Improving the management of open tibia fractures, Malawi.

Objective: To assess the impact of an open fracture intervention bundle on clinical management and patient outcomes of adults in Malawi with open tibia fractures. Methods: We conducted a before-and-after implementation study in Malawi in 2021 and 2022 to assess the impact of an open fracture intervention bundle, including a national education course for clinical officers and management guidelines for open fractures. We recruited 287 patients with open tibia fractures. The primary outcome was a before-and-after comparison of the self-reported short musculoskeletal function assessment score, a measure of patient function. Secondary outcomes included clinical management; and clinician knowledge and implementation evaluation outcomes of 57 health-care providers attending the course. We also constructed multilevel regression models to investigate associations between clinical knowledge, patient function, and implementation evaluation before and after the intervention. Findings: The median patient function score at 1 year was 6.8 (interquartile range, IQR: 1.5 to 14.5) before intervention and 8.4 (IQR: 3.8 to 23.2) after intervention. Compared with baseline scores, we found clinicians' open fracture knowledge scores improved 1 year after the intervention was implemented (mean posterior difference: 1.6, 95% highest density interval: 0.9 to 2.4). However, we found no difference in most aspects of clinicians' open fracture management practice. Conclusion: Despite possible improvement in clinician knowledge and positive evaluation of the intervention implementation, our study showed that there was no overall improvement in clinical management, and weak evidence of worsening patient function 1 year after injury, after implementation of the open fracture intervention bundle.

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.

Surgical versus non-surgical interventions for treating patellar dislocation.

BACKGROUND: Patellar (knee cap) dislocation occurs when the patella disengages completely from the trochlear (femoral) groove. It affects up to 42/100,000 people, and is most prevalent in those aged 20 to 30 years old. It is uncertain whether surgical or non-surgical treatment is the best approach. This is important as recurrent dislocation occurs in up to 40% of people who experience a first time (primary) dislocation. This can reduce quality of life and as a result people have to modify their lifestyle. This review is needed to determine whether surgical or non-surgical treatment should be offered to people after patellar dislocation. OBJECTIVES: To assess the effects (benefits and harms) of surgical versus non-surgical interventions for treating people with primary or recurrent patellar dislocation. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, AMED, CINAHL, Physiotherapy Evidence Database and trial registries in December 2021. We contacted corresponding authors to identify additional studies. SELECTION CRITERIA: We included randomised and quasi-randomised controlled clinical trials evaluating surgical versus non-surgical interventions for treating primary or recurrent lateral patellar dislocation in adults or children. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were recurrent patellar dislocation, and patient-rated knee and physical function scores. Our secondary outcomes were health-related quality of life, return to former activities, knee pain during activity or at rest, adverse events, patient-reported satisfaction, patient-reported knee instability symptoms and subsequent requirement for knee surgery. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included 10 studies (eight randomised controlled trials (RCTs) and two quasi-RCTs) of 519 participants with patellar dislocation. The mean ages in the individual studies ranged from 13.0 to 27.2 years. Four studies included children, mainly adolescents, as well as adults; two only recruited children. Study follow-up ranged from one to 14 years. We are unsure of the evidence for all outcomes in this review because we judged the certainty of the evidence to be very low. We downgraded each outcome by three levels. Reasons included imprecision (when fewer than 100 events were reported or the confidence interval (CI) indicated appreciable benefits as well as harms), risk of bias (when studies were at high risk of performance, detection and attrition bias), and inconsistency (in the event that pooled analysis included high levels of statistical heterogeneity). We are uncertain whether surgery lowers the risk of recurrent dislocation following primary patellar dislocation compared with non-surgical management at two to nine year follow-up. Based on an illustrative risk of recurrent dislocation in 348 people per 1000 in the non-surgical group, we found that 157 fewer people per 1000 (95% CI 209 fewer to 87 fewer) had recurrent dislocation between two and nine years after surgery (8 studies, 438 participants). We are uncertain whether surgery improves patient-rated knee and function scores. Studies measured this outcome using different scales (the Tegner activity scale, Knee Injury and Osteoarthritis Outcome Score, Lysholm, Kujala Patellofemoral Disorders score and Hughston visual analogue scale). The most frequently reported score was the Kujala Patellofemoral Disorders score. This indicated people in the surgical group had a mean score of 5.73 points higher at two to nine year follow-up (95% CI 2.91 lower to 14.37 higher; 7 studies, 401 participants). On this 100-point scale, higher scores indicate better function, and a change score of 10 points is considered to be clinically meaningful; therefore, this CI includes a possible meaningful improvement. We are uncertain whether surgery increases the risk of adverse events. Based on an assumed risk of overall incidence of complications during the first two years in 277 people out of 1000 in the non-surgical group, 335 more people per 1000 (95% CI 75 fewer to 723 more) had an adverse event in the surgery group (2 studies, 144 participants). Three studies (176 participants) assessed participant satisfaction at two to nine year follow-up, reporting little difference between groups. Based on an assumed risk of 763 per 1000 non-surgical participants reporting excellent or good outcomes, seven more participants per 1000 (95% CI 199 fewer to 237 more) reported excellent or good satisfaction. Four studies (256 participants) assessed recurrent patellar subluxation at two to nine year follow-up. Based on an assumed risk of patellar subluxation in 292 out of 1000 in the non-surgical group, 73 fewer people per 1000 (95% CI 146 fewer to 35 more) had patellar subluxation as a result of surgery. Slightly more people had subsequent surgery in the non-surgical group. Pooled two to nine year follow-up data from three trials (195 participants) indicated that, based on an assumed risk of subsequent surgery in 215 people per 1000 in the non-surgical group, 118 fewer people per 1000 (95% CI 200 fewer to 372 more) had subsequent surgery after primary surgery. AUTHORS' CONCLUSIONS: We are uncertain whether surgery improves outcome compared to non-surgical management as the certainty of the evidence was very low. No sufficiently powered trial has examined people with recurrent patellar dislocation. Adequately powered, multicentre, randomised trials are needed. To inform the design and conduct of these trials, expert consensus should be achieved on the minimal description of both surgical and non-surgical interventions, and the pathological variations that may be relevant to both choice of these interventions.

