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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.

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.

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.

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.