Meniscal Transplant surgery or Optimised Rehabilitation full randomised trial (MeTeOR2): a study protocol.

INTRODUCTION: Pain and disability after meniscectomy can be a substantial lifelong problem. There are few treatment options, especially for young people. Non-surgical management (rehabilitation) is an option but increasingly surgeons are performing meniscal allograft transplants (MATs) for these individuals. However, this is still an uncommon procedure, and availability and usage of MAT vary widely both in the UK and internationally. It is not known which treatment option is the most effective and cost-effective. METHODS AND ANALYSIS: The Meniscal Transplant surgery or Optimised Rehabilitation trial is an international, multicentre, randomised controlled trial. The aim is to compare the clinical and cost effectiveness of MAT versus an optimised package of individualised, progressive, rehabilitation that we have called personalised knee therapy (PKT).Participants will be recruited from sites across the UK, Australia, Canada and Belgium. The planned 144 participants provide at least 90% power to detect a 10-point difference in the Knee injury and Osteoarthritis Outcome Score (KOOS4) at 24-months post randomisation (primary outcome). A prospectively planned economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including health utility, occupational status, sports participation, mental well-being, further treatment, and adverse events will be collected at 3, 6, 12, 18, and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: The trial was approved by the London-Bloomsbury Research Ethics Committee on 19 August 2022 (22/LO/0327) and Northern Sydney Local Health District Human Research Ethics Committee, NSW, Australia on the 13 March 2023 (2022/ETH01890).Trial results will be disseminated via peer-reviewed publications, presentations at international conferences, in lay summaries and using social media as appropriate.This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. TRIAL REGISTRATION NUMBER: ISRCTN87336549.

Burden of Disease and Treatment Patterns Amongst Patients With Vitiligo: Findings From a National, Longitudinal Retrospective Study in the United Kingdom.

This retrospective study, using UK Clinical Practice Research Datalink and Hospital Episode Statistics databases, analysed 17,239 incident patients with vitiligo. Mean incidence of vitiligo was 0.16 (2010-2021) per 1000 person-years (range: 0.10 [2010-COVID] to 0.19 [2013/2018]); prevalence increased from 0.21% (2010) to 0.38% (2021). The most common comorbidities recorded after vitiligo diagnosis were diabetes (19.4%), eczema (8.9%), thyroid disease (7.5%), and rheumatoid arthritis (6.9%). Mental health diagnoses recorded at any time were most commonly depression and/or anxiety (24.6%), depression (18.5%), anxiety (16.0%), and sleep disturbance (12.7%); recorded after vitiligo diagnosis in 6.4%, 4.4%, 5.5%, and 3.9%, respectively. Mental health comorbidities were more common among White patients (eg, depression and/or anxiety, 29.0%) than Black (18.8%), Asian (16.1%), and other ethnicities (21.4%). In adolescents, depression and/or anxiety was most commonly diagnosed after vitiligo diagnosis (7.4% vs before, 1.8%). Healthcare resources were used most frequently in the first year after vitiligo diagnosis (incident cohort), typically dermatology-related outpatient appointments (101.9/100 person-years) and general practitioner consultations (97.9/100 person-years). In the year after diagnosis, 60.8% of incident patients did not receive vitiligo-related treatments (ie, topical corticosteroids, topical calcineurin inhibitors, oral corticosteroids, phototherapy), increasing to 82.0% the next year; median (95% CI) time from diagnosis to first treatment was 34.0 (31.6-36.4) months. Antidepressants and/or anxiolytics were recorded for 16.7% of incident patients in the year after diagnosis. In 2019, 85.0% of prevalent patients did not receive vitiligo-related treatments; 16.6% had a record of antidepressant and/or anxiolytic treatments. Most patients were not on vitiligo-related treatments within a year of diagnosis, with time to first treatment >2 years, suggesting that vitiligo may be dismissed as unimportant and not treated early, in part due to limited effectiveness of available treatments. New effective treatments, early initiation, and psychological intervention and support are needed to reduce vitiligo burden on patients.

