Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial.

BACKGROUND: Anterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability. METHODS: We did a pragmatic, multicentre, superiority, randomised controlled trial in 29 secondary care National Health Service orthopaedic units in the UK. Patients with symptomatic knee problems (instability) consistent with an ACL injury were eligible. We excluded patients with meniscal pathology with characteristics that indicate immediate surgery. Patients were randomly assigned (1:1) by computer to either surgery (reconstruction) or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment), stratified by site and baseline Knee Injury and Osteoarthritis Outcome Score-4 domain version (KOOS4). This management design represented normal practice. The primary outcome was KOOS4 at 18 months after randomisation. The principal analyses were intention-to-treat based, with KOOS4 results analysed using linear regression. This trial is registered with ISRCTN, ISRCTN10110685, and ClinicalTrials.gov, NCT02980367. FINDINGS: Between Feb 1, 2017, and April 12, 2020, we recruited 316 patients. 156 (49%) participants were randomly assigned to the surgical reconstruction group and 160 (51%) to the rehabilitation group. Mean KOOS4 at 18 months was 73·0 (SD 18·3) in the surgical group and 64·6 (21·6) in the rehabilitation group. The adjusted mean difference was 7·9 (95% CI 2·5-13·2; p=0·0053) in favour of surgical management. 65 (41%) of 160 patients allocated to rehabilitation underwent subsequent surgery according to protocol within 18 months. 43 (28%) of 156 patients allocated to surgery did not receive their allocated treatment. We found no differences between groups in the proportion of intervention-related complications. INTERPRETATION: Surgical reconstruction as a management strategy for patients with non-acute ACL injury with persistent symptoms of instability was clinically superior and more cost-effective in comparison with rehabilitation management. FUNDING: The UK National Institute for Health Research Health Technology Assessment Programme.

Effectiveness of nail bed repair in children with or without replacing the fingernail: NINJA multicentre randomized clinical trial.

BACKGROUND: Surgery for nail bed injuries in children is common. One of the key surgical decisions is whether to replace the nail plate following nail bed repair. The aim of this RCT was to assess the clinical effectiveness and cost-effectiveness of nail bed repair with fingernail replacement/substitution compared with repair without fingernail replacement. METHODS: A two-arm 1 : 1 parallel-group open multicentre superiority RCT was performed across 20 secondary-care hospitals in the UK. The co-primary outcomes were surgical-site infection at around 7 days after surgery and cosmetic appearance summary score at a minimum of 4 months. RESULTS: Some 451 children presenting with a suspected nail bed injury were recruited between July 2018 and July 2019; 224 were allocated to the nail-discarded arm, and 227 to the nail-replaced arm. There was no difference in the number of surgical-site infections at around 7 days between the two interventions or in cosmetic appearance. The mean total healthcare cost over the 4 months after surgery was €84 (95 per cent c.i. 34 to 140) lower for the nail-discarded arm than the nail-replaced arm (P < 0.001). CONCLUSION: After nail bed repair, discarding the fingernail was associated with similar rates of infection and cosmesis ratings as replacement of the finger nail, but was cost saving. Registration number: ISRCTN44551796 (http://www.controlled-trials.com).

Remote Symptom Monitoring With Ecological Momentary Computerized Adaptive Testing: Pilot Cohort Study of a Platform for Frequent, Low-Burden, and Personalized Patient-Reported Outcome Measures.

