ambient temperature; not a pressure area. Sensor: iButton, longer battery life and larger memory than Orthotimer; allows recording at 10 min intervals for life of brace. Orthotimer only able to record every 30 mins, increasing error between true and measured wear time; Orthotimer needs 6-monthly data download. Threshold: 26oC is optimal threshold to balance warm-up and cool-down times for accurately measuring wear time. Sensor should not be covered by lining foam as this significantly prolongs warm-up time.

Aims

We compared decompression alone to decompression with fusion surgery for lumbar spinal stenosis, with or without degenerative spondylolisthesis (DS). The aim was to evaluate if five-year outcomes differed between the groups. The two-year results from the same trial revealed no differences.

BACKGROUND. Diffuse noxious inhibitory control (DNIC) is impaired in people with chronic pain such as knee osteoarthritis (KOA), which may predict the risk of acute-to-chronic pain transition. Electroacupuncture (EA) is effective in relieving pain in patients with KOA. However, whether EA may inhibit acute-to-chronic pain transition of KOA has not been systematically examined. METHODS. This was a multicenter, three-arm parallel, single-blind randomized controlled trial involving a total of 450 patients with KOA. This study was approved by the Chinese Ethics Committee of Registering Clinical Trials (reference: ChiECRCT-20140035) and registered with Chinese Clinical Trial Registry (ChiCTR-ICR-14005411). Patients were divided into three groups based on EA current intensity: strong EA (>2mA), weak EA (<0.5mA) and sham EA (none acupoint). Treatments consisted of five sessions per week, for two weeks. Primary outcome measures were visual analog scale (VAS) and DNIC function. RESULTS. One week of EA had no clinical important improvement in VAS and DNIC function in all three groups (P>0.05). After 2 weeks” treatment, changes from baseline showed that VAS (strong EA: 2.97, SD 0.10, P<0.0001; weak EA: 2.75, SD 0.15, P <0.0001; sham EA: 1.19, SD 0.14, P<0.0001) and DNIC (strong EA: −14.85, SD 0.16, P<0.0001; weak EA: −4.75, SD 0.28, P<0.0001; sham EA: −1.43, SD 0.24, P<0.0001) were significantly improved in all three groups. Compared with sham EA, weak EA (3.8, 95%CI 3.45 to 4.15) and strong EA (13.54, 95%CI 13.23 to 13.85) were better in improving DNIC function. Compared with weak EA, strong EA were better in enhancing DNIC function (9.73, 95%CI 9.44 to 10.02), as well as in reducing VAS. CONCLUSIONS. In conclusion, EA should be administered 2 weeks to exerting significant effect on KOA. Strong EA was better than weak or sham EA in alleviating the intensity of pain and inhibiting the acute-to-chronic pain transition of KOA

Patients with moderate to severe osteoarthritis of the knee, on a waiting list for total knearthroplasty, were recruited to a double-blind, randomized clinical trial evaluating neoprene knee braces containing high-power static magnets or sham magnets. Patients wore the brace for a minimum of six hours per day and were evaluated at baseline, two, six, twelve and twenty-four weeks. The subjective outcomes (MACTAR, WOMAC, KOOS, SF-36) and functional outcomes (six minute walk, thirty second stair climb) showed no statistically significant differences between the groups at any of the follow-up time periods. The purpose of this study was to compare the effectiveness of neoprene knee braces containing high-power static magnets to sham magnets in the management of osteoarthritis of the knee. No statistically significant difference in patient-related quality-of-life and objective functional evaluation was found between groups. This study provides patients and doctors with evidence as to the efficacy of this type of therapy. It will allow those individuals on fixed incomes to utilize their resources to the best advantage to minimize their symptoms related to osteoarthritis of the knee. A prospective double-blinded randomized clinical trial was conducted. Ninety-five patients with moderate to severe osteoarthritis of the knee were randomized to receive a Magnet (M) or Sham (S) knee brace. Both groups were equal with regards to age (M = 71.1 yrs, S = 66.8yrs), severity of disease, gender and all baseline measures. No statistically significant difference in patient-related quality-of-life and objective functional evaluation was found between groups at any time interval. All study patients were recruited from a knee arthroplasty waiting list. At baseline and at two, six, twelve and twenty-four weeks each patient completed a WOMAC, MACTAR, KOOS quality-of-life questionnaire, SF–36 global health measure, and six minute walk and thirty second stair climb after which they were asked to determine their general fatigue, pain and shortness of breath on a 100mm VAS scale. Patients were instructed to wear their brace at least six hours per day and when active (walking, shopping, golfing)

This randomized clinical trial utilizing the validated rotator cuff disease specific quality of life outcome measure (RC-QOL) and adequate power demonstrates no difference in outcome for full thickness rotator cuff tears comparing open to mini-open surgical techniques. The purpose of the study was to compare standard open rotator cuff repair versus mini-open rotator cuff repair by measuring the disease specific quality of life in patients with rotator cuff injury. This randomized clinical trial utilizing a validated disease specific outcome measure and adequate power demonstrates no difference in outcome for full thickness rotator cuff tears comparing open to mini-open surgical techniques. The miniopen approach utilizing an arthroscoic acromioplasty provides no additional beneifit to the patient undergoing a rotator cuff repair. The mean one year RC-QOL score for the open and mini-open groups were 85.3 (SD = 15.6) and 87.4 (SD = 12.0) out of a maximum of one hundred, respectively. This difference was not statistically significant (p = 0.572). Seventy-two patients (forty-eight males/twenty-four females) with an average age of 56.4 years (thirty-three to eighty-two years) consented to participate in the study. Inclusion criteria involved: unremitting pain, failed conservative treatment of at least three months, weakness of rotator cuff, and positive diagnostic imaging indicating a full-thickness rotator cuff tear. Massive rotator cuff tears were excluded. Prior to surgery, patients were randomized to either open or mini-open rotator cuff repair. Patients were assessed and outcomes were collected at three, six and twelve months after surgery. Primary Outcome Measure: Patient quality of life was quantified using the validated disease specific, reliable and responsive Rotator Cuff Quality of Life Questionnaire (RC-QOL) measured on a one hundred point visual analogue scale format. Secondary Outcomes: Range of motion, strength, American Shoulder and Elbow Surgeons Score, and the Shoulder Rating Questionnaire

Background: Clinical tests used for the detection of knee meniscal tears do not present acceptable diagnostic sensitivity and specificity values. Diagnostic accuracy is improved by arthroscopic evaluation or performing magnetic resonance imaging (MRI) tests. The objective of this study was to evaluate the diagnostic accuracy of a new dynamic clinical examination test for the detection of meniscal tears. Methods: Two hundred and thirteen symptomatic patients with recent knee injuries who all were clinically examined, had MRI tests and underwent arthroscopic surgery and 197 asymptomatic volunteers who all were clinically examined and had MRI tests of their normal knees were included in this study. For clinical examination the medial and lateral joint line tenderness test, McMurray test, Apley compression and distraction test, Thessaly test at 5° and Thessaly test at 20° of flexion were used. For al clinical tests sensitivity, specificity, negative predictive value and diagnostic accuracy rates were calculated against arthroscopic and magnetic resonance imaging data. Results: Thessaly test at 20° of flexion showed a high diagnostic accuracy rate at the level of 94% and a low number of false negative recordings in detecting tears of both the medial and lateral meniscus. Other traditional clinical examination tests, with the exception of joint line tenderness which presented a diagnostic accuracy rate of 88% in detecting lateral meniscal tears, showed inferior rates. Conclusions: Thessaly test at 20° of flexion can be safely used as a first line screening clinical test for the detection of meniscal tears reducing the need and the cost of modern magnetic resonance imaging methods

Introduction: It was hypothesized that ipsilateral upper extremity loading will decrease hip abductor activity by decreasing the adductor moment and thus relieving the symptoms of patients with gluteus medius tendinitis. The aim of the study was to test the hypothesis with a electrophysiological and clinical study. Materials and Methods: Seven voluntary men with no hip complaint were included in the electrophysiological phase of the study. The motor unit activities of the gluteus medius were measured for each subject during the consecutive loading of the ipsilateral, contralateral and both upper extremities, with 2, 3, 5 and 7 kilograms. Seventeen patients (age range 34–67) with acute symptoms of gluteus medius tendinitis were included in the clinical phase of the study. Dynamic VAS scores were recorded for each patient during gait with consecutive loading of the ipsilateral, contralateral and both upper extremities, for each 2, 3, 5 and 7 kilograms. Wilcoxon and Mann-Whitney U tests were used in statistical analysis. The p values below 0.05 were considered significant. Results: In the electrophysiologic study the ipsilateral upper extremity loading with 7 kg in 4 patients, and with 5 and 7 kilograms in 2 patients resulted in a motor unit activities with moderate interference, while motor unit activities with full interference were recorded during all other loadings. The motor unit activity interference scores recorded during the ipsilateral upper extremity loading with 5 kilograms of above, were significantly less then all other loading combinations (p < 0.05). In the clinical study, the ipsilateral upper extremity loading with 3 kilograms and above resulted in significantly less VAS scores then the other loading combinations (p< 0.05). Conclusion: Ipsilateral upper extremity loading decrease the motor unit activity of the ipsilateral gluteus medius muscle and relieves the symptoms of the patients with gluteus medius tendinitis. Ipsilateral upper extremity loading can lead up to new strategies in the rehabilitation of gluteus medius tendinitis