Estimating health related quality of life effects in vitiligo. Mapping EQ-5D-5 L utilities from vitiligo specific scales: VNS, VitiQoL and re-pigmentation measures using data from the HI-Light trial.

BACKGROUND: Vitiligo is reported to affect 2% of the world's population and has a significant impact on health related quality of life (HRQoL). The relationship between HRQoL and clinical outcomes used in vitiligo require further examination. Mapping condition specific measures of HRQoL: vitiligo specific quality of life instrument (VitiQoL), vitiligo noticeability scale (VNS) and vitiligo re-pigmentation scores (RPS) to the EQ-5D have not yet been reported. METHODS: Data collected from a randomised clinical trial (HI-Light) in vitiligo was used to develop mapping algorithms for the EQ-5D-5 L and the relationship between HRQoL, clinical outcomes and EQ-5D were investigated. Two EQ-5D-5 L value sets (Van Hout and Alava) using linear and non-linear models were considered. Logistic regression models were used to model the probability of vitiligo noticeability (VNS) in terms of RPS, EQ-5D and VitiQoL scores. RESULTS: Mapping from RPS appeared to perform better followed by VNS for the Alava crosswalks using polynomial models: Mean observed vs. predicted utilities of 0.9008 (0.005) vs. 0.8984 (0.0004) were observed for RPS. For VNS, mean observed vs. predicted utilities of 0.9008 (0.005) vs. 0.8939 (0.0003) were observed. For VitiQoL, mean observed vs. predicted utilities of 0.9008 (0.005) vs. 0.8912 (0.0002) were observed. For patients with the least re-pigmentation (RPS < 25%), a Total VitiQoL score of about 20 points gives around an 18% chance of vitiligo being no longer or a lot less noticeable. CONCLUSION: The algorithm based on RPS followed by VNS performed best. The relationship between effects from vitiligo specific HRQoL instruments and clinical RPS was established allowing for plausible clinically relevant differences to be identified, although further work is required in this area.

Influence of the Ground Electrode on the Dynamics of Electrowetting.

The ability to manipulate a liquid meniscus using electrowetting has many applications. In any electrowetting design, at least two electrodes are required: one forms the field to change the contact angle and the other functions as a ground electrode. The contribution of the ground electrode (GE) to the dynamics of electrowetting has not yet been thoroughly investigated. In this paper, we discovered that with a bare ground electrode, the contact angle of a sessile drop increases instead of decreases when a direct current (DC) voltage varying from zero to the threshold voltage is applied. This phenomenon is opposite to what occurs when the GE is coated with a dielectric, where the contact-angle change follows the Lippmann-Young equation above the threshold voltage of electrowetting. However, this behaviour is not observed with either a dielectric-coated electrode using direct current (DC) or a bare ground electrode using alternating current (AC) voltage electrowetting. This study explains this phenomenon with finite element simulation and theory. From previous research work, the ground electrode configuration is inconsistent. In some studies, the ground electrode is exposed to water; in other studies, the ground electrode is covered with dielectric. This study identified that an exposed ground electrode is not required in electrowetting. Moreover, this research work suggests that for applications where precise control of the contact angle is paramount, a dielectric-coated ground electrode should be used since it prevents the increase in the contact angle when increasing the applied potential from zero to the threshold voltage. This study also identified that contact angle hysteresis is lower with a Cytop-coated ground electrode and DC voltage than with a bare ground electrode using AC or DC voltages.

Comparative efficacy of self-administered dentifrices for the management of dentine hypersensitivity - A systematic review and network meta-analysis.