BACKGROUND: Remote patient-reported outcome measure (PROM) data capture can provide useful insights into research and clinical practice and deeper insights can be gained by administering assessments more frequently, for example, in ecological momentary assessment. However, frequent data collection can be limited by the burden of multiple, lengthy questionnaires. This burden can be reduced with computerized adaptive testing (CAT) algorithms that select only the most relevant items from a PROM for an individual respondent. In this paper, we propose "ecological momentary computerized adaptive testing" (EMCAT): the use of CAT algorithms to reduce PROM response burden and facilitate high-frequency data capture via a smartphone app. We develop and pilot a smartphone app for performing EMCAT using a popular hand surgery PROM. OBJECTIVE: The aim of this study is to determine the feasibility of EMCAT as a system for remote PROM administration. METHODS: We built the EMCAT web app using Concerto, an open-source CAT platform maintained by the Psychometrics Centre, University of Cambridge, and hosted it on an Amazon Web Service cloud server. The platform is compatible with any questionnaire that has been parameterized with item response theory or Rasch measurement theory. For this study, the PROM we chose was the patient evaluation measure, which is commonly used in hand surgery. CAT algorithms were built using item response theory models derived from UK Hand Registry data. In the pilot study, we enrolled 40 patients with hand trauma or thumb-base arthritis, across 2 sites, between July 13, 2022, and September 14, 2022. We monitored their symptoms with the patient evaluation measure, via EMCAT, over a 12-week period. Patients were assessed thrice weekly, once daily, or thrice daily. We additionally administered full-length PROM assessments at 0, 6, and 12 weeks, and the User Engagement Scale at 12 weeks. RESULTS: The use of EMCAT significantly reduced the length of the PROM (median 2 vs 11 items) and the time taken to complete it (median 8.8 seconds vs 1 minute 14 seconds). Very similar scores were obtained when EMCAT was administered concurrently with the full-length PROM, with a mean error of <0.01 on a logit (z score) scale. The median response rate in the daily assessment group was 93%. The median perceived usability score of the User Engagement Scale was 4.0 (maximum possible score 5.0). CONCLUSIONS: EMCAT reduces the burden of PROM assessments, enabling acceptable high-frequency, remote PROM data capture. This has potential applications in both research and clinical practice. In research, EMCAT could be used to study temporal variations in symptom severity, for example, recovery trajectories after surgery. In clinical practice, EMCAT could be used to monitor patients remotely, prompting early intervention if a patient's symptom trajectory causes clinical concern. TRIAL REGISTRATION: ISRCTN 19841416; https://www.isrctn.com/ISRCTN19841416.

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.

Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.

Patient-Reported Function and Quality of Life After Revision Total Knee Arthroplasty: An Analysis of 10,727 Patients from the NHS PROMs Program.

BACKGROUND: The aim of the study was to investigate changes in patient-reported outcome measures (PROMs) after revision total knee arthroplasty (rTKA). METHODS: A total of 10,727 patients undergoing elective rTKA were recruited from the UK National Health Service PROMs data set from 2013 to 2019. PROMs were collected at baseline and six months to assess joint function (Oxford Knee Score, OKS) and quality of life (EQ-5D). Associations with a change in the OKS (COKS) were investigated through multiple linear regression. RESULTS: The mean COKS was 12.4 (standard deviation 10.7) points. A total of 6776 of 10,329 (65.6%) patients demonstrated increase in the OKS above the minimal important change of 7.5 points. The median change in the EQ-5D utility was 0.227 (interquartile range 0.000 to 0.554). A total of 4917 of 9279 (53.0%) patients achieved a composite endpoint of improvement greater than the minimal important change for joint function and 'better' QoL as per the Paretian analysis. A total of 7477 of 10,727 (69.7%) patients reported satisfaction with rTKA. A total of 7947 of 10,727 (74.1%) patients felt surgery was a success. A total of 4888 of 10,632 (46.0%) patients reported one or more adverse events. A higher preoperative OKS was associated with a lower COKS (coefficient -0.63 [95% confidence interval -0.67 to -0.60]). Other factors associated with a lower COKS were postoperative complication(s), age under 60 years, longer duration of knee problems, patients who identified as disabled, problems in EQ-5D dimensions of anxiety/depression and self-care, comorbid conditions (circulatory problems, diabetes, and depression), and earlier year of procedure in the data set. CONCLUSION: Two-thirds of patients experienced a meaningful improvement in joint function after rTKA. However, there was a high frequency of patient-reported complications. These findings may enable better informed discussion of the risks and benefits of discretionary rTKA.

The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial.

BACKGROUND: Late-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years. METHODS: Our multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov (NCT01352247). FINDINGS: Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI -0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (-£910, 95% CI -1503 to -317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR. INTERPRETATION: Both TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

Anterior cruciate ligament (ACL) reconstruction and meniscal repair rates have both increased in the past 20 years in England: hospital statistics from 1997 to 2017.