A radiological index that influences the outcome following patellofemoral joint arthroplasty: the anterior trochlea offset ratio.

PURPOSE: Although largely successful, patellofemoral joint arthroplasty (PFA) has a less than satisfactory outcome in some patients. It was hypothesized that certain factors can be identified on radiological review that correlate with poor patient reported outcomes following PFA. METHODS: A retrospective cohort review of 369 patients undergoing PFA at our institution between 2005 and 2018 identified 43 "poor outcome" patients with an Oxford Knee Score (OKS) of less than 20 at 2 years follow up. These cases were matched by sex and age with 43 "good outcome" patients who had an OKS above 40 at 2 years post-op. Multiple radiological measurements were performed including anterior trochlea offset ratio (ATOR), component flexion/extension, component varus/valgus, component to bone width ratio and retinacular index. The OKS PROM was the primary outcome of the study. Stepwise logistic regression was performed to analyze the differences in radiological indices between the two groups. RESULTS: Intraclass correlation coefficients for inter-observer and intra-observer reliability were 0.90-0.98 for all indices measured. The only index demonstrating statistical significance between the groups was the ATOR (p = 0.003). The good outcome group had a mean ATOR of 0.19 whereas the poor outcome group had a mean ATOR of 0.24. CONCLUSIONS: Lower ATOR on radiological review was strongly associated with improved outcomes following PFA. The surgeon should therefore take particular care to prevent increasing the anterior offset of the trochlea component when performing PFA. LEVEL OF EVIDENCE: Retrospective cohort study, Level III.

Bone bridge technique for lateral meniscal allograft transplantation: no difference in clinical outcome compared to the soft tissue technique.

PURPOSE: There is considerable debate regarding the optimal method of fixation for lateral meniscus allograft transplantation (MAT), with bone bridge techniques technically harder but allowing maintenance of root attachments, while soft tissue techniques are potentially more challenging for healing. The aim of this study was to compare the clinical results of the bone bridge and soft tissue techniques for lateral MAT in terms of failure, re-operation rate, complications and patient reported outcomes. METHODS: Retrospective analysis of prospectively collected data for patients undergoing primary lateral MAT with a minimum of 12-month follow-up. Patients following surgery utilising the bone bridge technique (BB) were compared with historical control patients who underwent MAT with the soft tissue technique (ST). Outcome was assessed by failure rate, defined as removal or revision of the meniscus transplant, survivorship by Kaplan-Meir analysis, re-operation rates, and other adverse event. Patient-reported outcome measures (PROMs) were compared using data at the 2-year point or 1 year if not reached 2 years. RESULTS: One-hundred and twelve patients following lateral meniscal transplants were included, 31 in the BB group and 81 in the ST historical control group, with no differences in demographics between both groups. Median follow-up for the BB group was 18 (12-43) months compared to 46 (15-62) months for the ST group. There were 3 failures (9.6%) in the BB group v 2 (2.4%) in the ST group (n.s.) with a mean time to failure of 9 months in both groups. 9 patients (29%) required a re-operation (all cause) in the BB group v 24 patients (29.6%) in the ST group (n.s). There was no difference in complications between both groups. There was significant improvement (p < 0.0001) in all PROMs (Tegner, IKDC, KOOS and Lysholm) between baseline and 2-year follow-up for both groups but no between-group differences. CONCLUSION: Lateral MAT has a high success rate for symptomatic meniscal deficiency with significant benefits irrespective of the fixation technique. There is no advantage in performing the more technically demanding BB technique over ST fixation. LEVEL OF EVIDENCE: Level 2.

What's important for recovery after a total knee replacement? A systematic review of mixed methods studies.

BACKGROUND: Understanding how patients perceive and prioritise various aspects of recovery following total knee replacement, including pain, function and return to activity, will help clinicians in pre-operative consultations by ensuring they effectively address patient concerns and managing their expectations. AIMS: The aim of this study is to identify aspects of recovery that are important to people after a total knee replacement. METHODS: Studies were identified from Medline, Embase, PsycInfo, Cochrane Library and Web of Science. This mixed methods review included all original study types (quantitative, qualitative, discrete choice experiments and mixed methods design). Reviews and non-peer-reviewed publications were excluded. Studies with participants (age ≥ 18 years) who had a primary TKR for osteoarthritis were included. Studies of people with unicompartmental knee, patella-femoral or revision knee replacement were excluded. Recovery attributes were extracted from individual papers and grouped into recovery themes. RESULTS: A total of 23 studies with 8404 participants and 18 recovery themes were developed. The most frequently identified overarching theme was pain, followed by activities of daily living, mobility (walking), recreational activities, specific functional movements of the knee, use of walking aids, sexual activity and range of motion of the knee. Medical complications were an infrequently reported theme, however, was deemed to be high importance. CONCLUSIONS: Reducing pain, returning of activities and daily living and mobility are the three most frequently reported recovery domains for people after TKR. Clinicians should be aware of recovery themes, to ensure they are explored sufficiently when consenting for a TKR. Future research should aim to determine the relative importance of these attributes compared to each other. Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021253699.