OBJECTIVES: This systematic review with network meta-analysis synthesises available randomised controlled trials evidence concerning efficacy of self-administered dentifrices for management of dentine hypersensitivity (DH) pain. STUDY SELECTION: Following systematic review registration (CRD42019154064), three data bases (MEDLINE, Embase, CENTRAL) were searched to December 2022 for parallel randomised controlled trials conducted in adults diagnosed with DH, using at least two recognised stimuli, assessing the short-term efficacy of home-use dentifrice treatment in reducing pain. Thirty-two studies and 4,638 participants were included. A Network meta-analysis (NMA) approach was used to compare relative effectiveness between interventions. CONCLUSIONS: Twice daily application of self-applied dentifrice containing formulations of stannous, potassium +/- stannous, or arginine can be recommended for the reduction of dentine hypersensitivity pain. There is a need for standardised methodology guideline development to improve the conduct, analysis and reporting of DH clinical studies. CLINICAL RELEVANCE: This is the first comprehensive NMA to be performed, that follows guidelines for conduct of DH trials to determine the efficacy of self-applied dentifrices for the management of dentine hypersensitivity. Indirect comparisons can be made between formulations that have not been compared to one another in randomised controlled trials.

Economic Impact of Cancer Diagnosis on Employment, Wages and Intent to Return to Work.

To assess the work hours and income of patients who have been diagnosed with cancer, treatable with curative intent. The study evaluated the impact of lost wages on patients and their families in the population that is served by Bayhealth Medical Center. METHODS: This study was conducted between 2016 and 2020. The curative cancer focus included breast, lung, prostate, colorectal, testicular, uterine, cervical, bladder, esophageal, head and neck, and stomach. Patients were identified on their survivorship visit with Medical Oncology or Radiation Oncology. Two surveys were used to collect information specific to employment status, leave of absence/change in hours, and monthly income. RESULTS: Survey one had 142 participants. Survey two had 134 participants. In survey one, 99.3% of participants reported being employed at least half time at the time of diagnosis. On the Survivorship visit, 95% reported being currently employed at least half time. Only 87% were employed in the same job and title. When reporting income, 64% of participants had the same income, and 25.4% reported a reduction in income since being diagnosed and completing cancer treatment. In survey two, completed one-year post-survivorship visit, 83.6% of participants reported being employed at least half time. Of those, 76.9% were working for the same employer as they were at time of diagnosis. To that end, 26.1% of participants reported their income as lower than it was at time of diagnosis. CONCLUSION: A cancer diagnosis with treatment can and does have an impact on a person's ability to remain employed at least half time and sustain the same level of income.

Evaluating Characteristics in Lung Cancer Screening Program Participants and Non-Small Cell Lung Cancer (NSCLC) Patient Populations.

Objective: To assess and compare specific characteristics and identify any differences, gaps, and/or disparities among two population groups; Bayhealth Lung screening program participants and newly diagnosed non-small cell lung cancer patients. Methods: This study was conducted with 2019 data from the American College of Radiology (ACR) registry, 1st time Low Dose CT screenings (Group 1) and the Bayhealth Cancer registry, newly diagnosed non-small cell lung cancer patients (Group 2). Results: Group 1 has 615 participants and Group 2 has 140 participants. The groups are separated based upon who is a first-time participant in the Bayhealth Lung Screening program in 2019 compared to patients who were newly diagnosed with Non-small Cell Lung Cancer at Bayhealth Medical Center-Cancer Center in 2019. Groups 1 and 2 had a statistical difference in the number of packs per year of cigarettes smoked. In group 2 there is no association between smoking status and clinical stage of diagnosis. There is however an association between smoking experience and pathological stage. Conclusion: Smoking continues to be the main contributing factor in patients diagnosed with non-small cell lung cancer. In addition to prevention efforts, early detection through Lung Cancer screenings is vital to identify early stage cancer.

Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs.

BACKGROUND: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. METHODS: Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. RESULTS: The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. CONCLUSIONS: The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.

Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial.

BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

A pilot study to evaluate the impact of digital imaging on the delivery of oral hygiene instruction.

