Aims. Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Methods. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants. Results. No bias in treatment effect was observed overall for the CI site, or the first five sites, compared with the remaining sites in either trial. An early treatment effect on the OSS was observed for the first quintile of participants recruited to ProFHER only (clinically relevant difference of seven points). Selection bias for age was observed in the ProFHER trial only, with slightly younger patients being recruited into the study. Both trials showed some selection bias for markers of poor prognosis, although these did not appear to change over time. Conclusion. No bias in treatment effects overall were found at the CI or early sites set-up. An early treatment effect was found in one of the two trials, which was likely a chance effect as this did not continue during the study. Selection bias was observed in both RCTs, however this was minimal and did not impact on outcome. Cite this article: Bone Jt Open 2023;4(2):96–103

Aims. Fixation of osteoporotic proximal humerus fractures remains challenging even with state-of-the-art locking plates. Despite the demonstrated biomechanical benefit of screw tip augmentation with bone cement, the clinical findings have remained unclear, potentially as the optimal augmentation combinations are unknown. The aim of this study was to systematically evaluate the biomechanical benefits of the augmentation options in a humeral locking plate using finite element analysis (FEA). Methods. A total of 64 cement augmentation configurations were analyzed using six screws of a locking plate to virtually fix unstable three-part fractures in 24 low-density proximal humerus models under three physiological loading cases (4,608 simulations). The biomechanical benefit of augmentation was evaluated through an established FEA methodology using the average peri-screw bone strain as a validated predictor of cyclic cut-out failure. Results. The biomechanical benefit was already significant with a single cemented screw and increased with the number of augmented screws, but the configuration was highly influential. The best two-screw (mean 23%, SD 3% reduction) and the worst four-screw (mean 22%, SD 5%) combinations performed similarly. The largest benefits were achieved with augmenting screws purchasing into the calcar and having posteriorly located tips. Local bone mineral density was not directly related to the improvement. Conclusion. The number and configuration of cemented screws strongly determined how augmentation can alleviate the predicted risk of cut-out failure. Screws purchasing in the calcar and posterior humeral head regions may be prioritized. Although requiring clinical corroborations, these findings may explain the controversial results of previous clinical studies not controlling the choices of screw augmentation

This study describes the epidemiology and outcome of 637 proximal humeral fractures in 629 elderly (≥ 65 years old) patients. Most were either minimally displaced (n = 278, 44%) or two-part fractures (n = 250, 39%) that predominantly occurred in women (n = 525, 82%) after a simple fall (n = 604, 95%), who lived independently in their own home (n = 560, 88%), and one in ten sustained a concomitant fracture (n = 76, 11.9%). The rate of mortality at one year was 10%, with the only independent predictor of survival being whether the patient lived in their own home (p = 0.025). Many factors associated with the patient’s social independence significantly influenced the age and gender adjusted Constant score one year after the fracture. More than a quarter of the patients had a poor functional outcome, with those patients not living in their own home (p = 0.04), participating in recreational activities (p = 0.01), able to perform their own shopping (p < 0.001), or able to dress themselves (p = 0.02) being at a significantly increased risk of a poor outcome, which was independent of the severity of the fracture (p = 0.001). A poor functional outcome after a proximal humeral fracture is not independently influenced by age in the elderly, and factors associated with social independence are more predictive of outcome. Cite this article: Bone Joint J 2014;96-B:970–7

Objectives. Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck. Methods. The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons. Results. Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. Conclusions. A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management. Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481–489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1

We have previously described the short-term outcome of the use of reverse shoulder arthroplasty in the treatment of acute complex proximal humeral fractures in the elderly. We now report the clinical and radiological outcome of 36 fractures at a mean of 6.6 years (1 to 16). Previously, at a mean follow-up of 6 years (1 to 12) the mean Constant score was 58.5; this was reduced to 53 points with the further follow-up. A total of 23 patients (63%) had radiological evidence of loosening of the glenoid component. Nevertheless, only one patient had aseptic loosening of the baseplate at 12 years’ follow-up. The reduction in the mean Constant score with longer follow-up and the further development of scapular notching is worrying. New developments in design, bearing surfaces and surgical technique, and further follow-up, will determine whether reverse shoulder arthroplasty has a place in the management of complex proximal humeral fractures in the elderly