The results of a randomized controlled clinical trial of ninety patients comparing resurfacing to non-resurfacing of the patella in total knee arthroplasty (TKA) are reported with a minimum of ten-years of follow-up. Using a cruciate retaining hybrid TKA, the outcome measures included Knee Society Clinical Rating scores, functional testing (stair climb and flexion extension torques), patient satisfaction, anterior knee pain, and a patellofemoral specific questionnaire. The results indicated no difference between the groups in all categories. Results at two and ten years postoperatively are compared. This study represents the longest follow-up to date comparing resurfacing to nonresurfacing of the patella. Patellar resurfacing in TKA remains controversial. Purpose: To evaluate the results of resurfacing/non-resurfacing of the patella in a randomized controlled clinical trial at a minimum of ten-years of follow-up. One hundred knees (ninety patients) with osteoarthritis were enrolled in a prospective randomized controlled double-blinded trial using the same posterior cruciate retaining total knee replacement. Patients were randomized to resurfacing or nonresurfacing of the patella. Evaluations were performed preoperatively and yearly to a minimum ten years (range, 10.1–11.5 years) postoperatively. Disease specific (Knee Society Clinical Rating System), functional (stair climbing, knee flex-ion/extension torques, patellar examination) outcomes were measured. Patient satisfaction, anterior knee pain, and patellofemoral questionnaires were completed. Intraoperative grading of the articular cartilage was performed. No patients were lost to follow-up; forty-six knees remained alive. Nine revisions (9/90-ten percent) were performed – 7/48 (fifteen percent) in the nonresurfaced and 2/42 (five percent) in the resurfaced group. Three knees in the nonresurfaced group were revised to a resurfaced patella for anterior knee pain. One resurfaced patella was complicated by AVN and fracture, requiring revision. No significant difference was found between the groups regarding revision rates, KSCR score, functional, satisfaction, anterior knee pain, patellofemoral, and radiographic outcomes. Intraoperative cartilage quality was not a predictor of outcome. This study represents the longest follow up to date of a randomized controlled clinical trial to examine patellar resurfacing in TKA. The results showed no significant difference between the groups for all outcome measures at a minimum of ten-years

The results of a randomized controlled clinical trial of ninety patients comparing resurfacing to non-resurfacing of the patella in total knee arthroplasty (TKA) are reported with a minimum of ten-years of follow-up. Using a cruciate retaining hybrid TKA, the outcome measures included Knee Society Clinical Rating scores, functional testing (stair climb and flexion extension torques), patient satisfaction, anterior knee pain, and a patellofemoral specific questionnaire. The results indicated no difference between the groups in all categories. Results at two and ten years postoperatively are compared. This study represents the longest follow-up to date comparing resurfacing to nonresurfacing of the patella. Patellar resurfacing in TKA remains controversial. Purpose: To evaluate the results of resurfacing/non-resurfacing of the patella in a randomized controlled clinical trial at a minimum of ten-years of follow-up. One hundred knees (ninety patients) with osteoarthritis were enrolled in a prospective randomized controlled double-blinded trial using the same posterior cruciate retaining total knee replacement. Patients were randomized to resurfacing or nonresurfacing of the patella. Evaluations were performed preoperatively and yearly to a minimum ten years (range, 10.1–11.5 years) postoperatively. Disease specific (Knee Society Clinical Rating System), functional (stair climbing, knee flexion/extension torques, patellar examination) outcomes were measured. Patient satisfaction, anterior knee pain, and patellofemoral questionnaires were completed. Intraoperative grading of the articular cartilage was performed. No patients were lost to follow-up; forty-six knees remained alive. Nine revisions (9/90-ten percent) were performed – 7/48 (fifteen percent) in the nonresurfaced and 2/42 (five percent) in the resurfaced group. Three knees in the nonresurfaced group were revised to a resurfaced patella for anterior knee pain. One resurfaced patella was complicated by AVN and fracture, requiring revision. No significant difference was found between the groups regarding revision rates, KSCR score, functional, satisfaction, anterior knee pain, patellofemoral, and radiographic outcomes. Intraoperative cartilage quality was not a predictor of outcome. This study represents the longest follow up to date of a randomized controlled clinical trial to examine patellar resurfacing in TKA. The results showed no significant difference between the groups for all outcome measures at a minimum of ten-years

Acute Compartment Syndrome (ACS) is an orthopaedic emergency that can develop after a wide array of etiologies. In this pilot study the MY01 device was used to assess its ease of use and its ability to continuously reflect the intracompartmental pressure (ICP) and transmit this data to a mobile device in real time. This preliminary data is from the lead site which is presently expanding data collection to five other sites as part of a multi-center study.

Patients with long bone trauma of the lower or upper extremity posing a possibility of developing compartment syndrome were enrolled in the study. Informed consent was obtained from the patients. A Health Canada licensed continuous compartmental pressure monitor (MY01) was used to measure ICP. The device was inserted in the compartment that was deemed most likely to develop ACS and ICP was continuously measured for up to 18 hours. Fractures were classified according to the AO/OTA classification. Patient clinical signs and pain levels were recorded by healthcare staff during routine in-patient monitoring and were compared to the ICP from the device. Important treatment information was pulled from the patient's chart to help correlate all of the patient's data and symptoms.

The study period was conducted from November 2020 through December 2021. Twenty-six patients were enrolled. There were 17 males, and nine females. The mean age was 38 years (range, 17–76). Seventeen patients received the device post-operatively and nine received it pre-operatively. Preliminary results show that post-operative ICPs tend to be significantly higher than pre-operative ICPs but tend to trend downwards very quickly. The trend in this measurement appears to be more significant than absolute numbers which is a real change from the previous literature. One patient pre-operatively illustrated a steep trend upwards with minimal clinical symptoms but required compartment release at the time of surgery that exhibited no muscle necrosis. The trend in this patient was very steep and, as predicted, predated the clinical findings of compartment syndrome. This trend allows an early warning signal of the absolute pressure, to come, in the compartment that is being assessed by the device.

Preliminary results suggest that this device is reliable and relatively easy to use within our institutions. In addition it suggests that intracompartmental pressures can be higher immediately post-op but lower rapidly when the patient does not develop ACS. These results are in line with current literature of the difference between pre and post-operative baselines and thresholds of ICP, but are much more striking, as continuous measurements have not been part of the data set in most of past studies.

Further elucidation of the pressure thresholds and profiles are currently being studied in the ongoing larger multicenter study and will add to our understanding of the critical values. This data, plus the added value of continuous trends in the pressure, upwards or downwards, will aid in preventing muscle necrosis during our management of these difficult long bone fractures.

Introduction: In spite of the common occurrence of hallux valgus deformity and the multiple corrective procedures that have been proposed, only few studies have been published about the anatomy of this joint. None of these studies mention the existence of a meniscal structure in the first MTP joint. The fact that this structure is often seen during bunion surgery evoked this study. Material and methods: A hunderd and two human cadaveric feet were dissected primarly to study the anatomy of the first metatarsophalangeal (MTP) joint. The anatomical findings on the specimens were correlated with clinical findings on 100 consecutive hallux valgus procedures. Particular attention was paid to the localization and histology of this meniscal structure. Based on this study, possible associations between the presence of this structure and the pathophysiology of the hallux valgus deformity and chondral lesions are proposed. Results: A meniscal structure was present in 19 percent of the cadavers. A striking negative correlation is found between the presence of a meniscus and the extent of chondral lesions (P < 0.05). The presence of the meniscus was higher in cadavers with hallux valgus deformity (33%), however no significant correlation is found between the occurrence of hallux valgus deformity and the presence of this meniscus (P = 0.2). In our clinical study this meniscus was seen in 40% and was particularly high in younger patients with mild -painful-bunions. Conclusions: The presence of this meniscal structure seems to stabilize the MTP joint, preventing hallux valgus (or rotational ) deformities. Once the rotational deformity increases the meniscus tears becomes painful and slips into the joint. In the more advanced hallux valgus deformity this meniscus plays little function and seems to disappear, leading to arthrosis

Background. The different biodegradable local antibiotic delivery systems are widely used in recent years. The aim of this study was to evaluate the bactericidal activity antibiotic loaded PerOssal pellet in vitro and its effectiveness in the treatment of Staphylococcus aureus induced chronic osteomyelitis. Material and methods. MALDI-TOF have been applied to microbiological diagnosis in patient with osteomyelitis. In most cases, Staphylococcus aureus was isolated. In vitro Ceftriaxone-Loaded PerOssal pellet were placed in middle agar plate containing a stock strain of Staphylococcus aureus. Plates were incubated at 37ºC for 24 hours. The zones of bacterial inhibition were recorded after 24, 48 and 72 hours of incubation. In vivo evaluation was performed by prospectively studying of 21 patients with a clinically and bacteriologically diagnosed Staphylococcus aureus induced osteomyelitis. Mean age was 38±4,2(26 to 53)). After radical surgical debridement and ultrasound cavitation, the bone cavity was full filled with Perosal pellets loaded with different antibiotics depending from the antibiotic sensitivity test. Endpoints were the absence of clinical manifestation of infection or disease recurrence, no need for further surgery. Results. In vitro showed after 24 hrs inhibition zone was 4,2 х 4,9 cm, after 72 hrs the inhibition zone was increased till 7,6 х 8,4 cm. During the subsequent time, there were no changes. Results of the clinical study evidenced no signs of infection in 18 patients (86% (CI 69,8;100)) (p<0,05) at the follow up, while 3 (14%(CI 0;30,2)) (p<0,05) subjects showed infection recurrence at 6 months from operation and 2 of them needed further surgical procedures. Conclusion. PerOssal as an antibiotic carrier stabilizes the action of the antibiotic. This antibiotic carrier system allows to choose an antibiotic individually for each patient according to the antibiotic sensitivity test and can be successfully used in clinical cases of osteomyelitis

Introduction Venous thromboembolic disease is a serious complication of total hip replacement (THR). Use of low-molecular-weight heparin (LMWH) has been shown to reduce the occurrence of deep-vein thrombosis (DVT) significantly, but side effects such as bleeding and thrombocytopenia are frequent. Pneumatic compression with foot-pumps seems to provide the best balance of effectiveness and safety. However, a recent meta-analysis showed that the overall number of patients investigated in randomised clinical trials is too small to draw evidence-based conclusions regarding mechanical prophylaxis of DVT. This trial is a contribution in comparing the effectiveness and safety of mechanical versus chemical prophylaxis of DVT in patients managed with THR. Methods Inclusion criteria were hip osteoarthritis, age less than 80 years, and uninterrupted use of a foot-pump. Exclusion criteria were a history of thromboembolic disease, heart disease, malignancy and bleeding diatheses. Two hundred and sixteen consecutive patients were considered for inclusion in the trial and were randomized either for management with (LMWH) (Fraxiparin, Sanofi -Synthelabo, France) or with the A-V Impulse foot-pump (Orthofix Vascular Novamedix, UK). All patients started mobilisation on crutches with partial weight-bearing on day two using compression stockings. The foot-pump was applied on both feet in the recovery room and was used until patient discharge. Management with the foot-pump was interrupted only during physiotherapy and toileting. A reverse Trendelenburg position (head-high, feet-low) was applied at rest to enhance the pneumatic effect of the pumps. Patients were monitored for DVT using serial duplex sonography (Sonoline Elegra, Siemens, Germany) at day three, 10 and 45 after surgery. Results DVT was detected in three of 100 patients managed with the foot-pump compared with six of 100 patients who received chemical prophylaxis. Sixteen patients did not tolerate continuous use of the foot-pump and were excluded from the study. The average post-operative drainage was 259 ml in the foot-pump group and 328 ml in the control group (p=0.05). Patients with foot-pump had less swelling of the thigh (10 mm compared with 15 mm) (p=0.05). One patient developed heparin-induced thrombocytopenia. Conclusions This study confirms the effectiveness and safety of mechanical prophylaxis of DVT in THR, confirming the outcomes of previous randomized clinical trials. Some patients cannot tolerate the foot-pump, mostly because of sleep disturbance. In relation to the conduct of this study, one or more of the authors is in receipt of a research grant from a non-commercial source

There is an urgent need for the staged, controlled, introduction of new technology and new procedures to surgery. A classification system in four stages is proposed, which would allow for prospective assessment of new devices or methods before they are released for use by the surgical community. The proposal recognises the unique nature of a surgical operation and its learning curve. The issues of randomisation and of informed consent are discussed, and are shown not to be barriers to clinical trials, but necessary adjuncts to orderly testing. The importance of continued surveillance of innovations is emphasised

Aims

A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial.