AIMS: To determine whether personalised Oral Hygiene Advice (OHA) using an intra-oral-camera (IOC) combined with standard OHA as provided in general dental practice reduces plaque levels after 4 weeks more than the provision of standard OHA. MATERIALS AND METHODS: 22 healthy adult participants diagnosed with gingivitis took part in this pilot parallel-designed, randomised, examiner-blind, 2x-treatment, study regarding their home-care oral hygiene habits and attitudes to oral health. An IOC-image was taken and plaque, gingival and bleeding scores were recorded. Test group participants received standard OHA with IOC-images to indicate areas for improvement, control group participants received standard OHA. Questionnaires and plaque, gingival and bleeding scores were repeated after 4 weeks. Plaque was scored from the IOC-images and scores compared to clinical plaque scores. RESULTS: Lifestyle habits, attitudes to oral health, plaque (0.63vs0.61, control vs test) and bleeding scores (1.17vs0.96, control vs test) were similar at baseline. After 4-weeks, plaque scores improved more in test as compared to control group (39.4vs20.6%, p<0.05, while gingival and bleeding scores approached significance. There was no difference in lifestyle habits between groups, but the test group reported significantly greater confidence in adhering to their bespoke oral health plan. Agreement between the clinical and IOC plaque scores was good. CONCLUSIONS: Use of IOC further personalises the prevailing standard of oral hygiene advice and generates great patient engagement with pictorial reports to facilitate a more in-depth patient explanation of their gingival health, resulting in significant plaque reduction and improved gingival health compared to the standard OHA alone.

Randomised controlled trial demonstrating the impact of behaviour change intervention provided by dental professionals to improve gingival health.

AIMS: To determine impact of oral hygiene behaviour change intervention compared to the prevailing standard of oral hygiene advice provided in general dental practice, on bleeding on probing (BOP) in gingivitis patients, over 3-months. The effect of providing power-brushes was also evaluated. MATERIALS AND METHODS: NHS dental practices were cluster-randomised to intervention or control (2:1). Dentists at intervention sites received behaviour modification training. Participants were stratified to high (≥20% BOP) or low (<20% BOP) presence of gingivitis and a subset assigned a power-brush. BOP and plaque scores were assessed at baseline and 3-months. RESULTS: A total of 538 participants (369:169; intervention: control) completed the study. BOP reduced in both gingivitis groups with significantly greater reduction in intervention compared to control group (BOP:38% vs 19%, p = 0.0236); Borderline significance favouring the intervention was demonstrated for the low gingivitis group (BOP:37% vs 15%, p = 0.0523). A highly significant reduction in BOP (intervention vs control) was demonstrated for volunteers who swapped from manual to power-brush (44% vs 37%, p = 0.0039). Plaque score improved more in control than intervention group (Plaque:37% vs 44%, p = 0.00215). CONCLUSIONS: Behaviour change techniques were readily mastered by the dental professional researchers. The introduction of an oral hygiene behaviour change intervention significantly reduced gingivitis in volunteer patients compared to control at 3 months. Swapping to a power-brush significantly favoured BOP reduction compared to manual brush continuation although plaque reduction did not follow expectation in comparison to BOP scores. Behaviour change techniques should routinely be considered in patient care. CLINICAL SIGNIFICANCE: Plaque-induced gingivitis is highly prevalent in the UK despite being preventable with good oral hygiene. Its continuum, periodontitis, negative impacts quality of life. This study suggests oral hygiene behavioural interventions (GPS) significantly reduce gingivitis and that GPS introduction will improve oral health and may improve quality of life.

Protocol for A randomised feasibility trial comparing fluoride interventions to prevent dental decay in older people in care homes (FInCH trial).