OBJECTIVES: We investigated the temporal trend and the geographical variation in the rate of an anterior cruciate ligament (ACL) reconstruction and meniscal repair (MR) performed in England during a 20-year window. METHODS: All hospital episodes for patients undergoing ACL reconstruction or MR between 1 April 1997 and 31 March 2017 were extracted by procedure code from the national hospital episode statistics. Age-standardised and sex-standardised rates of surgery were calculated using Office for National Statistics population data as the denominator and analysed over time both nationally and regionally by National Health Service clinical commissioning group (CCG). RESULTS: Between 1997-1998 and 2016-2017, there were 133 270 cases of ACL reconstruction (124 489 patients) and 42 651 cases of MR (41 120 patients) (isolated or simultaneous). Nationally, the rate of ACL reconstruction increased 12-fold from 2.0/100K population (95% CI 1.9 to 2.1) in 1997-1998 to 24.2/100K (95% CI 23.8 to 24.6) in 2016-2017. The rate of MR increased more than twofold from 3.0/100K (95% CI 2.8 to 3.1) in 1997-1998 to 7.3/100K (95% CI 7.1 to 7.5) in 2016-2017. Of these cases, the rate of simultaneous ACL reconstruction and MR was 2.6/100K (95% CI 2.5 to 2.8) in 2016/2017. In 2016-2017, for patients aged 20-29, the sex-standardised rate of ACL reconstruction was 76.9/100K (95% CI 74.9 to 78.9) and for MR was 19.8/100K (95% CI 18.8 to 20.9). Practice varied by region-in 2016-2017, 14.5% (30/207) of the CCGs performed more than twice the national average rate of ACL reconstruction and 15.0% (31/207) performed more than twice the national average rate of MR. CONCLUSIONS: The rate of ACL reconstruction (12-fold) and MR (2.4-fold) has increased in England over the last two decades. There is variation in these rates across geographical regions and further work is required to deliver standardised treatment guidance for appropriate use.

Arthroscopic partial meniscectomy for meniscal tears of the knee: a systematic review and meta-analysis.

OBJECTIVE: To assess the benefit of arthroscopic partial meniscectomy (APM) in adults with a meniscal tear and knee pain in three defined populations (taking account of the comparison intervention): (A) all patients (any type of meniscal tear with or without radiographic osteoarthritis); (B) patients with any type of meniscal tear in a non-osteoarthritic knee; and (C) patients with an unstable meniscal tear in a non-osteoarthritic knee. DESIGN: Systematic review and meta-analysis. DATASOURCES: A search of MEDLINE, Embase, CENTRAL, Scopus, Web of Science, Clinicaltrials.gov and ISRCTN was performed, unlimited by language or publication date (inception to 18 October 2018). ELIGIBILITYCRITERIA: Randomised controlled trials performed in adults with meniscal tears, comparing APM versus (1) non-surgical intervention; (2) pharmacological intervention; (3) surgical intervention; and (4) no intervention. RESULTS: Ten trials were identified: seven compared with non-surgery, one pharmacological and two surgical. Findings were limited by small sample size, small number of trials and cross-over of participants to APM from comparator interventions. In group A (all patients) receiving APM versus non-surgical intervention (physiotherapy), at 6-12 months, there was a small mean improvement in knee pain (standardised mean difference [SMD] 0.22 [95% CI 0.03 to 0.40]; five trials, 943 patients; I2 48%; Grading of Recommendations Assessment, Development and Evaluation [GRADE]: low), knee-specific quality of life (SMD 0.43 [95% CI 0.10 to 0.75]; three trials, 350 patients; I2 56%; GRADE: low) and knee function (SMD 0.18 [95% CI 0.04 to 0.33]; six trials, 1050 patients; I2 27%; GRADE: low). When the analysis was restricted to people without osteoarthritis (group B), there was a small to moderate improvement in knee pain (SMD 0.35 [95% CI 0.04 to 0.66]; three trials, 402 patients; I2 58%; GRADE: very low), knee-specific quality of life (SMD 0.59 [95% CI 0.11 to 1.07]; two trials, 244 patients; I2 71%; GRADE: low) and knee function (SMD 0.30 [95% CI 0.06 to 0.53]; four trials, 507 patients; I2 44%; GRADE: very low). There was no improvement in knee pain, function or quality of life in patients receiving APM compared with placebo surgery at 6-12 months in group A or B (pain: SMD 0.08 [95% CI -0.24 to 0.41]; one trial, 146 patients; GRADE: low; function: SMD -0.08 [95% CI -0.41 to 0.24]; one trial, 146 patients; GRADE: high; quality of life: SMD 0.05 [95% CI -0.27 to 0.38]; one trial; 146 patients; GRADE: high). No trials were identified for people in group C. CONCLUSION: Performing APM in all patients with knee pain and a meniscal tear is not appropriate, and surgical treatment should not be considered the first-line intervention. There may, however, be a small-to-moderate benefit from APM compared with physiotherapy for patients without osteoarthritis. No trial has been limited to patients failing non-operative treatment or patients with an unstable meniscal tear in a non-arthritic joint; research is needed to establish the value of APM in this population. PROTOCOL REGISTRATION NUMBER: PROSPERO CRD42017056844.