Aims. Acromial fractures following reverse shoulder arthroplasty (RSA) have a wide range of incidences in reported case series. This study evaluates their incidence following RSA by systematically reviewing the current literature. Materials and Methods. A systematic review using the search terms “reverse shoulder”, “reverse total shoulder”, or “inverted shoulder” was performed using PubMed, Web of Science, and Cochrane databases between 1 January 2010 and 31 March 2018. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used. Studies were included if they reported on RSA outcomes and the incidence rate of acromial and/or scapular spine fractures. The rate of these fractures was evaluated for primary RSA, revision RSA, RSA indications, and RSA implant design. Results. The review included 90 articles out of 686 identified after exclusions. The incidence rate of acromial and/or scapular spine fractures was 2.8% (253/9048 RSAs). The fracture rate was similar for primary and revision RSA (2.8% vs 2.1%; p = 0.4). Acromial fractures were most common after RSA for inflammatory arthritis (10.9%) and massive rotator cuff tears (3.8%). The incidence was lowest in RSA for post-traumatic arthritis (2.1%) and acute proximal humerus fractures (0%). Lateralized glenosphere design had a significantly higher rate of acromial fractures compared with medial glenosphere designs. Conclusion. Based on current English literature, acromial and/or scapular spine fractures occur at a rate of 2.8% after RSA. The incidence is slightly more common after primary compared with revision arthroplasty. Also, higher rates of acromial fractures are reported in RSA performed for inflammatory arthritis and in the lateralized glenoid design. Cite this article: Bone Joint J 2019;101-B:627–634

Objectives. To explore whether orthopaedic surgeons have adopted the Proximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial results routinely into clinical practice. Methods. A questionnaire was piloted with six orthopaedic surgeons using a ‘think aloud’ process. The final questionnaire contained 29 items and was distributed online to surgeon members of the British Orthopaedic Association and British Elbow and Shoulder Society. Descriptive statistics summarised the sample characteristics and fracture treatment of respondents overall, and grouped them by whether they changed practice based on PROFHER trial findings. Free-text responses were analysed qualitatively for emerging themes using Framework Analysis principles. Results. There were complete responses from 265 orthopaedic and trauma surgeons who treat patients with proximal humeral fractures. Around half (137) had changed practice to various extents because of PROFHER, by operating on fewer PROFHER-eligible fractures. A third (43) of the 128 respondents who had not changed practice were already managing patients non-operatively. Those who changed practice were more likely to be younger, work in a trauma unit rather than a major trauma centre, be specialist shoulder surgeons and treat fewer PROFHER-eligible fractures surgically. This group gave higher scores when assessing validity and applicability of PROFHER. In contrast, a quarter of the non-changers were critical, sometimes emphatically, of PROFHER. The strongest theme that emerged overall was the endorsement of evidence-based practice. Conclusion. PROFHER has had an impact on surgeons’ clinical practice, both through changing it, and through underpinning existing non-operative practice. Although some respondents expressed reservations about the trial, evidence from such trials was found to be the most important influence on surgeons’ decisions to change practice. Cite this article: L. Jefferson, S. Brealey, H. Handoll, A. Keding, L. Kottam, I. Sbizzera, A. Rangan. Impact of the PROFHER trial findings on surgeons’ clinical practice: An online questionnaire survey. Bone Joint Res 2017;6:590–599. DOI: 10.1302/2046-3758.610.BJR-2017-0170

The February 2015 Shoulder & Elbow Roundup. 360 . looks at: Proximal Humerus fractures a comprehensive review, Predicting complications in shoulder ORIF, The Coronoid Revisited, Remplissage and bankart repair for Hill-Sach’s lesions, Diabetes and elbow arthroplasty, Salvage surgery for failed bankart repair, Sternoclavicular Joint Reconstruction, Steroids effective in the short-term for tennis elbow

The October 2014 Shoulder & Elbow Roundup. 360 . looks at: PRP is not effective in tennis elbow; eccentric physiotherapy effective in subacromial pain; dexamethasone in shoulder surgery; arthroscopic remplissage for engaging Hill-Sach’s lesions; a consistent approach to subacromial impingement; delay in fixation of proximal humeral fractures detrimental to outcomes