Traditional mechanical debridement can only remove visibly infected tissue and is unable to completely clear all the biofilm that hides within muscle crevices and nerves. This study aims to determine the results of single-stage revision using noncontact low frequency ultrasonic debridement in treating chronic periprosthetic joint infections (PJI).

A prospective study of consecutive patients requiring single-stage revision for chronic PJI was performed since August 2021. After mechanical debridement, an 8‑mm handheld non‑contact low‑frequency ultrasound probe was used for ultrasonic debridement at a frequency of (25±5) kHz and power of 90% for 5 minutes. Each ultrasound lasted 10 seconds with 3‑seconds intervals. The probe was repeatedly sonicated among all soft tissue and bsingle interface. The distal femoral canal and the posterior capsule of the knee were fully sonicated with a special right‑angle probe. Chemical debridement was then performed to irrigation the whole operative area. Recurrence of infection, culture results and number of colonies 24 hours after ultrasonic debridement were recorded.

A total of 45 patients (25 hips and 20 knees) were included and 43 of them (95.6%) were free of infection at a mean follow-up time of 29 months (24 to 33). There were no intraoperative complications related to ultrasonic debridement (neurovascular and muscle injury, poor wound healing and fat liquefaction). The culture‑positive rate of wound liquid before ultrasonic debridement was 40.0% (18/45), which significantly increased to 75.6% (34/45) after ultrasonic debridement (P=0.001). The median number of colonies 24 hours after ultrasonic debridement was 2372 CFU/ml (310 to 4340 CFU/ml), which was significantly higher than that before debridement (307 CFU/ml; 10 to 980 CFU/ml) (P=0.000).

Single-stage revision with non‑contact low‑frequency ultrasonic debridement can fully expose bacteria within biofilm, increase the efficacy of chemical debridement and lead to a favorable short‑term outcome without related complications.

Abstract

Aims

The aim of this study was to determine the impact of hospital-level service characteristics on hip fracture outcomes and quality of care processes measures.

Introduction: Mobile bearing total knee arthroplasty (TKA) has been developed to theoretically provide better, more physiological function of the knee and produce less PE wear. The theoretical superiority of mobile bearing TKAs over fixed bearing devices has not yet been proven in clinical studies. The objective of the present study was to prospectively analyze clinical and functional outcomes of randomized fixed and mobile bearing total knee arthroplasty patients by means of gait analysis, electromyography and established clinical scores. Methods: In a prospective, randomized, patient- and observer-blinded, clinical study, 33 patients (mean age 63 years) received a cruciate retaining Genesis II TKA for primary osteoarthritis. 16 patients received a mobile bearing and 17 patients a fixed bearing device. The day before surgery and 24 months postoperatively, established clinical (KSS, HSS, WOMAC, UCLA, VAS) and quality of life (SF-36) scores were used to compare both patient groups. Electromyography of standardized locations was measured with the MyoSystem 2000 and analyzed with Myoresearch software. Gait analysis was performed with a six camera motion analysis system and force platforms. Results: Both groups showed significant improvements between pre- and postoperative evaluation in gait analysis and electromyography, but gait analysis results as well electromyography did not show any difference between both groups at follow-up. Clinical and quality of life results significantly improved from pre- to postoperative evaluation, but only the Knee Society Score showed a significant superiority of the mobile bearing group (mean 159.0; SD 27.7; range, 105–196) over the fixed bearing group (mean 134.4; SD 41; range, 56–198) (p=0.0022). Conclusions: In the present study, no functional advantage of mobile bearing TKA over fixed bearing devices could be found, although the mobile bearing group had better clinical results. Thus, long-term clinical results and in-vivo wear analyses have to be followed, and more subtle functional analyses (e.g. fluoroscopy) have to be employed to finally judge over the theoretical advantage of mobile bearing TKAs

Long-term clinical study to explore the curative effect and mechanism of the treatment of adult chronic osteomyelitis by implant Osteoset T. The study object were 65 case adult chronic osteomyelitis patient from November 1977 to April 2003 in a University-based hospital. Age ranged from 18 to 69 years old. 40 cases were treated by general debridement (Method I); 25 cases were treated by general debridement and implant Osteoset T in dead space (Methods II). Stage IA(The UTMB Staging System) osteomyelitis 39 cases; The Organism was Staphylococcus Aureus 28 cases. In all cases (group A), 40 cases were treated with Method I (group AI), 25 cases were treated with Method II (group AII). The majority of the patients, 39 resulted as Stage IA (group B); 22 were treated with Method I (group BI) and 17 cases were treated with Method II (groupBII). Finally, 28 patients were chronic Staph Aureus osteomyelitis (Group C); 13 were treated with Method I (group CI) and 15 cases with Method II (group CII); Followed from 36 to 334 months, mean 75.0 months. Then respectively evaluate and analysis analyze the success rate of different method with standard. The success rate of group BI was 59.09%, group BII was 94.12%, contrast the success rate there was significant difference (p< 0.05). The success rate of group AI was 60.00%, group AII was 80.00%. The success rate of group CI was 46.15%, group CII was 80.00%. The use of Osteoset T has demostrated better healing rate than left the empty cavity there after debridement and irrigation. Osteoset T can local delivery antibiotic, filler of the dead space, It can be mixed with different antibiotics, reduces the hospitalization time, reduces the number of operation. Unfortunately, Osteoset dos not help with the bone growth

A study was made of the mechanics of blood-bearing in a series of patients treated with a cast-brace for fracture of the distal femur. Knee hinges incorporating strain-gauges, a simple force-plate on the floor and a standardised weight-bearing test were used to record axial loads through the cast-brace itself and through the fracture during the phases of healing. The cast-brace carried loads of only 10 to 20 per cent of body weight and functioned mainly as an antibuckling hinged tube. Patterns of weight-bearing recovery showed that the fracture itself limited loads to safe levels. A measure of the recovery of strength at the fracture was determined and termed the "fracture load index". Graphs obtained in this way demonstrated four biomechanical phases of bony union which correlated well with the stages of clinical healing. The clinical application of these results have led to improvements in the design of braces and the use of a cylinder cast-brace for fractures of the distal half of the femoral shaft and of a new type of brace with a hinge at the hip attached to the thigh cast for fractures of the proximal shaft. A simple clinical test is described by which it is possible to monitor the healing of fractures in cast-braces

This randomized clinical trial compares fixed- and mobile-bearing total knee prostheses in terms of the patients’ clinical outcome parameters (Knee Society Clinical Rating, WOMAC, SF-12), range of motion and performance during gait analysis for level-ground walking. Our results show no significant differences in the clinical outcomes and gait performance of the fixed- and mobile-bearing total knee arthroplasties. The purpose of this study was to compare the clinical outcomes and gait parameters of patients with a fixed-bearing or mobile-bearing total knee arthroplasty (TKA). Fifty-five patients were entered into a prospective, randomized clinical trial comparing fixed- versus mobile-bearing TKAs (Genesis II, Smith & Nephew, Memphis, TN). From this patient population, fifteen fixed-bearing and fifteen mobile-bearing TKA patients were matched based on age, sex and BMI to undergo gait analysis. Patients performed trials of level-ground walking at a self-selected velocity while three-dimensional kinetic and kinematic data were collected. The fixed-bearing and mobile-bearing TKA patient groups were comparable regarding Knee Society Clinical Rating (181 ± 22 versus 171 ± 28), WOMAC scores (7 ± 5 versus 9 ± 12), SF-12 and range of motion (121° ± 11° versus 125° ± 6°). Patients with fixed- and mobile-bearing TKAs performed similarly in the gait analysis in terms of their velocity, percent weight acceptance in the operated versus the non-operated limb, peak flexion in stance and swing phases, the support moments and extension moments at the ankle, knee and hip. Decreased peak extension in the mid-stance and swing phases was observed in the operative limb versus the non-operative limb for both fixed- and mobile-bearing TKAs (P=0.02 and 0.04). Decreased peak extension was also observed during mid-stance and swing phases in the mobile-bearing TKAs versus the fixed-bearing TKAs (P=0.064 and 0.052). Fixed-bearing and mobile-bearing TKAs perform similarly in terms of their clinical outcome measures and the kinetics and kinematics of level-ground walking. Funding for this project obtained from Smith & Nephew, Memphis, TN