Influence of platelet-rich plasma (PRP) analogues on healing and clinical outcomes following anterior cruciate ligament (ACL) reconstructive surgery: a systematic review.

PURPOSE: To systematically review the effect of PRP on healing (vascularization, inflammation and ligamentization) and clinical outcomes (pain, knee function and stability) in patients undergoing ACL reconstruction and compare the preparation and application of PRP. METHODS: Independent systematic searches of online databases (Medline, Embase and Web of Science) were conducted following PRISMA guidelines (final search 10th July 2021). Studies were screened against inclusion criteria and risk of bias assessed using Critical appraisal skills programme (CASP) Randomised controlled trial (RCT) checklist. Independent data extraction preceded narrative analysis. RESULTS: 13 RCTs were included. The methods of PRP collection and application were varied. Significant early increases in rate of ligamentization and vascularisation were observed alongside early decreases in inflammation. No significant results were achieved in the later stages of the healing process. Significantly improved pain and knee function was found but no consensus reached. CONCLUSIONS: PRP influences healing through early vascularisation, culminating in higher rates of ligamentization. Long-term effects were not demonstrated suggesting the influence of PRP is limited. No consensus was reached on the impact of PRP on pain, knee stability and resultant knee function, providing avenues for further research. Subsequent investigations could incorporate multiple doses over time, more frequent observation and comparisons of different forms of PRP. The lack of standardisation of PRP collection and application techniques makes comparison difficult. Due to considerable heterogeneity, (I2 > 50%), a formal meta-analysis was not possible highlighting the need for further high quality RCTs to assess the effectiveness of PRP. The biasing towards young males highlights the need for a more diverse range of participants to make the study more applicable to the general population. TRAIL REGISTRATION: CRD42021242078CRD, 15th March 2021, retrospectively registered.

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.

Intracerebral hemorrhage markers on non-contrast computed tomography as predictors of the dynamic spot sign on CT perfusion and associations with hematoma expansion and outcome.

PURPOSE: To assess the association between non-contrast computed tomography (NCCT) hematoma markers and the dynamic spot sign on computed tomography perfusion (CTP), and their associations with hematoma expansion, clinical outcome, and in-hospital mortality. METHODS: Patients who presented with intracerebral hemorrhage (ICH) to a stroke center over an 18-month period and underwent baseline NCCT and CTP, and a follow-up NCCT within 24 h after the baseline scan were included. The initial and follow-up hematoma volumes were calculated. Two raters independently assessed the baseline NCCT for hematoma markers and concurrently assessed the CTP for the dynamic spot sign. Univariate and multivariate logistic regression analyses were performed to assess the association between the hematoma markers and the dynamic spot sign, adjusting for known ICH expansion predictors. RESULTS: Eighty-five patients were included in our study and 55 patients were suitable for expansion analysis. Heterogeneous density was the only NCCT hematoma marker to be associated with the dynamic spot sign after multivariate analysis (odds ratio, 58.61; 95% confidence interval, 9.13-376.05; P < 0.001). The dynamic spot sign was present in 22 patients (26%) and significantly predicted hematoma expansion (odds ratio, 36.6; 95% confidence interval, 2.51-534.2; P = 0.008). All patients with a spot sign had a swirl sign. A co-located hypodensity and spot sign was significantly associated with in-hospital mortality (odds ratio, 6.17; 95% confidence interval, 1.09-34.78; P = 0.039). CONCLUSION: Heterogeneous density and swirl sign are associated with the dynamic spot sign. The dynamic spot sign is a stronger predictor than NCCT hematoma markers of significant hematoma expansion. A co-located spot sign and hypodensity predicts in-hospital mortality.

Patient beliefs and perceptions play a crucial role in the decision-making process when managing a meniscal tear. A qualitative systematic review of the literature.

INTRODUCTION: There has been an increase in research on the effectiveness of treatment options for the management of meniscal tears. However, there is very little evidence about the patient experiences of meniscal tears. AIM: To summarise the available qualitative evidence on patients' experiences and expectations of meniscal tears. METHOD: A search of EMBASE, Medline, Sociofile and Web of Science up to November 2020 was performed to identify studies reporting patient experiences of meniscal tears. Studies were critically appraised using the CASP (Critical Appraisal Skills Program) checklist, and a meta-synthesis was performed to generate third-order constructs (new themes). RESULTS: Two studies reporting semi-structured interviews from 34 participants (24 male; 10 female) were included. The mean interview length ranged from 16 to 45 min. Five themes were generated: (1) the imaging (MRI) results are a key driver in the decision-making process, (2) surgery is perceived to be the definitive and quicker approach, (3) physiotherapy and exercise is a slower approach which brought success over time, (4) patient perceptions and preferences are important in the clinical decision-making process and, (5) the impact on patient lives is a huge driver in seeking care and treatment decisions. CONCLUSION: This is the first study to summarise the qualitative evidence on patient experiences with meniscal tears. The themes generated demonstrate the importance of patient perceptions of MRI findings and timing of treatment success as important factors in the decision-making process. This study demonstrates the need to strengthen our understanding of patients' experiences of meniscal tears.

