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New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590.Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups.In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears.Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Background The aim of this scoping review is to assess the current evidence regarding periprosthetic shoulder infection to inform development of evidence and consensus-based guidelines. Methods A search of Medline, Embase and PubMed was performed; two authors screened the results independently for inclusion. Results Totally 88 studies were included. Incidence of periprosthetic shoulder infection ranged from 0.7% to 7%. The most common organisms to cause periprosthetic shoulder infection were Propionibacterium acnes, Staphylococcus aureus, Staphylococcus epidermidis and coagulase-negative Staphylococcus. Male gender and younger age are the most reported risk factors. Erythrocyte sedimentation rate, C-reactive protein and serum/synovial biomarkers had limited diagnostic accuracy. Thirty-nine studies reported the outcome of surgical management of periprosthetic shoulder infection. Eradication rates vary from 54% to 100% for debridement procedures; 66–100% for permanent spacers; 50–100% following single-stage revision; 60–100% following two-stage revision; and 66–100% following resection arthroplasty. Conclusion There is wide heterogeneity in study designs and outcomes of studies are often contradictory and due to issues with methodology and small sample sizes the optimal pathways for diagnosis and management cannot be determined from this review. Future research should be based on larger cohorts and randomised trials where feasible to provide more valid research for guiding future treatment of periprosthetic shoulder infection.

Bilateral septic arthritis of the shoulder is uncommon in the immunocompetent patient with no previous risk factors for joint infection, and is thus easily missed. Septic arthritis is associated with significant rates of morbidity and mortality. Early diagnosis and management is the key to a favourable outcome; septic arthritis should be considered as a differential diagnosis in the unwell patient presenting with shoulder pain and reduced range of joint movement. We present a case of a 47-year-old previously fit and well man with bilateral shoulder septic arthritis. We will also review the current literature on management and long-term outcomes of patients with septic arthritis of the glenohumeral joint.

Background Vertebrobasilar stroke associated with the anterior approach to the cervical spine is rare and has not been reported in cervical disc arthroplasty surgery. We report the case of a 60-year-old patient who underwent cervical disc arthroplasty at C4-5, C5-6 and C6-7. Postoperatively, due to symptoms and signs of a cerebellar stroke, magnetic resonance imaging of the brain was obtained confirming this diagnosis. Despite thorough investigation no specific identifiable cause for the stroke has been identified. We hypothesis an unrecognised period of intraoperative hypotension may have caused a temporary reduction in vertebrobasilar blood flow. Methods A retrospective review of the patient9s case notes and a focused review of literature has been performed. Results Now two years postoperatively the patient has regained full power but has residual problems with balance. She has neuralgic pain down the right side of her body which following investigation is believed to result from the stroke. Conclusions / Level of Evidence Surgeons should be aware vertebrobasilar stroke is a possible rare perioperative complication associated with anterior cervical decompression and disc arthroplasty. Level V.

Objective To compare the clinical effectiveness of intravenous paracetamol with intravenous morphine in patients with moderate to severe traumatic limb pain. Methods This randomised, double-blind pilot study was conducted in an urban UK emergency department. Patients between 16 and 65 years old with isolated limb trauma and in moderate to severe pain (pain score of 7 or more) received either 1 g intravenous paracetamol or 10 mg intravenous morphine sulphate over 15 min. The primary outcome measure was pain score measured on a visual analogue scale at 0, 5, 15, 30 and 60 min after commencing drug administration. The requirement for rescue analgesia and the frequency of adverse reactions were also recorded. Results 55 patients were recruited over 10 months. There was no significant difference in analgesic effect between the paracetamol and morphine groups at any time interval. There was no significant difference in the rescue analgesia administered, but there were significantly more adverse reactions in the morphine group. Conclusion Intravenous paracetamol appears to provide a level of analgesia comparable to intravenous morphine in isolated limb trauma. Further larger studies are required.