Introduction and Aims: Problem: Patellar resurfacing in TKA remains controversial. Purpose: To evaluate the results of resurfacing/non-resurfacing of the patella in a randomised controlled clinical trial at a minimum of 10 years of follow-up. Method: One hundred knees (90 patients) with osteoarthritis were enrolled in a prospective randomised controlled double-blinded trial using the same posterior cruciate retaining total knee replacement. Patients were randomised to resurfacing or non-resurfacing of the patella. Evaluations were performed pre-operatively and yearly to a minimum of 10 years (range 10.1–11.5 years) postoperatively. Disease-specific (Knee Society Clinical Rating System), functional (stair climbing, knee flexion/extension torques, patellar examination) outcomes were measured. Patient satisfaction, anterior knee pain, and patellofemoral questionnaires were completed. Intra-operative grading of the articular cartilage was performed. Results: No patients were lost to follow-up; 46 knees remained alive. Nine revisions (9/90–10%) were performed – 7/48 (15%) in the non-resurfaced and 2/42 (5%) in the resurfaced group. Three knees in the non-resurfaced group were revised to a resurfaced patella for anterior knee pain. One resurfaced patella was complicated by AVN and fracture, requiring revision. No significant difference was found between the groups regarding revision rates, KSCR score, functional, satisfaction, anterior knee pain, patellofemoral, and radiographic outcomes. Intraoperative cartilage quality was not a predictor of outcome. Conclusions: This study represents the longest follow-up to date of a randomised controlled clinical trial to examine patellar resurfacing in TKA. The results showed no significant difference between the groups for all outcome measures at a minimum of 10 years

Introduction: Anatomical observation and biomechanical studies have shown that the anterior cruciate ligament (ACL) mainly consists of two distinct bundles, the anteromedial (AM) bundle and posterolateral (PL) bundle. Conventional single-bundle ACL reconstruction techniques have focused on the restoration of the AM bundle while giving limited attention to the PL bundle. The purpose of this prospective, randomize clinical study is to compare the outcomes of ACL reconstruction when using either double-bundle or single-bundle technique and bioabsorbable interference screw fixation, and similar rehabilitation, with both techniques. Methods: Sixty-five patients were randomized into either double-bundle (n = 35) or single-bundle (n=30) ACL reconstruction with hamstring tendons and bio-absorbable screw (Hexalon, Inion Company, Finland) fixation in both group. The evaluation methods were clinical examination, KT-1000 arthrometer measurements, radiographic evaluation, as well as International Knee Documentation Committee (IKDC), and Lysholm knee scores. There were no differences between the study groups preoperatively. For an average of 14 months of follow-up (range, 12 to 20 months), 30 patients of the double-bundle group and 29 patients of the single-bundle group were available (91%). Results: At the follow-up, the rotational stability, as evaluated by pivot shift test, was significantly better in the double-bundle group than in the single-bundle group. Also, the early anterior stability tended to be better with double-bundle technique, although at the 14-month follow-up, no significant difference between the groups was found anymore. In addition, none of the patients in the double-bundle group had graft failure, while four patients in the single-bundle group had. However, knee scores were equal at the follow-up, and all the results were significantly better at the follow-up than preoperatively, in both groups. Conclusions: Rotational stability and early anterior stability were better with double-bundle technique than with single-bundle technique in ACL reconstruction with hamstring autografts and bioabsorbable screw fixation. However, both fixation techniques improved patients’ performance

Purpose: In a prospective randomized clinical trial, we have previously reported the “limb-specific” results comparing operative (plate fixation) versus non-operative (sling) treatment for completely displaced fractures of the shaft of the clavicle. We also sought to determine the effect that a fracture of the shaft of the clavicle had on general health status, as measured by the SF-36 General Health Status instrument. We then evaluated the effects of different treatment methods (operative versus non-operative), on general health scores. Method: We performed a multi-center, randomized clinical trial of operative versus non-operative treatment of completely displaced clavicular shaft fractures in 111 patients. In addition to radiographic, surgeon-based, and limb-specific data we prospectively gathered SF-36 questionnaires at baseline, and at 6 weeks and 3, 6, 12, and 24 months post-injury. Results: Results: Both groups had SF-36 scores equivalent to or slightly superior to population norms at baseline. A clavicular shaft fracture had a significant negative effect on SF-36 scores (especially the physical components) in both groups at 6 weeks (p< 0.01) and 3 months (p< 0.01). There was a statistically greater decrease in Physical Component Scores (PCS) in the non-operative group compared to the operative group (P< 0.05). At 6 months, scores had returned to pre-operative levels in the operative group, but remained significantly decreased in the non-operative group (p=0.04). This difference persisted at the one and two year points. Conclusion: A displaced fracture of the clavicular shaft has a clinically significant negative effect on general health status scores. This effect can be mitigated by primary operative fixation, which restores scores to normal levels by six months post-injury. Patients treated non-operatively for a displaced fracture of the shaft of the clavicle demonstrated lower PCS scores at two years post-injury. This information is useful in counseling patients with regards to treatment options following displaced fractures of the clavicle shaft

Purpose: In a prospective randomized clinical trial, we have previously reported the “limb-specific” results comparing operative (plate fixation) versus non-operative (sling) treatment for completely displaced fractures of the shaft of the clavicle. We also sought to determine the effect that a fracture of the shaft of the clavicle had on general health status, as measured by the SF-36 General Health Status instrument. We then evaluated the effects of different treatment methods (operative versus non-operative), on general health scores. Materials: We performed a multi-center, randomized clinical trial of operative versus non-operative treatment of completely displaced clavicular shaft fractures in 111 patients. In addition to radiographic, surgeon-based, and limb-specific data we prospectively gathered SF-36 questionnaires at baseline, and at 6 weeks and 3, 6, 12, and 24 months post-injury. Results: Both groups had SF-36 scores equivalent to or slightly superior to population norms at baseline. A clavicular shaft fracture had a significant negative effect on SF-36 scores (especially the physical components) in both groups at 6 weeks (p< 0.01) and 3 months (p> < 0.01). There was a statistically greater decrease in Physical Component Scores (PCS) in the non-operative group compared to the operative group (P> < 0.05). At 6 months, scores had returned to pre-operative levels in the operative group, but remained significantly decreased in the non-operative group (p=0.04). This difference persisted at the one and two year points. Conclusions: A displaced fracture of the clavicular shaft has a clinically significant negative effect on general health status scores. This effect can be mitigated by primary operative fixation, which restores scores to normal levels by six months post-injury. Patients treated non-operatively for a displaced fracture of the shaft of the clavicle demonstrated lower PCS scores at two years post-injury

Cost is a factor in the choice of prosthetic components in joint replacement. For a given performance, the least expensive components are the most cost-effective. When evaluating a new prosthesis with an unknown outcome, the use of an economic model allows estimation of potential cost-effectiveness. We used published data for the survival of cemented total hip replacements from Sweden, and cost and demographic information from New South Wales, Australia, in such a model. In young active total hip recipients a new prosthetic design which offered a 90% improvement in survivorship over 15 years and a 15% reduction in the cost of revision surgery, could be sold at a price of 2 to 2.5 times that of conventional cemented components such as the Charnley Low Friction Arthroplasty and still be cost-effective. Using more likely estimates of the improved performance of new technology, however, the upper limit of cost-effectiveness is an increase of 1.5 to 1. Only a very small increase in the cost of a prosthesis could ever be justified for older patients of either sex. Most of the potential benefits of a better level of survivorship appear towards the end of the 15-year period. The results of modelling may be incorporated in clinical trial design. Given the known performance of some well-established and relatively inexpensive designs of prostheses, very large randomised studies would be required to prove an improvement in performance

Many methods have been described over the past 5 years for repair of articular cartilage defects. The best reported results have been from the use of autologous chondrocyte transplantation (ACT)(1) and mosaicplasty.(2) There have, however, been no prospective clinical trials of these two methods. In this trial 70 patients were prospectively randomized to receive either autologous chondrocyte transplantation (37) or mosaicplasty (33) in the knee. 37 patients were female and 33 male. The average age was 32 years (16 – 44). The indications for surgery were persistent pain and mechanical symptoms in the knee with an isolated defect of the articular cartilage. 38 (56%) were post-traumatic, 12 (16%) due to osteochondritis dissecans, 10 (14%) due to previous meniscectomy, and 10 (14%) due to chondromalacia patellae. The size of the defects ranged from 2cm2 to 12cm2 (mean 4.8cm2). There were 35 defects on the medial femoral condyle, 13 on the lateral femoral condyle, 17 on the patella and 5 on the trochlear. 31 patients were undergoing primary surgery and 39 secondary surgery. All were independently reviewed using the Visual Analogue Pain Score, the Cincinatti Pain Score and the Stanmore Score. Patients were arthroscoped at one year with MRI scan and biopsies where possible. Results: The visual analogue pain score improved overall from a mean of 5.4 (range 3.4 – 7.4) pre-operatively to 3.9 (1.8 – 5.1) at one year review. Similarly the Cincinatti pain score improved from 6.5 pre-operatively to 10.2 post-operatively and the Cincinatti function score improved from 46 to 62 at one year before sport commenced. Overall 71% (49) patients were excellent or good on the clinical scoring scales, 15% (11) were fair, and 14% (10) were poor. The 10 poor results were no different from the main group with regard to age, sex, pain level or site or size of lesion. However, 5 were secondary procedures, 2 had multiple lesions, and 3 had had previous ruptured anterior cruciate ligaments. Arthroscopy and biopsy of 21 lesions so far after one year has shown mature articular cartilage in 2, and immature cartilage in 19. In all cases there was bonding of the repair tissue to the underlying bone. This study is already clarifying the role of ACT and mosaicplasty in the management of cartilage defects in the knee and also the necessity for the use of periosteal covering membrane