Meniscal tears are more common than previously identified, however, less than a quarter of people with a tear undergo arthroscopy.

PURPOSE: The management of meniscal tears is a widely researched and evolving field. Previous studies reporting the incidence of meniscal tears are outdated and not representative of current practice. The aim of this study was to report the current incidence of MRI confirmed meniscal tears in patients with a symptomatic knee and the current intervention rate in a large NHS trust. METHODS: Radiology reports from 13,358 consecutive magnetic resonance imaging scans between 2015 and 2017, performed at a large UK hospital serving a population of 470,000, were assessed to identify patients with meniscal tears. The hospital database was interrogated to explore the subsequent treatment undertaken by the patient. A linear regression model was used to identify if any factors predicted subsequent arthroscopy. RESULTS: 1737 patients with isolated meniscal tears were identified in patients undergoing an MRI for knee pain, suggesting a rate of 222 MRI confirmed tears per 100,000 of the population aged 18 to 55 years old. 47% attended outpatient appointments and 22% underwent arthroscopy. Root tears [odds ratio (95% CI) 2.24 (1.0, 4.49); p = 0.049] and bucket handle tears were significantly associated with subsequent surgery, with no difference between the other types of tears. The presence of chondral changes did not significantly affect the rate of surgery [0.81 (0.60, 1.08); n.s]. CONCLUSION: Meniscal tears were found to be more common than previously described. However, less than half present to secondary care and only 22% undergo arthroscopy. These findings should inform future study design and recruitment strategies. In agreement with previous literature, bucket handle tears and root tears were significant predictors of subsequent surgery. LEVEL OF EVIDENCE: III.

Tourniquet use for knee replacement surgery.

BACKGROUND: Many surgeons prefer to perform total knee replacement surgery with the aid of a tourniquet. A tourniquet is an occlusive device that restricts distal blood flow to help create a bloodless field during the procedure. A tourniquet may be associated with increased risk of pain and complications. OBJECTIVES: To determine the benefits and harms of tourniquet use in knee replacement surgery. SEARCH METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to 26 March 2020. We searched clinicaltrials.gov, the World Health Organization trials portal, and several international registries and joint registries up to March 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing knee replacement with use of a tourniquet versus without use of a tourniquet and non-randomised studies with more than 1000 participants. Major outcomes included pain, function, global assessment of success, health-related quality of life, serious adverse events (including venous thromboembolism, infection, re-operation, and mortality), cognitive function, and survival of the implant. Minor outcomes included blood loss, economic outcomes, implant stability, and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors screened abstracts and full texts, extracted data, performed risk of bias assessments, and assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 41 RCTs with 2819 participants. Trials included from 20 to 199 participants. Mean age ranged between 58 and 84 years. More than half of the RCTs had unclear risk of selection bias and unclear risk of performance and detection bias due to absence of blinding of participants and surgeons. Major outcomes Pain: at postoperative day 1, pain (on a scale from zero to 10, with higher scores indicating worse pain) was ranked at 4.56 points after surgery without a tourniquet and at 1.25 points (MD) higher (95% CI 0.32 higher to 2.19 higher) with a tourniquet (8 studies; 577 participants), for an absolute difference of 12.5% higher pain scores (95% CI 3.2% higher to 21.9% higher) and a relative difference of 19% higher pain scores (95% CI 3.4% higher to 49% higher) with a tourniquet. Evidence for these findings was of moderate certainty, downgraded due to risk of bias. Knee replacement with a tourniquet probably led to higher postoperative pain scores at day 1, although this difference may or may not be noticeable to patients (based on a minimal clinically important difference (MCID) of 1.0). Function: at 12 months, tourniquet use probably makes little or no difference to function, based on an MCID of 5.3 for Knee Society Score (KSS) and 5.0 for Oxford Knee Score (OKS). Mean function (on a scale from 0 to 100, with higher scores indicating better outcomes) was 90.03 points after surgery without a tourniquet and was 0.29 points worse (95% CI 1.06 worse to 0.48 better) on a 0 to 100 scale, absolute difference was 0.29% worse (1.06% worse to 0.48% better), with a tourniquet (5 studies; 611 participants). This evidence was downgraded to moderate certainty due to risk of bias. Global assessment of success: low-certainty evidence (downgraded due to bias and imprecision) indicates that tourniquet use may have little or no effect on success. At six months, 47 of 50 (or 940 per 1000) reported overall successful treatment after surgery without a tourniquet and 47 of 50 (or 940 per 1000) with a tourniquet (risk ratio (RR) 1.0, 95% CI 0.91 to 1.10) based on one study with 100 participants. Health-related quality of life: at six months, tourniquet may have little or no effect on quality of life. The 12-Item Short Form Survey (SF-12) score (mental component from zero to 100 (100 is best)) was 54.64 after surgery without a tourniquet and 1.53 (MD) better (95% CI 0.85 worse to 3.91 better) with a tourniquet (1 study; 199 participants); absolute difference was 1.53% better (0.85% worse to 3.91% better). Evidence was of low certainty, downgraded due to risk of bias and small number of participants. Serious adverse events: the risk of serious adverse events was probably higher with tourniquet; 26 of 898 (29 per 1000) reported events following surgery without a tourniquet compared to 53 of 901 (59 per 1000) with a tourniquet (RR 1.73, 95% CI 1.10 to 2.73) in 21 studies (1799 participants). Twenty-nine more per 1000 patients (95% CI 3 to 50 more per 1000 patients) had a serious adverse event with a tourniquet. Forty-eight (95% CI 20 to 345) participants would need to have surgery without a tourniquet to avoid one serious adverse event. This evidence was downgraded to moderate certainty due to risk of bias. Cognitive function: one study reported cognitive function as an outcome; however the data were incompletely reported and could not be extracted for analysis. Survival of implant: it is uncertain if tourniquet has an effect on implant survival due to very low certainty evidence (downgraded for bias, and twice due to very low event rates); 2 of 107 (19 per 1000) required revision surgery in the surgery with a tourniquet group compared to 1 of 107 (9 per 1000) without a tourniquet group at up to two years' follow-up (RR 1.44, 95% CI 0.23 to 8.92). This equates to a 0.4% (0.7% lower to 7% more) increased absolute risk in surgery with a tourniquet. AUTHORS' CONCLUSIONS: Moderate certainty evidence shows that knee replacement surgery with a tourniquet is probably associated with an increased risk of serious adverse events. Surgery with a tourniquet is also probably associated with higher postoperative pain, although this difference may or may not be noticeable to patients. Surgery with a tourniquet does not appear to confer any clinically meaningful benefit on function, treatment success or quality of life. Further research is required to explore the effects of tourniquet use on cognitive function and implant survival, to identify any additional harms or benefits. If a tourniquet continues to be used in knee replacement surgery, patients should be informed about the potential increased risk of serious adverse events and postoperative pain.