Varus alignment of the proximal tibia is associated with structural progression in early to moderate varus osteoarthritis of the knee.

PURPOSE: Lower limb malalignment is a strong predictor of progression in knee osteoarthritis. The purpose of this study is to identify the individual alignment variables that predict progression in early to moderate osteoarthritis of the knee. METHOD: A longitudinal cohort study using data from the Osteoarthritis Initiative. In total, 955 individuals (1329 knees) with early to moderate osteoarthritis (Kellgren-Lawrence grade 1, 2 or 3) were identified. All subjects had full-limb radiographs analysed using the Osteotomy module within Medicad® Classic (Hectec GMBH) to give a series of individual alignment variables relevant to the coronal alignment of the lower limb. Logistic regression models, with generalised estimating equations were used to identify which of these individual alignment variables predict symptom worsening (WOMAC score > 9 points) and or structural progression (joint space narrowing progression in the medial compartment > 0.7mm) over 24 months. RESULTS: Individual alignment variable were associated with both valgus and varus alignment (mechanical Lateral Distal Femoral Angle, Medial Proximal Tibial Angle and mechanical Lateral Distal Tibial Angle). Only the Medial Proximal Tibial Angle was significantly associated with structural progression and none of the variables was associated with symptom progression. The odds of joint space narrowing progression in the medial compartment occurring at 24 months increased by 21% for every one degree decrease (more varus) in Medial Proximal Tibial Angle (p < 0.001) CONCLUSIONS: Our results suggest that the risk of structural progression in the medial compartment is associated with greater varus alignment of the proximal tibia. LEVEL OF EVIDENCE: Level III, retrospective cohort study.

Manipulation Under Anesthetic After Primary Knee Arthroplasty Is Associated With a Higher Rate of Subsequent Revision Surgery.

AIM: To determine the association between manipulation under anesthetic (MUA) after primary knee arthroplasty and subsequent revision surgery. METHODS: Patients undergoing primary knee arthroplasty from April 2011 to April 2016 with minimum 1-year follow-up to April 2017 were identified from the national hospital episode statistics for England. The first arthroplasty per patient, per side, was included; cases with a record of subsequent infection or periprosthetic fracture were excluded. Patients undergoing MUA within 1 year to the same knee were identified, defining the populations for the MUA and non-MUA cohorts. Mortality-adjusted Kaplan-Meier survival analysis (revision arthroplasty) was performed to a maximum of 6 years. A Cox proportional hazards model was used to determine the hazard for revision, adjusting for type of primary arthroplasty, gender, age group, year, comorbidity index, obesity, regional deprivation, rurality, and ethnicity. RESULTS: A total of 309,650 primary arthroplasty cases (309,650 patients) were included. MUA within 1 year was recorded in 6882 patients (2.22%; 95% confidence interval [95% CI], 2.17-2.28) defining the MUA cohort; all others were included in the parallel non-MUA cohort. At 6 years, the mortality-adjusted estimated implant survival rate in the MUA cohort was 91.2% (95% CI, 90.0-92.2) in comparison to 98.1% (95% CI, 98.0-98.2) in the non-MUA cohort. In the fully adjusted model, this corresponded to an adjusted hazard for revision of 5.03 (hazard ratio; 95% CI, 4.55-5.57). CONCLUSION: Patients who underwent MUA within 1 year of primary arthroplasty were at a 5-fold increased risk of subsequent revision even after excluding cases of infection or fracture. Further investigation of the etiology of stiffness after primary knee arthroplasty and the optimal treatment options to improve outcomes is justified.