18 years ago laboratory studies were started to develop a CT-based uncemented customised femoral stem in order to optimise the fixation and strain distribution to the proximal femur in uncemented femoral components. An individual design also aimed to optimise the biomechanics of the joint and to enable use of uncemented stems in femurs with abnormal shape and dimension. The developed prosthesis has now been in clinical use for 13 years. The aim of this paper is to present the preliminary results of a prospective clinical study of this prosthesis. Patients and methods: 685 hips have been operated. 58.8 % of the patients were women. Mean age was 51 years (20–69). 42.3 % of the hips were dysplastic. A high number of hips without major anatomic abnormality of the upper femur were included. The prostheses were designed to obtain a neck anteversion of 10 degrees after insertion, optimised medial femoral head offset and correction of leg length discrepancies up to 3 cm. All patients were followed with radiological and clinical examination. Merle d’Aubigné score was used. RSA and DEXA-studies have been performed in some groups of the patients. Finally, study of the gluteal muscular function in hips with optimised medial femoral head offset after insertion of custom stems was compared to hips where optimisation had not been achieved with use of standard stems. Results: We experienced that use of this type of prosthesis is very simple and offers obvious advantages in abnormal size and geometry of the upper femur. Nine patients sustained a peroperative fissure in the proximal femur (1.3 %). These fissures were treated successfully with cerclage wires. Eight patients sustained a femoral fracture by a fall accident. Four fractures healed after osteosynthesis without loosening of the prosthesis. A long stem pros-thesis had to be used in the other four. No stem loosening was seen except in one case where a non-union after subtrochanteric osteotomy prevented stem fixation. Dislocation occurred in ten hips (1.5%). In four of these the acetabular component had to be replaced. Average total score at 7 years (125 hips) was 17.1 (preop 9.4), at 10 years (56 hips) 17.0 (preop 9.4). The pain scores at the corresponding observations were 5.7 (preop 2.7) and 5.6 (preop 2.8). DEXA-studies showed comparable preservation of femoral bone stock in hips treated with custom and standard stems (ABG). RSA-studies showed no significant stem migration. Superior function of the gluteal muscles was obtained after normalisation of the medial femoral head offset after insertion of a custom stem when compared to hips where normalisation had not been achieved by a standard stem. Conclusions: Use of custom femoral components enables optimisation of the biomechanics of the hip and eliminates the need for highly modular femoral stems. The rate of peroperative fissures and postoperative instability is relatively low indicating adequate fit of the stem and adequate design of the femoral neck. Use of custom prostheses offers obvious advantages in highly abnormal femurs. The mid-term clinical results up to 10 years are promising with a very low risk of aseptic loosening. However, it remains to see whether use of such pros-theses will give superior long term results compared to standard uncemented stems in “normal” femurs

Introduction

Reverse total shoulder arthroplasty (RTSA) is rapidly being adopted as the standard procedure for a growing number of shoulder arthropathies. Though short-term outcomes are promising, mid- and long-term follow-ups present a number of complications – among them, humeral stem and glenosphere component loosening. Though not the primary complication, previously reported aseptic loosening required revision in 100% of cases. As the number of patients undergoing RTSA increases, especially in the younger population, it is important for surgeons to identify and utilize prostheses with stable long-term fixation. It has previously been shown in the hip and knee literature that implant migration in the first two years following surgery is predictive of later failure due to loosening in the 5=10-year postoperative window. The purpose of this study is to, for the first time, evaluate the pattern and total magnitude of implant migration in reverse shoulder arthroplasty using the gold standard imaging technique radiostereometric analysis (RSA).

This prospective controlled clinical trial compares the outcomes of metacarpophalangeal (MCP) arthroplasty in rheumatoid arthritis patients using the Swanson (S) and NeuFlex (N) MCP implants. Forty hands (thirty-seven patients) were randomised and evaluated preoperatively and at one year following MCP arthroplasty in digits two to five for range of motion (ROM; active and passive extension and flexion), ulnar drift and grip strength. Both implants restored extension and corrected flexion deformities. There was no significant difference in extension of all digits (summed) between the NeuFlex and Swanson implants (N: −20.8°; S: −13.8°; p=0.29). The NeuFlex implant, which is pre-flexed at 30°, preserved more flexion at the MCP joint than the Swanson implant in all digits (summed) (N:74.5°; S:55.8°; p=0.005), with the greatest difference observed in the fifth digit (N:69.6°; S:48.7°; p=0.009). The total arc of motion improved in all digits, with no significant differences between the Neu-Flex and Swanson groups in the second through fourth digits (N:53.8°; S:43.8°; p=0.154); a significantly greater improvement was observed in the NeuFlex group for the fifth digit (N:53.3°; S:42.5°; p=0.028). Both implants corrected ulnar drift deformity, while neither led to loss of grip strength. Hand function as measured by Sollerman score and Michigan Hand Questionnaire (MHQ) improved significantly in both groups (p=0.0119, p< 0.0001, respectively) with no significant difference between the Swanson and NeuFlex implants, except for MHQ function, aesthetics, and overall scores, which demonstrated superiority of the Swanson. Overall, there was a significant improvement in the range of motion, deformity and grip strength following MCP arthroplasty for the full patient group. While both implants restored similar amounts of extension, the NeuFlex implant maintained greater flexion and total range of motion, with the greatest difference in the fifth digit. The Swanson implant had better MHQ function and aesthetics subscores

Although new locking plates allows for secure fixation of osteoporotic fractures in the proximal humerus, extensive soft tissue dissection is needed for their insertion. We report on a prospective clinical trial of the first thirty patients treated with plating of the proximal humerus though a minimally invasive percutaneous approach. All fractures healed within the first 6 months with no avascular necrosis or axillary nerve injury. At the latest follow-up, the median Constant score was sixty-eight and the mean DASH score was twenty-seven. This study suggests that percutaneous plating can be a safe and effective method of fixation. To evaluate the safety and efficacy of minimally invasive plating of the proximal humerus using validated disease-specific measures. Percutaneous insertion of a locking proximal humerus plate is safe and produces good early functional and radiologic outcomes. Plate fixation of the proximal humerus fractures may now be more desirable with the use of a biological approach by limiting surgical insult and allowing accelerated rehabilitation. All fractures healed within the first six months with no loss of correction. Two reoperations were needed to remove intra-articular screws placed too long. No infection or avascular necrosis were seen. At the lastest follow-up, the median Constant score was sixty-eight points, with an age ajusted score of seventy-six. The mean DASH score was twenty-seven points. Only age was independantly predictive of both the Constant and DASH functional scores. During a period of one year, thirty patients were operated with use of the LCP proximal humerus plate (Synthes) through a 3cm lateral deltoid splitting approach and a second 2 cm incision at the deltoid insertion. The axillary nerve was palped and easily protected during insertion. Only two-part (N=22) and three-part impacted valgus type (N=8) were included in this study since they can be reduced indirectly thru this percutaneous technique. The average follow-up was thirteen months (eight to twenty months). All patients had the Constant and DASH evaluations

Aims: To compare acetabular surface treatments in alumina on alumina clinical trial. Methods: Utilizing new improved alumina ceramic materials and implant design, 514 hips were implanted in a US IDE prospective randomized study. All patients received the same press-þt hydroxylapatite-coated (HA) femoral stem. Two-thirds (349 hips) received an alumina ceramic bearing surface, while one-third (165 hips) received a cobalt chrome on polyethylene bearing. The alumina group was further divided with approximately one-half receiving a porous-coated titanium shell and alumina insert (172 hips Ð System I), and one-half receiving an arc deposited titanium shell with HA coating and alumina insert (177 hips Ð System II). System III, the control group, had a porous-coated titanium shell and polyethylene insert. All acetabular shells were of identical external geometry. Results: At latest follow-up, minimum 2 years (2–4 year range), differences were noted in the pattern of development of radiolucent lines around the acetabular components. Radiolucent lines were noted most commonly in De Lee Charnley Zone 3 in porous-coated shells (25/164 hips Ð System I, 33/151 hips Ð System III respectively). Radiolucent lines in Zone 3 were absent in the arc deposited with HA shells (System II) (p=0.001). Conclusions: These results appear to demonstrate that PSL style cups with arc dep and HA coating may improve levels of primary þxation versus that of porous-coated acetabular components

This Blinded Randomized Clinical Trial outlines: how peri-articular intra-operative multimodal analgesia significantly reduces post-operative analgesia requirement. Sixty-four patients undergoing total knee replacement were randomised to receive a peri-articular intra-operative injection containing ropivacaine, ketorolac, epimorphine and epinephrine or nothing. Patients who received the injection demonstrated greater satisfaction and pain relief. Finally, patients in the injected group did not show any signs of cardio and central nervous system toxicity. Post-operative analgesia can be associated with troublesome side effects. Good peri-operative analgesia facilitates rehabilitation, improves patient satisfaction and may reduce hospital stay. The purpose of this study was to assess a novel cocktail for peri-articular analgesia after total knee replacement. Sixty-four patients undergoing total knee replacement were randomised to receive a peri-articular intra-operative injection containing ropivacaine, ketorolac, epimorphine and epinephrine or nothing. The anaesthetic analgesic regime was standardised. All patients received patient controlled analgesia (PCA) for twenty-four hours post surgery, followed by standard analgesia. VAS pain scores during activity and at rest and patient satisfaction scores were recorded pre and post operatively and at six week follow up. PCA consumption and overall analgesic requirement were measured. PCA use at six, twelve and over twenty-four hours post surgery was significantly less in patients receiving the injection (p< 0.01, p=0.016, p< 0.01). Patient satisfaction in PACU and four hours post operation was greater (p=0.016, p=0.013). VAS for pain during activity in PACU and at four hours were significantly less (p=0.04, p=0.007) in the injected group. The average ROM at six weeks was no different. Overall hospital stay and the incidence of wound complications were not different between the two groups. Peri-articular intra-operative multimodal analgesia significantly reduces post-operative analgesia requirement. Patient satisfaction and pain relief is greater in the injection group. No cardio and central nervous system toxicity was observed. Our novel cocktail of ketorolac, epimorphine, epinephrine and ropivacaine provides superior pain relief with no adverse side effects

Introduction and Objective

Osteoarthritis of the knee joint is common in old age population in every part of world. Pain is the major source of disability in patients with osteoarthritis of the knee joint. Subchondral bone marrow is richly innervated with nociceptive pain fibers and may be a source of pain in patients with symptomatic degenerative joint disease. Current therapy for managing bone marrow oedema is core decompression (CD), combining core decompression and injection of hydroxyapatite cement or autologus chondrocyte supplementtion. But all of this work has been done in femoral head and authors documented good result with minimal complication. There are various studies in literature suggesting treatment to repair BME by restoring support and relieving abnormal stresses with accepted internal fixation and bone stimulating surgical techniques in relieving knee OA pain. In this study, we present efficacy of knee arthroscopy with adjunctive core decompression and supplementation with structural scaffold to improve self-rated visual analog scale (VAS) pain scores, rate of conversion to arthroplasty, and patient satisfaction levels.