ANTECEDENTES: Muchos cirujanos prefieren realizar una cirugía de reemplazo total de rodilla con la ayuda de un torniquete. Un torniquete es un dispositivo oclusivo que restringe el flujo sanguíneo distal para ayudar a crear un campo sin sangre durante el procedimiento. El torniquete se puede asociar con un mayor riesgo de dolor y complicaciones. OBJETIVOS: Determinar los efectos beneficiosos y perjudiciales del uso de torniquetes en la cirugía de reemplazo de rodilla. MÉTODOS DE BÚSQUEDA: Se hicieron búsquedas en MEDLINE, Embase y en el Registro Cochrane central de ensayos controlados (CENTRAL) hasta el 26 de marzo de 2020. Se realizaron búsquedas en clinicaltrials.gov, el portal de ensayos de la Organización Mundial de la Salud, y en varios registros internacionales y registros conjuntos hasta marzo de 2020. CRITERIOS DE SELECCIÓN: Se incluyeron los ensayos controlados aleatorizados (ECA) que compararon el reemplazo de rodilla con el uso de un torniquete versus sin el uso de un torniquete y los estudios no aleatorizados con más de 1000 participantes. Los desenlaces principales fueron el dolor, la funcionalidad, la evaluación general del éxito, la calidad de vida relacionada con la salud, los eventos adversos graves (incluido el tromboembolismo venoso, la infección, la reintervención y la mortalidad), la función cognitiva y la supervivencia del implante. Los desenlaces secundarios incluyeron la pérdida de sangre, los desenlaces económicos, la estabilidad del implante y los eventos adversos. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión examinaron los resúmenes y los textos completos, extrajeron los datos, realizaron las evaluaciones del riesgo de sesgo y evaluaron la certeza de la evidencia utilizando el enfoque GRADE. RESULTADOS PRINCIPALES: Se incluyeron 41 ECA con 2819 participantes. Los ensayos incluyeron de 20 a 199 participantes. La media de edad varió entre 58 y 84 años. Más de la mitad de los ECA tenían riesgo incierto de sesgo de selección y riesgo incierto de sesgo de realización y detección debido a la falta de cegamiento de los participantes y los cirujanos. Desenlaces principales Dolor: en el primer día después de la cirugía, el dolor (en una escala de 0 a 10, con puntuaciones mayores que indican un peor dolor) se clasificó en 4,56 puntos después de la cirugía sin torniquete y en 1,25 puntos (DM) mayor (IC del 95%: 0,32 mayor a 2,19 mayor) con un torniquete (ocho estudios; 577 participantes), para una diferencia absoluta de 12,5% de puntuaciones mayores de dolor (IC del 95%: 3,2% mayor a 21,9% mayor) y una diferencia relativa de 19% de puntuaciones mayores de dolor (IC del 95%: 3,4% mayor a 49% mayor) con un torniquete. La evidencia de estos hallazgos fue de certeza moderada, disminuida debido al riesgo de sesgo. El reemplazo de rodilla con un torniquete probablemente dio lugar a mayores puntuaciones de dolor en el primer día después de la cirugía, aunque esta diferencia puede o no ser perceptible para los pacientes (sobre la base de una diferencia mínima clínicamente importante [DMCI] de 1,0). Funcionalidad: a los 12 meses el uso de torniquetes probablemente da lugar a poca o ninguna diferencia en la funcionalidad, según una DMCI de 5,3 en la Knee Society Score (KSS) y de 5,0 en la Oxford Knee Score (OKS). La funcionalidad media (en una escala de 0 a 100, con puntuaciones más altas que indican mejores desenlaces) fue de 90,03 puntos después de la cirugía sin torniquete y fue 0,29 puntos peor (IC del 95%: 1,06 peor a 0,48 mejor) en una escala de 0 a 100, la diferencia absoluta fue 0,29% peor (1,06% peor a 0,48% mejor), con un torniquete (cinco estudios; 611 participantes). Esta evidencia se disminuyó a certeza moderada debido al riesgo de sesgo. Evaluación general del éxito: evidencia de certeza baja (disminuida debido al sesgo y la imprecisión) indica que el uso de torniquetes puede tener poco o ningún efecto en el éxito. A los seis meses, 47 de 50 (o 940 por 1000) informaron de un tratamiento general exitoso después de la cirugía sin torniquete y 47 de 50 (o 940 por 1000) con torniquete (razón de riesgos [RR] 1,0; IC del 95%: 0,91 a 1,10), según un estudio con 100 participantes. Calidad de vida relacionada con la salud: a los seis meses, el torniquete puede tener poco o ningún efecto en la calidad de vida. La puntuación de la 12­Item Short Form Survey (SF­12) (componente mental de 0 a 100 [100 es mejor]) fue de 54,64 después de la cirugía sin torniquete y 1,53 (DM) mejor (IC del 95%: 0,85 peor a 3,91 mejor) con torniquete (un estudio; 199 participantes); la diferencia absoluta fue 1,53% mejor (0,85% peor a 3,91% mejor). La evidencia fue de certeza baja, y se disminuyó debido al riesgo de sesgo y al escaso número de participantes. Eventos adversos graves: el riesgo de eventos adversos graves probablemente fue mayor con el uso de un torniquete; 26 de 898 (29 por 1000) notificaron eventos después de la cirugía sin torniquete en comparación con 53 de 901 (59 por 1000) con un torniquete (RR 1,73; IC del 95%: 1,10 a 2,73) en 21 estudios (1799 participantes). Veintinueve más por cada 1000 pacientes (95% CI 3 a 50 más por 1000 pacientes) presentaron un evento adverso grave con un torniquete. Cuarenta y ocho (IC del 95%: 20 a 345) participantes tendrían que ser operados sin torniquete para evitar un evento adverso grave. Esta evidencia se disminuyó a certeza moderada debido al riesgo de sesgo. Función cognitiva: un estudio informó de la función cognitiva como un desenlace; sin embargo, los datos se informaron de manera incompleta y no se pudieron extraer para el análisis. Supervivencia del implante: no está claro si el torniquete tiene un efecto sobre la supervivencia del implante debido a evidencia de certeza muy baja (disminuida por el sesgo, y dos veces debido a las tasas de eventos muy bajas); dos de 107 (19 por 1000) requirieron cirugía de revisión en el grupo de cirugía con torniquete en comparación con uno de 107 (nueve por 1000) en el grupo sin torniquete hasta los dos años de seguimiento (RR 1,44; IC del 95%: 0,23 a 8,92). Esto equivale a un 0,4% (0,7% menos a 7% más) de aumento del riesgo absoluto en la cirugía con torniquete. CONCLUSIONES DE LOS AUTORES: Evidencia de certeza moderada muestra que la cirugía de reemplazo de rodilla con torniquete probablemente se asocia con un mayor riesgo de eventos adversos graves. La cirugía con torniquete también se asocia probablemente con un mayor dolor posoperatorio, aunque esta diferencia puede o no ser perceptible para los pacientes. La cirugía con torniquete no parece conferir efectos beneficiosos clínicamente significativos en la funcionalidad, el éxito del tratamiento o la calidad de vida. Se necesitan estudios de investigación adicionales para explorar los efectos del uso de torniquetes en la función cognitiva y la supervivencia del implante, para identificar cualquier efecto perjudicial o beneficioso adicional. Si se sigue utilizando un torniquete en la cirugía de reemplazo de rodilla, se debe informar a los pacientes sobre el posible aumento del riesgo de que se produzcan efectos adversos graves y dolor posoperatorio.