Adverse outcomes after arthroscopic partial meniscectomy: a study of 700 000 procedures in the national Hospital Episode Statistics database for England.

BACKGROUND: Arthroscopic partial meniscectomy is one of the most common orthopaedic procedures worldwide. Clinical trial evidence published in the past 6 years, however, has raised questions about the effectiveness of the procedure in some patient groups. In view of concerns about potential overuse, we aimed to establish the true risk of serious complications after arthroscopic partial meniscectomy. METHODS: We analysed national Hospital Episode Statistics data for all arthroscopic partial meniscectomies done in England between April 1, 1997, and March 31, 2017. Simultaneous or staged (within 6 months) bilateral cases were excluded. We identified complications occurring in the 90 days after the index procedure. The primary outcome was the occurrence of at least one serious complication within 90 days, which was defined as either myocardial infarction, stroke, pulmonary embolism, infection requiring surgery, fasciotomy, neurovascular injury, or death. Logistic regression modelling was used to identify factors associated with complications and, when possible, risk was compared with general population data. FINDINGS: During the study period 1 088 782 arthroscopic partial meniscectomies were done, 699 965 of which were eligible for analysis. Within 90 days, serious complications occurred in 2218 (0·317% [95% CI 0·304-0·330]) cases, including 546 pulmonary embolisms (0·078% [95% CI 0·072-0·085]) and 944 infections necessitating further surgery (0·135% [95% CI 0·126-0·144]). Increasing age (adjusted odds ratio [OR] 1·247 per decade [95% CI 1·208-1·288) and modified Charlson comorbidity index (adjusted OR 1·860 per 10 units [95% CI 1·708-2·042]) were associated with an increased risk of serious complications. Female sex was associated with a reduced risk of serious complications (adjusted OR 0·640 [95% CI 0·580-0·705). The risk of mortality fell over time (adjusted OR 0·965 per year [95% CI 0·937-0·994]). Mortality, myocardial infarction, and stroke occurred less frequently in the study cohort than in the general population. The risks of infection and pulmonary embolism did not change during the study, and were significantly higher in the study cohort than in the general population. For every 1390 (95% CI 1272-1532) fewer knee arthroscopies done, one pulmonary embolism could be prevented. For every 749 (95% CI 704-801) fewer procedures done, one native knee joint infection could be prevented. INTERPRETATION: Overall, the risk associated with undergoing arthroscopic partial meniscectomy was low. However, some rare but serious complications (including pulmonary embolism and infection) are associated with the procedure, and the risks have not fallen with time. In view of uncertainty about the effectiveness of arthroscopic partial meniscectomy, an appreciation of relative risks is crucial for patients and clinicians. Our data provide a basis for decision making and consent. FUNDING: UK National Institute for Health Research.

Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial.

BACKGROUND: Arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression. METHODS: We did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011. FINDINGS: Between Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference -1·3 points (95% CI -3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5-5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8-6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group). INTERPRETATION: Surgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process. FUNDING: Arthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).

Surgical interventions for symptomatic mild to moderate knee osteoarthritis.