Purpose: To comapre the clinical results and costs of a non-modular, all-polyethylene tibial component versus a modular tibial component in patients older than 70. Methods: A multi-center (London, Ontario; Halifax, Nova Scotia) prospective randomized clinical trial was designed to compare modular metal-backed versus an all polyethylene tibial component in patients over 70 years. Primary outcome measures include Knee Society Clinical Rating System, WOMAC, SF-12, Kaplan-Meier Survivorship. Results: Between September 1995 and August 1997, 127 total knee replacements (Genesis I, Smith & Nephew) were randomized to receive either a non-modular (all-polyethylene) tibial baseplate or a modular (metal-backed) baseplate. Minimum follow-up was 8 years. Excluding patients who died or became disabled due to medical problems, no consistent significant differences have been seen in regard to the WOMAC, SF-12, and Knee Society scores between the two groups. Kaplan-Meier Survivorship is 93% with a mean survival time of 9.36 years for the non-modular group and 94.1% with a mean survival time of 9.49 years for the modular group. The cost saving in the non-modular group was approximately $800 per TKR without any compromise in clinical outcome. Conclusions: There was no difference found in the clinical outcome scores between an all polyethylene tibial baseplate and a modular tibial component in patients over 70 years of age. Non-modular tibial baseplates have a list price of 23–65% the cost of their modular counterparts. A high mortality rate exists in this age group limiting the numbers available for longer term review. The use of an all polyethylene tibial component is a cost effective and clinically successful alternative in the older patient requiring total knee replacement

Purpose: The purpose of this study is to compare the clinical results of a standard polyethylene tibial insert versus the high flex polyethylene tibial insert component designs of a posterior cruciate substituting total knee replacement. Method: One-hundred patients were entered into a prospective, randomized clinical trial comparing standard polyethylene tibial inserts versus the high flex polyethylene tibial insert component designs of posterior cruciate substituting total knee replacement(Genesis II, Smith & Nephew, Memphis, TN). Patients were evaluated pre-operatively, at 3, 12 months and annually thereafter. Patient demographics, radiographs, and multiple outcome measures (WOMAC, SF-12 and the Knee Society Clinical Rating System) were evaluated. Results: No patients were lost to follow-up. One patient died prior to the two year follow up. Ninety- nine patients were reviewed at an average follow-up of 2.7 years (range 2.3 – 3.1 years). There were no significant differences in any outcome measures or radiographic findings. There were no differences in KSCRS at two years (Standard − 170, High Flex −171). There were no differences in knee flexion at 2 years (Standard− 125°, High Flex − 126°). Conclusion: In this prospective randomized clinical trial, no differences could be seen between standard polyethylene and a “Hi- Flex” polyethylene design at a minimum of 2 years follow-up. In particular, no improvement in knee flexion was observed. Long-term evaluation will be required to comment on differences in polyethylene wear and implant longevity

Purpose: The purpose of this clinical trial was to investigate the accuracy of a novel method for computer-assisted distal radius osteotomy, in which computer-generated patient-specific plastic guides were used for intra-operative guidance. Our hypothesis was that these guides combine the accuracy and precision of computer-assisted techniques with the ease of use of mechanical guides. Method: In a consecutive series of 9 patients we tested the accuracy of the proposed method. Prior to surgery, CT scans were obtained of both radii and ulnae in neutral rotation. Three-dimensional virtual models for both the affected and unaffected radius and ulna were created. The models of the unaffected radius and ulna were reflected to serve as a template for the correction. Custom-made software was used to plan the correction. The locations of the distal and proximal drill holes for the plate were saved and the locations of the distal holes before the osteotomy were determined. The design of a patient-specific instrument guide was calculated, into which a mirror image of intra-operative accessible bone structure of the distal radius was integrated. This allowed for unique positioning of the guide intra-operatively. For each planned drill location a guidance hole was incorporated into the guide. A plastic model of the guide was created using a rapid prototyping machine. Intra-operatively, a conventional incision was made and the guide was positioned on the distal end of the radius. The surgeon drilled the holes for the plate screws into the intact radius. The guide was removed and the surgeon performed the osteotomy using the conventional technique and shaved the bone from the distal radius fragment to accommodate the plate. Using the pre-drilled holes the plate was affixed to the distal radius fragment. The distal fragment was reduced until the proximal screw holes in the plate aligned with the pilot holes in the bone. To analyze the accuracy of the intra-operative procedure we compared the post-operative alignment of the radius with the planned alignment. A lateral and an A/P digitally reconstructed radiograph (DRR) of the plan were calculated. These DRRs were used to evaluate the radial inclination, the volar tilt and the ulnar variance of the planned alignment. Post-operative lateral and A/P X-Rays were used to determine the same three post-operative radiographic indices. The post-operative values were compared with the planned values. Results: We found an average deviation for the radial inclination of 0.5°(StDev 1.8), for the volar tilt of 0.7°(StDev 2.3), and for the ulnar variance of 0.8mm (StDev 1.9). Conclusion: These results show that the computer-generated instrument guides accurately achieved the planned alignment. The guides were easy to integrate into the surgical workflow and eliminated the need for intra-operative fluoroscopy for guidance of the procedure

The surgical community is plagued with a reputation for both failing to engage and to deliver on clinical research. This is in part due to the absence of a strong research culture, however it is also due to a multitude of barriers encountered in clinical research; particularly those involving surgical interventions. ‘Trauma’ amplifies these barriers, owing to the unplanned nature of care, unpredictable work patterns, the emergent nature of treatment and complexities in the consent process. This review discusses the barriers to clinical research in surgery, with a particular emphasis on trauma. It considers how barriers may be overcome, with the aim to facilitate future successful clinical research.

Cite this article: Bone Joint Res 2014;3:123–9.

We studied the safety of combining the postoperative use of a non-steroidal anti-inflammatory drug with low-dose heparin. In a double-blind, placebo-controlled clinical trial we reviewed the complications in 235 patients after total hip replacement, all treated with low-dose heparin and either indomethacin or a placebo. The incidence and type of complications in the two groups were nearly equal; indomethacin-treated patients had no increase in complications related to bleeding. Postoperative bleeding into drains was marginally greater in the indomethacin group, although the difference was not statistically significant. We conclude that treatment with indomethacin and low-dose heparin after hip replacement does not significantly increase the bleeding or other complications. We also found that patients receiving indomethacin were mobilised an average of one day before those on placebo

Background: Tibial shaft fractures are the commonest cause of compartment syndromes. Intramedullary nails have been the more accepted treatment. Raised pressures after nailing don’t mean a compartment syndrome, but are an important factor to consider in the decision of treatment. Methods: A clinical study was performed including 80 cases diagnosed of tibial shaft fractures treated with reamed intramedullary nails. Measurement method for compartment pressures was the slit catheter. Pressures were calculated before and just after surgery. Delta P values were calculated too. Patients with overpressures but no clinical suspicion of compartment syndrome were monitored during 24 hours. Patients diagnosed of compartment syndrome were treated by fasciotomy. Descriptive and statistical study was performed with a ninety-five percent confidence intervals and significant difference p< 0,05. Results: A statistical significant raising pressure was observed after surgery. Delta-P values showed a decrease after nailing only in the anterior compartment, but it was not significative (p ≥ 0,05). 4 cases were necessary for monitoring during 24 hours. 11 patients were diagnosed of compartment syndrome after surgery, with absolute pressures that showed values over 30 mm Hg, and delta P less than 40 mmHg. Conclusions: Reamed intramedullary nails can increase compartment pressures in tibial shaft fractures. Delta P value can infiuence decisions for performing a fasciotomy. Diagnosis of a compartment syndrome must be based on clinical findings. If any doubt is present, we recommend pressure measurement, with a cut off value for fasciotomy of delta P ≤ 40 mm Hg. Delaying deffinitive treatment is suggested until pressure values were secure

Aims

To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups.

Introduction

Total shoulder arthroplasty is the fastest growing joint replacement in recent years, with projected compound annual growth rates of 10% for 2016 through 2021 – higher than those of both the hip and knee combined. Reverse total shoulder arthroplasty (RTSA) has gained particular interest as a solution for patients with irreparable massive rotator cuff tears and failed conventional shoulder replacement, for whom no satisfactory intervention previously existed. As the number of indications for RTSA continues to grow, so do implant designs, configurations, and fixation techniques. It has previously been shown that continuous implant migration within the first two years postoperatively is predictive of later loosening and failure in the hip and knee, with aseptic loosening of implant components a guaranteed cause for revision in the reverse shoulder. By identifying implants with a tendency to migrate, they can be eliminated from clinical practice prior to widespread use. The purpose of this study is to, for the first time, evaluate the pattern and magnitude of implant component migration in RTSA using the gold standard imaging technique radiostereometric analysis (RSA).

Controversy continues to exist regarding the choice of a cementless femoral component in a primary total hip arthroplasty. Both proximally coated tapered stems and fully coated cylindrical stems have excellent clinical results. The incidence of both thigh pain and proximal femoral stress shielding and multiple validated outcome measures were evaluated in a prospective randomized clinical trial with a minimum of two year follow-up comparing a proximally coated tapered femoral stem to a fully coated cylindrical femoral stem. A prospective randomized clinical trial (RCT) was performed comparing a cylindrical cobalt chrome fully coated femoral stem (Prodigy, Depuy, Warsaw, IN) to a tapered, titanium, proximally porous coated stem (Synergy, Smith & Nephew,. Memphis, TN) with respect to thigh pain, femoral stress shielding and multiple outcome measures. One hundred and ninety-four patients were enrolled and evaluations were performed pre-operatively, three months, six months and annually. Multiple outcome measures (Harris Hip Score, SF12, WOMAC, Patient Satisfaction Questionnaire, Thigh Pain Questionnaire) were obtained. Sixty-one of these patients were randomized to receive a bone density scan pre-operatively, two weeks post-operatively, six months and annually. Twelve patients were unavailable for two-year follow-up, leaving one hundred and eighty-two patients evaluated. No significant differences were demonstrated in thigh pain incidence or the multiple outcome measures. Bone density scans demonstrated significantly greater bone density (p< 0.005) in the tapered stem versus the cylindrical stem patients at two-week evaluations from distal femoral reaming. Both stem designs demonstrated statistically significant bone loss in Gruen zones one, six, seven between the two-week and one and two-year evaluations. There were no differences between stem designs although the Prodigy stem demonstrated trends towards greater bone loss in Gruen zones six and seven. This prospective RCT demonstrated no difference in thigh pain incidence and multiple outcome measures between patients receiving a proximally coated tapered versus a fully coated cylindrical femoral component. Both stem designs demonstrated statistically significant proximal femoral bone loss between the post-operative and two-year evaluations; however, there were no differences between stem designs

To compare 24-month patient-reported outcomes after surgical treatment or casting in patients age 60 years of age or older with unstable distal radius fractures (DRF's).