The prevalence of obstructive sleep apnoea in women with polycystic ovary syndrome: a systematic review and meta-analysis.

BACKGROUND: Obesity is a common risk factor for polycystic ovary syndrome (PCOS) and obstructive sleep apnoea (OSA). Both PCOS and OSA are associated with increased risk of type 2 diabetes and cardiovascular disease. Hence, it is important to determine the burden of OSA in women with PCOS. METHODS: We searched electronic databases (MEDLINE, Embase, CINAHL, PsycINFO, Scopus, Web of Science, OpenGrey, CENTRAL), conference abstracts, and reference lists of relevant articles, up to January 2019. No restriction for language or publication status. Studies that examined the presence of OSA in women with PCOS using polysomnography and/or level III devices were eligible for inclusion. RESULTS: Seventeen studies involving 648 participants were included. Our meta-analysis showed that 35.0% (95% CI 22.2-48.9%) of women with PCOS had OSA. This prevalence was not affected by variation in PCOS definition between studies. Approximately one-tenth of the variation in OSA prevalence was related to differences in study population (higher in adults than adolescents and mixed populations), and around one-tenth was related to sample size (higher in smaller studies). OSA prevalence was markedly higher in obese versus lean women with PCOS, and in women with PCOS compared to controls (odds ratio = 3.83, 95% CI 1.43-10.24, eight studies, 957 participants (349 PCOS and 608 controls)). However, most of the studies were at high risk of selection bias, did not account for important confounders, included predominantly women with class II obesity, and were conducted in one country (USA). CONCLUSIONS: Future studies need to examine the true prevalence of OSA in a more representative sample of women with PCOS. Nevertheless, our results suggest that the prevalence of OSA in women with PCOS and obesity is high and clinicians should have a high index of suspicion of OSA in these women.