BACKGROUND: Osteoarthritis affecting the knee is common and represents a continuum of disease from early cartilage thinning to full-thickness cartilage loss, bony erosion, and deformity. Many studies do not stratify their results based on the severity of the disease at baseline or recruitment. OBJECTIVES: To assess the benefits and harms of surgical intervention for the management of symptomatic mild to moderate knee osteoarthritis defined as knee pain and radiographic evidence of non-end stage osteoarthritis (Kellgren-Lawrence grade 1, 2, 3 or equivalent on MRI/arthroscopy). Outcomes of interest included pain, function, radiographic progression, quality of life, short-term serious adverse events, re-operation rates and withdrawals due to adverse events. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase up to May 2018. We also conducted searches of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for ongoing trials. Authors of trials were contacted if some but not all their participants appeared to fit our inclusion criteria. SELECTION CRITERIA: We included randomised controlled trials that compared surgery to non-surgical interventions (including sham and placebo control groups, exercise or physiotherapy, and analgesic or other medication), injectable therapies, and trials that compared one type of surgical intervention to another surgical intervention in people with symptomatic mild to moderate knee osteoarthritis. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials and extracted data using standardised forms. We analysed the quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach. MAIN RESULTS: A total of five studies involving 566 participants were identified as eligible for this review. Single studies compared arthroscopic partial meniscectomy to physical therapy (320 participants), arthroscopic surgery (debridement ± synovectomy ± chondroplasty) to closed needle joint lavage with saline (32 participants) and high tibial osteotomy surgery to knee joint distraction surgery (62 participants). Two studies (152 participants) compared arthroscopic surgery (washout ± debridement; debridement) to a hyaluronic acid injection. Only one study was at low risk of selection bias, and due to the difficulty of blinding participants to their treatment, all studies were at risk of performance and detection bias.Reporting of results in this summary has been restricted to the primary comparison: surgical intervention versus non-surgical intervention.A single study, included 320 participants with symptoms consistent with meniscal tear. All subjects had the meniscal tear confirmed on knee MRI and radiographic evidence of mild to moderate osteoarthritis (osteophytes, cartilage defect or joint space narrowing). Patients with severe osteoarthritis (KL grade 4) were excluded. The study compared arthroscopic partial meniscectomy and physical therapy to physical therapy alone (a six-week individualised progressive home exercise program). This study was at low risk of selection bias and outcome reporting biases, but was susceptible to performance and detection biases. A high rate of cross-over (30.2%) occurred from the physical therapy group to the arthroscopic group.Low-quality evidence suggests there may be little difference in pain and function at 12 months follow-up in people who have arthroscopic partial meniscectomy and those who have physical therapy. Evidence was downgraded to low quality due to risk of bias and imprecision.Mean pain was 19.3 points on a 0 to 100 point KOOS pain scale with physical therapy at 12 months follow-up and was 0.2 points better with surgery (95% confidence interval (CI) 4.05 better to 3.65 points worse with surgery, an absolute improvement of 0.2% (95% CI 4% better to 4% worse) and relative improvement 0.4% (95% CI 9% better to 8% worse) (low quality evidence). Mean function was 14.5 on a 0 to 100 point KOOS function scale with physical therapy at 12 months follow-up and 0.8 points better with surgery (95% CI 4.3 better to 2.7 worse); 0.8% absolute improvement (95% CI 4% better to 3% worse) and 2.1% relative improvement (95% CI 11% better to 7% worse) (low quality evidence).Radiographic structural osteoarthritis progression and quality of life outcomes were not reported.Due to very low quality evidence, we are uncertain if surgery is associated with an increased risk of serious adverse events, incidence of total knee replacement or withdrawal rates. Evidence was downgraded twice due to very low event rates, and once for risk of bias.At 12 months, the surgery group had a total of three serious adverse events including fatal pulmonary embolism, myocardial infarction and hypoxaemia. The physical therapy alone group had two serious adverse events including sudden death and stroke (Peto OR 1.58, 95% CI 0.27 to 9.21); 1% more events with surgery (95% CI 2% less to 3% more) and 58% relative change (95% CI 73% less to 821% more). One participant in each group withdrew due to adverse events.Two of 164 participants (1.2%) in the physical therapy group and three of 156 in the surgery group underwent conversion to total knee replacement within 12 months (Peto OR 1.76, 95% CI 0.43 to 7.13); 1% more events with surgery (95% CI 2% less to 5% more); 76% relative change (95% CI 57% less to 613% more). AUTHORS' CONCLUSIONS: The review found no placebo-or sham-controlled trials of surgery in participants with symptomatic mild to moderate knee osteoarthritis. There was low quality evidence that there may be no evidence of a difference between arthroscopic partial meniscectomy surgery and a home exercise program for the treatment of this condition. Similarly, low-quality evidence from a few small trials indicates there may not be any benefit of arthroscopic surgery over other non-surgical treatments including saline irrigation and hyaluronic acid injection, or one type of surgery over another. We are uncertain of the risk of adverse events or of progressing to total knee replacement due to very small event rates. Thus, there is uncertainty around the current evidence to support or oppose the use of surgery in mild to moderate knee osteoarthritis. As no benefit has been demonstrated from the low quality trials included in this review, it is possible that future higher quality trials for these surgical interventions may not contradict these results.