Background Tennis elbow is a common condition that usually responds to conservative measures. In refractory cases, surgical intervention is indicated. A plethora of surgical techniques have been described. We report the mid- to long-term outcomes of the Boyd–McLeod procedure for refractory tennis elbow. Methods A retrospective analysis and current review of patients that had undergone the Boyd–McLeod procedure over a 12-year period was undertaken. Demographics, time to discharge, length of follow-up and outcome scores were collected. Results Seventy patients underwent surgery. Mean time to discharge was 15.35 weeks, with 88% successful outcomes. Fifty-four patients were available for current follow-up at mean of 5.52 years (range 1.17 years to 11.49 years). Range of motion in all patients was unchanged. There were no revision procedures. Mean (SD) Mayo Elbow Performance Score was 90.85 (13.11), with 75.5% returning a good or excellent score and 24.5% a fair outcome. The mean (SD) Oxford Elbow Score was 44.04 (6.92); mean (SD) pain score was 89.5 (17.58); mean (SD) function score was 95.34 (9.59) and mean (SD) socio-psychological score was 91.50 (17.01). Overall, 83% of patients had an Oxford Elbow Score of 43 or greater, suggesting excellent outcome. Conclusions We show that the Boyd–McLeod procedure is an excellent option over both the short- and long-term for refractory tennis elbow.

The health secretary announced in July plans to launch a NHS Leadership Academy. This article explains what progress has been made in setting up the body and enabling it to support nurses and other front line staff to develop the leadership skills needed to transform the NHS into a genuinely patient-centred service, one in which different services work together to provide integrated care.

Much speculation has taken place over exactly how the proposed changes to the NHS, advocated in the White Paper Working for Patients (DoH, 1989), will be implemented. This chapter steps back from the detailed debate to take a strategic look at the White Paper proposals in the context of basic objectives and the range of available methods of financing and organising health services. These are described in Section 2 and used in Section 3 to classify the schemes advocated by various interest groups prior to the publication of the White Paper. Section 4 discusses the criteria by which the success or failure of reform proposals might be judged. In Section 5 these criteria are used to assess three of the major changes proposed in the White Paper.

This paper describes the evaluation of investment options in nurse human capital and examines how managers can identify the costs and benefits of alternative arrangements. This study followed a request from four health districts on Humberside (East Yorkshire, Grimsby, Hull and Scunthorpe) where managers wished, following proposals from Yorkshire RHA, to make more effective use of resources for nurse training in face of a reduced supply of manpower and pressures to improve the quality of nurse training. The appraisal was carried out in consultation with nurse teachers, managers and the ENB. A framework of objectives and constraints was established within which options could be assessed. These included educational objectives, such as whether an option made it easier to develop post basic courses and to manage manpower constraints such as the retention of basic RGN education in the 3 districts where it was currently carried out. The educational criteria also covered curriculum development, the sharing of resources with universities and polytechnics and career attractions for teaching staff. Options were also assessed in relation to their timing, ease of implementation, flexibility and cost. Four detailed options were assessed and the third, that of establishing a jointly funded and organised college responsible for all nurse training across all four authorities, attained the highest score. This option involved the maintenance of self-contained basic, general nurse training circuits where they exist at present and will permit the development of post basic education. The study identifies significant incentives for cooperation between districts and outline a plan for the creation of a new College. The College would operate on a contractual basis offering courses which the health authorities would take up and pay for on an annual or bi-annual full cost basis. The College would also be able to sell courses to an outside market, for example on occupation health on Humberside, and it would aim to mobilise both NHS and other resources and to compete with outside educational bodies. There has been much discussion of change at the national level in nurse education. This paper examines how changes such as Project 2000 can be managed at the local level to ensure a more effective use of scarce resources. It provides a methodology for similar studies in other nurse labour markets.

As a contribution to the current debate on the future of the NHS, this paper sets out a framework with which proposals for reform can be analysed. Eight different proposals are classified according to their dominant methods of finance and provision of health care. Criteria are then developed by which the proposals can be evaluated, covering issues of efficiency, equity and consumer choice. A checklist of questions is addressed to each option (the detailed results of which are attached to Appendix 1) to determine the mechanisms by which beneficial change is to be brought about, and to identify the evidence available as to whether these mechanisms would be successful. The conclusion is that there is very little hard evidence to support the claims in the various proposals. More experimentation and evaluation is required to produce this before major change is contemplated. What the approach does demonstrate is the difference in ideological perspective behind the proposals and the need for clear statement of objectives by the proposers of reform before its full implications can be assessed.