BACKGROUND: The number and proportion of older people globally is growing faster than that of any other age group. At the same time the number of people retaining some of their own teeth is rising. There significant differences between those living in care and their community dwelling peers, with evidence showing those in care having fewer teeth and significantly higher levels of dental decay. There are numerous Cochrane reviews linking the use of fluoride to a reduction in dental decay, however, the majority of research on effectiveness has been conducted on children and consequently, children and adolescents tend to be the main recipients of fluoride interventions. There are to date no studies comparing the effectiveness of fluoride interventions in older people in care homes in the UK. However, prior to developing an appropriate protocol for full-scale trial comparing clinical effectiveness of fluoride interventions, there are a number of trial feasibility and statistical parameters that need to be clarified. METHODS: This trial is a single centre, multi-site randomised controlled assessor blind parallel group (three groups) trial, with the primary objective of establishing the feasibility, practicability and compliance of fluoride interventions to prevent dental decay in care homes. Secondary and tertiary objectives will aim to explore the acceptability of the interventions from resident, care home and dental services perspectives, and estimate the efficacy of the three different fluoride treatments. DISCUSSION: This feasibility trial will produce new knowledge and add value to a landscape that is under researched. Although the efficacy of fluoride interventions is proven, the feasibility of dental research and prevention in this vulnerable group and in the complex care home setting is novel. This work will not only add to our understanding of the interface of dental care and social care but will also contribute to our broader understanding on undertaking research in care home settings. Dental care for older people has been a longstanding issue, and the events of this past year has shone a light on the vulnerabilities of those residing in care homes and so this research is landing at a pivotal time. Trial registration EudraCT Registration 2017-002248-34. Registered 20th February 2018 https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-002248-34 .

A Novel Hexagonal Beam Steering Electrowetting Device for Solar Energy Concentration.

Traditional tracking devices for solar energy applications have several disadvantages, such as bulky mechanical structure, large wind loads, and ease of misalignment. This study aims to design a flat, thin, and adaptive beam steering device to eliminate these drawbacks. A proof of concept device was fabricated to demonstrate this design. The novelty of the proof of concept device is the hexagonal structure of the electrowetting cell design. The hexagonal cell was dosed with two immiscible liquids with different refractive indices. The hypothesis of this design is that by deforming the liquid shape with the application of voltage, light can be steered and concentrated for solar energy applications. A maximum contact angle change of 44° was observed with the application of 26 V to one of the electrodes of the hexagonal cell. The device demonstrated a 4.5° change of laser beam path with only a 0.2 refractive index difference of the liquids. The 3D simulation model developed in this study shows that a tilted and flat interface can be achieved using higher dielectric constant dielectric materials. The device can facilitate the planer steering and concentration of sunlight for rooftop applications without moving mechanical parts.

Evaluation of Circulating Tumor DNA for Methylated BCAT1 and IKZF1 to Detect Recurrence of Stage II/Stage III Colorectal Cancer (CRC).

BACKGROUND: Most recurrences of early-stage colorectal cancer detected with current surveillance measures are widespread and incurable. Circulating tumor DNA (ctDNA) may facilitate earlier diagnosis of recurrent colorectal cancer and improve cancer-related outcomes. METHODS: Plasma from patients undergoing standard surveillance after definitive treatment for stage II/III colorectal cancer was assayed with COLVERA and carcinoembryonic antigen (CEA) at a single time point. Results were correlated with radiographic imaging. Assay performance, including sensitivity and specificity for recurrence, were compared. Impact of potentially confounding variables was also explored. RESULTS: 322 patients were included in the final analysis, and 27 recurrences were documented over a median follow-up period of 15 months. Sensitivity for recurrence was 63% [confidence interval (CI), 42.4-80.6] and 48% (CI, 28.7-68.1) for COLVERA and CEA (≥5 ng/mL), respectively (P = 0.046), while specificity was 91.5% (CI, 87.7-94.4) and 96.3% (CI, 93.4-98.1), respectively (P = 0.016). Smoking and age were independent predictors of CEA but not COLVERA positivity. CONCLUSIONS: COLVERA was more sensitive but less specific than CEA in detecting recurrent colorectal cancer. Short median follow-up may have been responsible for apparent false positives in COLVERA. Studies with serial sampling and longer follow-up are needed to assess whether earlier detection of colorectal cancer recurrence translates into clinical benefit. IMPACT: This prospective study showed that COLVERA (a two-gene ctDNA assay) was more sensitive for detection of recurrence in a cohort of patients undergoing surveillance after definitive therapy for stages II and III colorectal cancer.

Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS).

INTRODUCTION: Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials. METHODS AND ANALYSIS: Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media. TRIAL REGISTRATION NUMBER: ISRCTN17825590.