A patient satisfaction survey investigating pre- and post-operative information provision in lower limb surgery.

BACKGROUND: Planned lower limb surgery is common, with over 90,000 hip replacements, 95,000 knee replacements and 15,000 anterior cruciate ligament reconstructions performed in the UK each year. These procedures are primarily indicated to treat osteoarthritis, sporting injuries and trauma. Patient satisfaction is an important element of healthcare provision, which is usually measured by functional outcomes but influenced by other factors. Few studies have assessed patients' views on the information given to them pertaining surgery and patients are infrequently consulted when designing leaflets and information packs, which can lead to confusion during the recovery period and poor long-term outcomes. Furthermore, previous studies have not directly asked patients what resources they would prefer, or which format would suit them best. This project aimed to assess if patients were satisfied with the information they received around their operations and to identify potential improvements. METHODS: Set in a National Health Service (NHS) run major trauma centre in the West Midlands, a multiple choice and free-text answer survey was administered to patients who used the orthopaedic service over the course of 1 month. Surveys were designed in Qualtrics and administered face-to-face on paper. Thematic content analysis was performed on the results. RESULTS: Eighty patients completed the survey, of which 88.8% of patients were satisfied with the information they received. Discussions with surgeons were the most useful resource and 53% of patients requested more internet resources. Post-operative patients were statistically more likely to be dissatisfied with information provision than pre-operative patients. Over 20% of the study population requested more information on post-operative pain and recovery timelines. CONCLUSIONS: Although patients were satisfied in general, areas for change were identified. Suggested resources took the form of webpages and mobile platforms. These resources could contain educational videos, patient experience blogs or interactive recovery timelines, to be of benefit to patients. These suggestions may enable NHS Trusts to "get into the digital age", however, more research on patient satisfaction around information provision and the impact it has on recovery and decision making is needed.

Decreasing the number of arthroscopies in knee osteoarthritis - a service evaluation of a de-implementation strategy.

BACKGROUND: The Personalised Knee Improvement Programme (P-KIP) was developed based on previously published work, with the hypothesis that surgeons would refer patients to a well-structured conservative management intervention instead of for arthroscopy (de-implementation of arthroscopy by substitution with P-KIP). This meets NICE guidelines and international recommendations but such programmes are not widely used in the UK. Our aim was to determine whether P-KIP would reduce the number of arthroscopies performed for knee osteoarthritis. METHODS: P-KIP is a conservative care pathway including a group education session followed by individually tailored one-to-one dietician and physiotherapy sessions. Virtual clinic follow-up is conducted three to 6 months after completion of the programme. The service began in July 2015. The number of arthroscopies saved, measured from hospital level coding data, is the primary outcome measure. Interrupted time series analysis of coding data was conducted. As a quality assurance process, patient reported outcome measures (Oxford Knee Score; Euroqol 5D) were collected at baseline and at follow up. RESULTS: Time series analysis demonstrates that the programme saved 15.4 arthroscopies a month (95% confidence interval 9-21; p < 0.001), equating to 184 arthroscopies a year in a single hospital. The PROMs data demonstrated improvements in patient reported outcome scores consistent with previous published reports of conservative interventions in similar patient populations. CONCLUSIONS: Results suggest that P-KIP reduces the number of arthroscopies performed, and patients who took part in P-KIP had an improvement in their knee and general health outcomes. P-KIP has the potential to deliver efficiency savings and relive pressure on operative lists, however replication in other sites is required.

High tibial osteotomy results in improved frontal plane knee moments, gait patterns and patient-reported outcomes.

PURPOSE: The purpose of this study was to quantify changes in knee loading in the three clinical planes, compensatory gait adaptations and patient-reported outcome measures (PROMS) resulting from opening wedge high tibial osteotomy (HTO). METHODS: Gait analysis was performed on 18 participants (19 knees) with medial osteoarthritis (OA) and varus alignment pre- and post-HTO, along with 18 controls, to calculate temporal, kinematic and kinetic measures. Oxford Knee Score, Knee Outcome Survey and visual analogue pain scores were collected. Paired and independent sample tests identified changes following surgery and deviations from controls. RESULTS: HTO restored frontal and transverse plane knee joint loading to that of the control group, while reductions remained in the sagittal plane. Elevated frontal plane trunk sway (p = 0.031) and reduced gait speed (p = 0.042), adopted as compensatory gait changes pre-HTO, were corrected by the surgery. PROMs significantly improved (p ≤ 0.002). Centre of pressure (COP) was lateralised relative to the knee post-HTO (p < 0.001). Energy absorbed in the sagittal plane significantly increased post-HTO (p = 0.007), whilst work done in the transverse plane reduced (p ≤ 0.008). Pre-operative gait deviations from the control group that were retained post-HTO included smaller sagittal (p = 0.003) knee range of motion during gait, greater stance duration (p = 0.008) and altered COP location (anterior to the knee) in early stance (p = 0.025). CONCLUSIONS: HTO surgery restored frontal and transverse plane knee loading to normal levels and improved PROMs. Gait adaptations known to reduce knee loading employed pre-HTO were not retained post-HTO. Some gait features were found to differ between post-HTO subjects and controls. LEVEL OF EVIDENCE: II.