The Wrist and Radius Injury Surgical Trial (WRIST), is the largest randomized, multicenter trial in Hand Surgery, which enrolled 304 adults with isolated, unstable DRF's at 24 institutions. WRIST participants were followed for 24 months- longest follow-up among prospective studies comparing four treatment methods. Patients who agreed to surgical treatment (n=187) were randomized to internal fixation with volar plate (VLPS), external fixation, or percutaneous pinning; patients who preferred conservative management (n=117) received casting. The primary outcome was 24-month Michigan Hand Outcomes Questionnaire (MHQ) Summary score. Secondary outcomes were MHQ Domain scores.

At 24-month assessment, participants' mean MHQ Summary score was 86 (95% CI: 83,88), representing good hand function. Participants reported good return of their Activities of Daily Living (ADLs) with a mean MHQ ADL score of 88 (95% CI: 85,91). Finally, participants were satisfied, with a mean MHQ Satisfaction score of 84 (95% CI: 80,88). There were no significant differences in score by treatment group in any MHQ domain at 24 months. Six weeks after surgery, VLPS participants scored significantly higher than the other three groups on (ADLs) and Satisfaction (both p<0.0001), whereas participants who received external fixation scored significantly lower than the casting and VLPS groups on the same domains. By the 3-month assessment, the gap between VLPS and casting had disappeared but external fixation participants continued to report significantly worse scores. External fixation participants did not report comparable ADL scores to the other three groups until 12 months after surgery.

Participants reported good outcomes 24 months after DRF regardless of treatment. Casting and VLPS are both acceptable treatments for older adults. The decision between the two treatments should be made considering patient goals regarding recovery speed and desire to avoid surgical risks. External fixation should be avoided because of worse outcomes in the year after surgery and the risk of pin site infections.

Introduction and Objectives: In 2000 Bösch published the results of a laterally displaced percutaneous sub-capital osteotomy of the first metatarsal, without medial exostosis resection and without soft tissue surgery. There is no data on the characteristics of the bone consolidation in relation to the level and displacement of the osteotomy. We present data on these variables. Materials and Methods: This is a prospective clinical study of: 30 trans-epiphyseal osteotomies, 30 metaphyseal osteotomies, 30 diaphyseal osteotomies and 10 completely displaced and dislocated osteotomies of the first intermatatarsal space. There was a minimum 1 year clinical and radiological follow-up. All the osteotomies were fixated by means of a 2 mm diameter Kirschner nail. Results: The epiphyseal osteotomies consolidated without any apparent periosteal callus, there was osteolysis and fragment impaction in 19 cases; 1 non-union and 3 delays in consolidation. The metaphyseal osteotomies consolidated with variable degrees of periosteal callus; in 9 cases there was osteolysis and fragment impaction, in 1 case there was non-union but this had consolidated spontaneously after 2 years. Diaphyseal osteotomies consolidated with abundant medullar-periosteal callus; in 5 cases there was fragment impaction. Diaphyseal osteotomies with head dislocation consolidates with abundant medullar-periosteal callus; in 7 cases there was metatarsal shortening (3mm–7mm). Discussion and Conclusions: We found that 97% of the osteotomies healed perfectly in 2–3 months. The type of consolidation and whether there was or not metatarsal shortening depended on the bone tissue at the point of contact of the fragments: Cancellous-cancellous bone (epiphyseal osteotomies), cancellous-cancellous or cancellous-cortical bone (metaphyseal osteotomies, cortical-cortical bone (diaphyseal ostetomies)

Inappropriate use of surgical dressing cause blisters around the surgical wound and increase the incidence of peri-operative wound infection and patients dissatisfaction which influence the outcome of the surgery. It is more so when patients are being treated as a day case procedure. We have not found any study correlating with patient’s satisfaction and surgical dressing. Objective: To evaluate patient’s preference of surgical dressing and analyse which type of dressing is associated with significant morbidity. Design: Prospective, Non randomised, Clinical study. Materials and Methods: Two different dressings Opsite post op or Mepore were applied by a single surgeon on 100 patients (50 each group) undergoing same arthroscopic procedure of the knee under general anesthetic were included in this study. They were followed up to 10 days. An independent nurse practitioner evaluated the complication related to the dressing and assessed the satisfaction with the 5 item short questionnaires at outpatients clinic. Results: Blisters developed in 6% of patients with Mepore dressing (p=0.24) and none with Opsite Post op. 14% Patients with Mepore dressing developed superficial inflammation and this is significantly greater (p< 0.001) than opsite. 86% patients with opsite dressing on were able to take bath and thereby reduce the chance of contamination from the skin flora. 90% patients with opsite rated the dressing as excellent compared to mepore 26%, (p< 0.001). Conclusion: Patients preferred Opsite post op as the dressing of their choice. It is not associated with dressing related morbidity, may improve better post operative wound healing. It may help to prevent superficial wound infection by contamination. After this study, we have changed our policy

Aims: The purpose of this study was to evaluate primary stability and the time of bony þxation of two different designed cementless titanium hip stems. Therefore we designed a prospective clinical study with high precision RSA and close follow up periods (3, 6,12, 24, 52, 104 weeks). Methods: One stem was a Ç straight stem È (BICONTACT, Aesculap AG, Germany) with a rough pure Titanium surface in the upper part for proximal þxation. The second stem (Image, Smith& Nephew, Germany) was anatomically shaped with additional HA coating. 34 IMAGE stems and 20 BICONTACT stems with RSA markers were implanted. Mean age in both groups was 64 years. In September 2002, 28 patients (14 X BICONTACT and 16 X IMAGE) were followed for more than 1 year and 12 patients (6 X BICONTACT and 6 X IMAGE) for more than 2 years. Results: Subsidence was predominantly observed between the postoperative control and the 6 weeks follow up. (IMAGE 0.83mm, BICONTACT 0,60mm) and decreased up to 12 weeks (IMAGE 0.05mm, BICONTACT 0,29mm). After 12 weeks both stems were stabilized (12–24 weeks: IMAGE 0.05mm, BICONTACT 0.06mm; 6 months -1 year: IMAGE 0.05mm, BICONTACT 0.04mm. Between 1 and 2 years subsidence for the IMAGE stem was 0.05mm compared to 0.16mm in the Bicontact group. Overall subsidence of the IMAGE stem during the þrst year was 0.96mm compared to 0.97mm for the BICONTACT stem. Conclusions: Titanium cementless hip stems with a rough proximal titanium surface or HA coating showed a sufþcient primary and mid-term stability. Bony þxation is achieved between 6 and 12 weeks. No statistical differences were found between both stems

Aims

The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures

Aims

Pin-site infection remains a significant problem for patients treated by external fixation. A randomized trial was undertaken to compare the weekly use of alcoholic chlorhexidine (CHX) for pin-site care with an emollient skin preparation in patients with a tibial fracture treated with a circular frame.

Aims

Recent studies of nonoperatively treated displaced midshaft clavicular fractures have shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies have shown superior functional results and higher rates of healing following operative treatment. The aim of this study was to compare the outcome in these patients after nonoperative management with those treated with fixation.

The purpose of this study was to quantify tibial tunnel enlargement at 3-, 6- and 12-months post-anterior cruciate ligament reconstruction (ACLR), and evaluate the magnitude of tunnel widening with use of a Poly (L-lactic Acid) interference screw (PLLA (Bioscrew XtraLok, Conmed, New York)) compared to a Poly (L-lactic Acid) + tricalcium phosphate interference screw (PLLA+TCP (GENESYS Matryx screw comprised of microTCP and 96L/4D PLA, Conmed, New York)).

This was a prospective randomized controlled trial with two parallel groups. Eighty unilateral ACL-deficient participants awaiting ACLR surgery were recruited between 2013 and 2017 from the clinic of a sole fellowship trained orthopaedic surgeon. Patients had to be skeletally mature and less than 45 years old, with no concomitant knee ligament injuries requiring surgery, chondromalacia, or previous history of ipsilateral knee joint pathology, surgery or trauma to the knee.

Participants were randomized intra-operatively into either the PLLA or PLLA+TCP tibial interference screw fixation group. Study time points were pre-, 3-, 6-, and 12-months post ACLR. Participants underwent x-rays with a 25 mm calibration ball, IKDC knee assessment, and completed the ACL-Quality of Life score (ACL-QOL) at each visit.

Measurement (mm) of the most proximal and distal extents as well as the widest point of the tibial tunnel were taken using efilm (IBM Watson Health) and were standardized relative to the calibration ball. A contrast inverter was used to determine clear borders based on contrast between normal and drilled bone. In addition, a subjective evaluation of the tunnel was conducted looking for bowing of the borders of the tunnel or change in tunnel shape, categorizing the tunnel as widened or not widened.

Differences between groups at each time point were evaluated using independent t-tests corrected for multiple comparisons. Tunnel width was also compared as a percentage of actual screw size at 12-months post-operative. Categorical data were compared using Fisher's Exact Test. Forty participants were randomized to each group with mean age (SD) of 29.7 (7.6) and 29.8 (9.1), for PLLA and PLLA+TCP, respectively. There were no differences between groups in age, gender or ACL-QOL.

There were no differences found between groups at any time point in either tunnel width measurements or tunnel width as a percentage of actual screw size. The greatest difference between groups was noted in the measurement of the widest point on lateral x-ray view with a mean difference of 11%. Based on subjective evaluation of tunnel shape, three participants had visible widening in the PLLA group, and two in the PLLA+TCP group (p=NS).

No differences in tunnel widening were identified between ACL reconstruction patients using a PLLA interference screw compared to a PLLA+TCP screw for tibial fixation up to 12-months post-operative.

