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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.

To show that the treatment of buckle fractures of the distal radius in children in a soft bandage is an effective and safe method of treatment, a randomized prospective trial was undertaken. Patients entered the trial after diagnosis in the accident and emergency department. Allocation to either plaster cast or bandage was random. Bandage patients were seen each week. Plaster cast patients were seen at 4 weeks. Measurements were taken at all visits. Patient questionnaires were completed at the end of treatment. Thirty-nine patients completed the study. Eighteen were allocated to bandage, 21 to plaster cast. Those in bandage showed an excellent range of movement by the first week. Results were highly positive for treatment in bandage, with no reported adverse effects and a highly desirable result for the patient. The authors would suggest a change in treatment policy for such fractures.

Informed consent is an important aspect in patient care. Failings in this area may result in patient dissatisfaction or litigation. The aim of this project was to assess our practice in consenting and institute changes to maintain best practice. A consecutive series of 140 patients undergoing elective and trauma procedures were randomly identified over a nine-month period. The consent forms were reviewed and the following information collected: patient/ consenter details, procedure, legibility, if copy was offered/ given to patient and adequacy of procedure-specific complications listed (scored 0-3). The issues identified included: 25% of consents were not fully legible particularly in the complications section. 62% were noted to have inadequate complications listed (score 0 [>5 risks missing]) when compared to an accepted standard. None of the consent form copies were offered or given to the patients. Focused teaching to juniors as well as procedure-specific complication stickers were implemented to improve the documentation of complications. Following several improvement cycles all consents (100%) were fully legible and had the adequate procedure-specific labels with all complications listed. There was an increase to 38% of consent forms offered to patients. We have asked surgeons in the department to comment on which consent method they prefer and all consenters felt that the procedure-specific labels where easier to read and understand. Departmental education as well as introduction of simple procedure-specific complication stickers has resulted in significant improvements in practice.

Purpose: Traumatic anterior dislocation of the shoulder is a common occurrence increasingly being treated arthroscopically. This study aims to determine the outcome of arthroscopic anterior stabilization using bioknotless anchors and analyze the motion in a subset of these patients. Materials and Methods: The outcome of 20 patients who underwent arthroscopic anterior stabilization using the bioknotless system was studied (average follow-up 26 months). Four of these patients underwent motion analysis of their shoulder pre- and post-operatively. Results: 15% were dissatisfied following surgery and the recurrence of instability was also 15%. Those who were dissatisfied or suffered recurrent symptoms had statistically significant lower constant scores at the final follow up. Pre-operative motion analysis showed a disordered rhythm of shoulder rotation which was corrected following surgery with minimal loss of range of motion. Conclusions: Our success rate was comparable to similar arthroscopic techniques and results published in the literature. Patient satisfaction depended more on return to usual activities than recurrence of symptoms. There was very little reduction in range of movement following surgery and the rhythm of shoulder motion, particularly external rotation in abduction was improved. Level of Evidence: Four retrospective series.