Using Bayesian adaptive designs to improve phase III trials: a respiratory care example.

BACKGROUND: Bayesian adaptive designs can improve the efficiency of trials, and lead to trials that can produce high quality evidence more quickly, with fewer patients and lower costs than traditional methods. The aim of this work was to determine how Bayesian adaptive designs can be constructed for phase III clinical trials in critical care, and to assess the influence that Bayesian designs would have on trial efficiency and study results. METHODS: We re-designed the High Frequency OSCillation in Acute Respiratory distress syndrome (OSCAR) trial using Bayesian adaptive design methods, to allow for the possibility of early stopping for success or futility. We constructed several alternative designs and studied their operating characteristics via simulation. We then performed virtual re-executions by applying the Bayesian adaptive designs using the OSCAR data to demonstrate the practical applicability of the designs. RESULTS: We constructed five alternative Bayesian adaptive designs and identified a preferred design based on the simulated operating characteristics, which had similar power to the original design but recruited fewer patients on average. The virtual re-executions showed the Bayesian sequential approach and original OSCAR trial yielded similar trial conclusions. However, using a Bayesian sequential design could have led to a reduced sample size and earlier completion of the trial. CONCLUSIONS: Using the OSCAR trial as an example, this case study found that Bayesian adaptive designs can be constructed for phase III critical care trials. If the OSCAR trial had been run using one of the proposed Bayesian adaptive designs, it would have terminated at a smaller sample size with fewer deaths in the trial, whilst reaching the same conclusions. We recommend the wider use of Bayesian adaptive approaches in phase III clinical trials. TRIAL REGISTRATION: OSCAR Trial registration ISRCTN, ISRCTN10416500 . Retrospectively registered 13 June 2007.

Allografts in reconstruction of the posterior cruciate ligament: a health economics perspective.

PURPOSE: To review the relative cost-effectiveness of allografts and autografts in reconstruction of the posterior cruciate ligament. METHODS: Systematic review and cost-effectiveness analysis. RESULTS: The available evidence does not show any significant difference in clinical effectiveness between autografts and allografts. Given that, only a cost analysis is provided, which shows that allografts are more costly. CONCLUSION: Given the lack of any benefit of allografts over autografts, autografts should be preferred on cost grounds, if available. However, there may be situations where an allograft is indicated, for example, in multiple ligament reconstructions. LEVEL OF EVIDENCE: IV.

Autograft or allograft for reconstruction of anterior cruciate ligament: a health economics perspective.

PURPOSE: To assess the clinical and cost-effectiveness of allografts versus autografts in the reconstruction of anterior cruciate ligaments. METHODS: Systematic review of comparative clinical effectiveness and cost-effectiveness analysis. RESULTS: Both autograft and allograft reconstruction are highly effective. Recent studies show little difference in failure rates between autografts and allografts (about 6% and 7%, respectively). In cost-effectiveness analysis, the price differential is the main factor, making autografts the first choice. However, there will be situations, particularly in revision ACL reconstruction, where an allograft may be preferred, or may be the only reasonable option available. CONCLUSION: In ACL reconstruction, clinical results with autografts are as good as or slightly better than with allografts. Allografts cost more, indicating that autografts are more cost-effective and should usually be first choice. LEVEL OF EVIDENCE: II.

The cost-effectiveness of osteochondral allograft transplantation in the knee.

PURPOSE: Osteochondral allografts (OCA) consist of a layer of hyaline cartilage and a layer of underlying bone. They are used to repair combined defects of articular cartilage and bone. Such defects often occur in people far too young to have knee arthroplasty, for whom the main alternative to OCA is conservative symptomatic care, which will not prevent development of osteoarthritis. The aim of this report was to assess the cost-effectiveness of osteochondral allograft transplantation in the knee. METHODS: Systematic review of evidence on clinical effectiveness and economic modelling. RESULTS: The evidence on osteochondral allograft transplantation comes from observational studies, but often based on good quality prospective registries of all patients having such surgery. Without controlled trials, it was necessary to use historical cohorts to assess the effect of osteochondral grafts. There is good evidence that OCA are clinically effective with a high graft survival rate over 20 years. If an OCA graft fails, there is some evidence that revision with a second OCA is also effective, though less so than primary OCA. Economic modelling showed that osteochondral allograft transplantation was highly cost-effective, with costs per quality adjusted life year much lower than many other treatments considered cost effective. CONCLUSIONS: Osteochondral allograft transplantation appears highly cost-effective though the cost per quality adjusted life year varies according to the widely varying costs of allografts. Based on one small study, revision OCA also appears very cost-effective, but more evidence is needed. LEVEL OF EVIDENCE: II.