Aims. The reasons for failure of a hemirthroplasty (HA) when used to treat a proximal humeral fracture include displaced or necrotic tuberosities, insufficient metaphyseal bone-stock, and rotator cuff tears. Reverse total shoulder arthroplasty (rTSA) is often the only remaining form of treatment in these patients. The aim of this study was to evaluate the clinical outcome after conversions from a failed HA to rTSA. Material and Methods. A total of 35 patients, in whom a HA, as treatment for a fracture of the proximal humerus, had failed, underwent conversion to a rTSA. A total of 28 were available for follow-up at a mean of 61 months (37 to 91), having been initially reviewed at a mean of 20 months (12 to 36) postoperatively. Having a convertible design, the humeral stem could be preserved in nine patients. The stem was removed in the other 19 patients and a conventional rTSA was implanted. At final follow-up, patients were assessed using the American Shoulder and Elbow Surgeons (ASES) score, the Constant Score, and plain radiographs. Results. At final follow-up, the mean ASES was 59 (25 to 97) and the mean adjusted Constant Score was 63% (23% to 109%). Both improved significantly (p < 0.001). The mean forward flexion was 104° (50° to 155°) and mean abduction was 98° (60° to 140°). Nine patients (32%) had a complication; two had an infection and instability, respectively; three had a scapular fracture; and one patient each had delayed wound healing and symptomatic loosening. If implants could be converted to a rTSA without removal of the stem, the operating time was shorter (82 minutes versus 102 minutes; p = 0.018). Conclusion. After failure of a HA in the treatment of a proximal humeral fracture, conversion to a rTSA may achieve pain relief and improved shoulder function. The complication rate is considerable. Cite this article: Bone Joint J 2018;100-B:761–6

The October 2014 Trauma Roundup. 360 . looks at: proximal humeral fractures in children; quadrilateral surface plates in transverse acetabular fractures; sleep deprivation and poor outcomes in trauma; bipolar hemiarthroplasty; skeletal traction; forefoot fractures; telemedicine in trauma; ketamine infusion for orthopaedic injuries; and improved functional outcomes seen with trauma networks

Aims

The outcomes following nonoperative management of minimally displaced greater tuberosity (GT) fractures, and the factors which influence patient experience, remain poorly defined. We assessed the early patient-derived outcomes following these injuries and examined the effect of a range of demographic- and injury-related variables on these outcomes.

The February 2014 Trauma Roundup. 360 . looks at: predicting nonunion; compartment Syndrome; octogenarian RTCs; does HIV status affect decision making in open tibial fractures?; flap timing and related complications; proximal humeral fractures under the spotlight; restoration of hip architecture with bipolar hemiarthroplasty in the elderly; and short versus long cephalomedullary nails for the treatment of intertrochanteric hip fractures in patients over 65 years

Objectives . A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. Methods . These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. Results. All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. Conclusion . In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335–40

Aims

The aim of this systematic review and meta-analysis was to gather epidemiological information on selected musculoskeletal injuries and to provide pooled injury-specific incidence rates.

We evaluated the impact of stereo-visualisation of three-dimensional volume-rendering CT datasets on the inter- and intraobserver reliability assessed by kappa values on the AO/OTA and Neer classifications in the assessment of proximal humeral fractures. Four independent observers classified 40 fractures according to the AO/OTA and Neer classifications using plain radiographs, two-dimensional CT scans and with stereo-visualised three-dimensional volume-rendering reconstructions. Both classification systems showed moderate interobserver reliability with plain radiographs and two-dimensional CT scans. Three-dimensional volume-rendered CT scans improved the interobserver reliability of both systems to good. Intraobserver reliability was moderate for both classifications when assessed by plain radiographs. Stereo visualisation of three-dimensional volume rendering improved intraobserver reliability to good for the AO/OTA method and to excellent for the Neer classification. These data support our opinion that stereo visualisation of three-dimensional volume-rendering datasets is of value when analysing and classifying complex fractures of the proximal humerus