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 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

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

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