Total hip arthroplasty surgery may be associated with substantial loss of blood often necessitating blood transfusion. The risks associated with blood transfusions are widely known. Haemostatic drugs have been tried in the past to try and reduce this, and there has been renewed interest in these recently, in particular Aprotinin (Bayer). Aprotinin is a serine protease inhibitor, which has been shown to reduce blood loss in cardiac surgery by up to eighty percent. The aim of our study was to investigate whether or not high dose Aprotinin can reduce blood loss and transfusion rates in patients’ undergoing total hip arthroplasty. This was a randomised double blind controlled clinical trial, where 50 patients were randomised to receive either Aprotinin (2 x 106 KIU followed by an infusion of 5 x 105 KIU/hr), or an equivalent volume of normal saline. Blood loss and transfusion rates were measured as well as the incidence of deep vein thrombosis. There was a significant reduction in total blood loss seen in the Aprotinin group, median 817±350, when compared to the control group, median 1191±386. This translates to a 31% reduction in blood loss. DVT and transfusion rates were not significantly different between the two groups. There was no complications or deaths seen in the Aprotinin group. The use of high dose Aprotinin results in a reduction in blood loss in total hip arthroplasty. It has been proved to reduce blood loss in cardiac surgery, and although papers have shown it can reduce blood loss in orthopaedic surgery, its’ use should not as yet be routine. Further work is required to investigate the possibility of a future role for Aprotinin in orthopaedic surgery, as well as its’ mode of action. Until then more established methods of blood conservation should be used

Introduction: The aim of this study was to compare the clinical, radiological and functional outcome results of the Scorpio PS TKA prosthesis with either a mobile (MB) or fixed bearing (FB) Pe insert. We hypothesized that the MB group would perform better over time in clinical and functional outcome as well as showing a reduction in anterior knee pain occurrence. Methods: In a prospective, randomised, single centre, multi surgeon clinical study, a total of 100 patients were enrolled equally divided between MB and FB groups. A standard surgical protocol was used for implanting the Scorpio knee prosthesis with either an MB or FB insert. Post-op rehabilitation was standardized and unrelated to insert type. Patients were assessed pre-op and after 3–6-12–24 months post-op. RAND-36 and Knee Society Score (KSS), were assessed as well as pain measurement during functional testing (chair rise and stair climb) using Visual Analogue Scale (VAS) scale. X-rays were assessed for implant positioning, migration, radiolucent lines and patella tilt (using a Skyline view in 30–60 and 90 degrees). Results: Both tests groups showed a statistical significant decrease of VAS pain score over time (p < 0.01). No significant differences were seen between both groups at any time point. results did show the MB group to have less pain the first postoperative year in both chair rise test and stair climb test tests. No statistically significant differences were found in total range of motion between the two groups. Repeated measures tests showed a significant improvement over time for both groups for KSS and most RAND 35 subscores. There were no significant differences between groups at any given follow up moment. Within 8 out of 9 RAND 36 subdivisions showed the MB group to score non significantly better the first postoperative year. After one year the differences disappeared. Radiology showed stable implants with no progressive radiolucent lines in all patients. No significant differences in patellar tilting were found. Discussion: Our hypothesis, that the MB prostheses would provide a better ROM and less anterior knee pain, was not confirmed by the results. In our study the MB group showed less decrease in ROM immediately postop. This phenomenon was also seen by Harrington et al. The MB prosthesis regained its ROM after surgery earlier than the FB implants. This difference could potentially be attributed to the implant design and its kinematics. This advantage did not persist and the FB group slowly leveled. In conclusion, our study does not show any clear advantages in terms of function, pain, ROM, general health, radiological evaluation, KSS and RAND 36 of MB compared with FB TKA at a follow-up of 2 years

Aims

The aim of this study was to compare the incidence of anterior knee pain after antegrade tibial nailing using suprapatellar and infrapatellar surgical approaches

Introduction

Tranexamic acid (TXA) is proven to reduce blood loss following total knee arthroplasty (TKA), but there are limited data on the impact of similar dosing regimens in revision TKA that is associated with greater blood loss. The purpose of this multi-center randomized trial was to determine the optimal regimen to maximize the blood-sparing properties of TXA in revision TKA.

The purpose this prospective, randomized clinical trial was to determine if unilateral or bilateral simultaneous total hip arthroplasty procedures resulted in a differing incidence of fat embolization, degree of hemodynamic compromise, levels of hypoxemia or mental status changes. Also, the incidence of fat embolization was compared between the cemented and cementless total hip arthroplasty in the patients with a unilateral- and bilateral simultaneous total hip arthroplasty. One hundred and fifty-six consecutive patients undergoing primary total hip arthroplasty were enrolled prospectively in the study after giving informed consent. The group consisted of fifty patients undergoing bilateral simultaneous total hip arthroplasty and 106 patients undergoing unilateral total hip arthroplasty. One hundred and three hips were cemented and 103 hips were cementless. To determine the hemodynamic changes and to detect the fat and bone marrow embolization, arterial and right atrial blood samples were obtained before implantation (baseline) and at one, three, five and ten minutes after implantation of the acetabular component. Also, arterial and right atrial blood samples were obtained at one, three, five and ten minutes after implantation of the femoral component. And then blood samples were obtained at twenty-four and forty-eight hours after the operation. Arterial blood pressure, right atrial pressure, arterial oxygen tension and carbon-dioxide tension were monitored at corresponding times. The presence of lipid was determined with oil red O fat stain and the presence of cellular contents of bone marrow was determined with Wright-Giemsa stain. The incidence of fat embolism was not statistically different (P=1.000) between the patients with a bilateral total hip arthroplasty (twenty seven patients or 54 per cent) and the patients with a unilateral total hip arthroplasty (fifty-two patients or 49 per cent). In the semiquantitative analysis of fat globules in both groups, there was no tendency to have a higher number of fat globules in the bilateral group than in the unilateral group. Also, the incidence of bone marrow embolization was not statistically different (P=0.800) between the patients with a bilateral total hip arthroplasty (eight patients or 16 per cent) and the patients with a unilateral total hip arthroplasty (fourteen patients or 13 per cent). There was no statistical difference (P=0.800) in the incidence of the presence of fat globule between the cemented total hip (thirty-four patients or 34 per cent) and the cementless total hip arthroplasty (forty-seven patients or 44 per cent). Also, there was no statistical difference (P=0.627) in the incidence of the presence of bone marrow cells between the cemented total hip arthroplasty (thirteen patients or 13 per cent) and the cement-less total hip arthroplasty (twelve patients or 11 per cent). Four patients with positive bone marrow cells had neurological manifestation. All of these four patients developed diffuse encephalopathy with confusion and agitation for about twenty-four hours. The present study confirmed that the incidence of fat and bone marrow embolization is similar in the patients with a bilateral simultaneous-and unilateral total hip arthroplasty as well as in the patients with cemented and cementless total hip arthroplasty. The patients with bone marrow cell emboli had a significantly lower arterial oxygen tension (p=0.022) and oxygen saturation (p=0.017) than the patients without bone marrow cell emboli. On the contrary, the number of fat globules did not affect the perioperative hemodynamic changes. Encephalopathy is related to the biochemical and/or mechanical changes by bone marrow cells

Introduction

The application of artificial intelligence (A.I) using patient reported outcomes (PROs) to predict benefits, risks, benefits and likelihood of improvement following surgery presents a new frontier in shared decision-making. The purpose of this study was to assess the impact of an A.I-enabled decision aid versus patient education alone on decision quality in patients with knee OA considering total knee replacement (TKR). Secondarily we assess impact on shared decision-making, patient satisfaction, functional outcomes, consultation time, TKR rates and treatment concordance.

Introduction: In total hip arthroplasty (THA) polyethylene (PE) wear debris is major cause of osteolysis and aseptic implant loosening. Wear particle volumes must be reduced to increase implant survival. Various ways of crosslinking the molecular chains of PE have been proposed to increase the wear resistance of the bearing material but prospective long-term follow-up studies are scarce. Materials & Methods A crosslinked PE acetabular insert was developed by gamma irradiating in a nitrogen atmosphere at a dose of 3MRad and subsequent annealing at 50° C for 144 hours to promote further crosslinking (“Duration” process). The Duration PE was compared to a conventionally prepared PE insert (irradiated at 3 MRad in air, no annealing) in a series of small punch tests, a hip wear simulator study and in-vivo as part of a randomized double-blind clinical study at three medical centers the PE-insert being the only variable. A total of 127 patients with 133 inserts (67 conventional, 66 Duration) were followed up between three and five years post-operatively. Wear was measured yearly by using a computer-based image analysis system. Radiographic appearance of potentially wear related phenomena such as osteolysis or loosening was assessed by an independent reviewer. Results: Higher load at break during the small punch test confirmed the elevated crosslinking levels of Duration PE against the conventional PE. In the joint simulator Duration PE showed significantly lower volumetric wear rates (Mean SD: 21.7 2.3 mm3/10E6 cycles) than conventional PE (39.7 1.5 mm3/10E6 cycles, p< 0.05). A corresponding and significant level of wear reduction for the Duration PE was identified in-vivo (Duration: 43.7 33.6 mm3/year, conventional: 60.4 42.7 mm3/year, p=0.04). Radiographic analysis at the last follow-up gave evidence of femoral osteolytic lesions in five hips with conventional PE inserts and only one hip with a Duration insert. Conclusions: Acetabular inserts made of crosslinked PE using the Duration process can significantly reduce in-vivo wear rates and the occurrence of potentially wear related osteolytic effects in the long-term follow-up of THA patients. The reduced clinical wear rates corresponded well with the results from the wear simulator measurements. This suggests that a PE with further increased crosslinking which shows even lower wear rates in simulator studies will lead to even lower wear and associated osteolysis in long-term clinical application

The aim of our study was to compare the incidence of post-operative anterior knee discomfort after anterograde tibial nailing by suprapatellar and infrapatellar approaches.

95 subjects presenting with a tibial fracture requiring an intramedullary nail were randomised to treatment using a suprapatellar (SP) or infrapatellar (IP) approach. Anterior knee discomfort was assessed at 4 months, 6 months and 1 year post operatively using the Aberdeen Weightbearing Test-Knee (AWT-K), knee specific patient reported outcome measures and the VAS pain score. The AWT-K is an objective measure which uses weight transmitted through the knee when kneeling as a surrogate for anterior knee discomfort.

53 patients were randomised to an SP approach and 42 to an IP approach. AWT-K results showed a greater mean proportion of weight transmitted through the injured leg compared to the uninjured leg when kneeling in the SP group compared to the IP group at all time points at all follow-up visits. This reached significance at 4 months for all time points except 30 seconds. It also reached significance at 6 months at 0 seconds and 1 year at 60 seconds.

We conclude that the SP approach for anterograde tibial nailing reduces anterior knee discomfort post operatively compared to the IP approach.