Temporal trends and regional variation in the rate of arthroscopic knee surgery in England: analysis of over 1.7 million procedures between 1997 and 2017. Has practice changed in response to new evidence?

OBJECTIVES: We investigated trends and regional variation in the rate of arthroscopic knee surgery performed in England from 1997-1998 to 2016-2017. DESIGN: Cross-sectional study of the national hospital episode statistics (HES) for England. METHODS: All hospital episodes for patients undergoing a knee arthroscopy between 1 April 1997 and 31 March 2017 were extracted from HES by procedure code. Age and sex-standardised rates of surgery were calculated using Office for National Statistic population data as the denominator. Trends in the rate of surgery were analysed by procedure both nationally and by Clinical Commissioning Group (CCG). RESULTS: A total of 1 088 872 arthroscopic partial meniscectomies (APMs), 326 600 diagnostic arthroscopies, 308 618 knee washouts and 252 885 chondroplasties were identified (1 759 467 hospital admissions; 1 447 142 patients). The rate of APM increased from a low of 51/100 000 population (95% CI 51 to 52) in 1997-1998 to a peak at 149/100 000 (95% CI 148 to 150) in 2013-2014; then, after 2014-2015, rates declined to 120/100 000 (95% CI 119 to 121) in 2016-2017. Rates of arthroscopic knee washout and diagnostic arthroscopy declined steadily from 50/100 000 (95% CI 49 to 50) and 47/100 000 (95% CI 46 to 47) respectively in 1997-1998, to 4.8/100 000 (95% CI 4.6 to 5.0) and 8.1/100 000 (95% CI 7.9 to 8.3) in 2016-2017. Rates of chondroplasty have increased from a low of 3.2/100 000 (95% CI 3.0 to 3.3) in 1997-1998 to 51/100 000 (95% CI 50.6 to 51.7) in 2016-2017. Substantial regional and age-group variation in practice was detected. In 2016-2017, between 11% (22/207) and 16% (34/207) of CCGs performed at least double the national average rate of each procedure. CONCLUSIONS: Over the last 20 years, and likely in response to new evidence, rates of arthroscopic knee washout and diagnostic arthroscopy have declined by up to 90%. APM rates increased about 130% overall but have declined recently. Rates of chondroplasty increased about 15-fold. There is significant variation in practice, but the appropriate population intervention rate for these procedures remains unknown.

Rates of knee arthroplasty in anterior cruciate ligament reconstructed patients: a longitudinal cohort study of 111,212 procedures over 20 years.

Background and purpose - Long-term rates of knee arthroplasty in patients with anterior cruciate ligament (ACL) injury who undergo ligament reconstruction (ACLr) are unclear. We determined this risk of arthroplasty through comparison with the general population.Patients and methods - All patients undergoing an ACLr in England, 1997-2017, were identified from national hospital statistics. Patients subsequently undergoing a knee arthroplasty were identified and survival analysis was performed (survival without undergoing knee arthroplasty). A Cox proportional hazards model was used to identify factors associated with knee arthroplasty. Relative risk of knee arthroplasty (total or partial) in comparison with the general population was determined.Results - 111,212 ACLr patients were eligible for analysis (mean age 29; 77% male). Overall, 0.46% (95% confidence interval [CI] 0.40-0.52) ACLr patients underwent knee arthroplasty within 5 years, 0.97% (CI 0.82-1.2) within 10 years, and 1.8% (CI 1.4-2.3) within 15 years. Knee arthroplasty risk was greater in older age groups and women. In comparison with the general population, the relative risk of undergoing arthroplasty at a younger age (at time of arthroplasty) was elevated: at 30-39 years (risk ratio [RR] 20; CI 11-35), 40-49 years (RR 7.5; CI 5.5-10), and 50-59 years (RR 2.5; CI 1.8-3.5), but not 60-69 years (RR 1.7; CI 0.93-3.2).Interpretation - Patients sustaining an ACL injury who undergo ACLr are at elevated risk of subsequent knee arthroplasty in comparison with the general population. Although the absolute rate of arthroplasty is low, the risk of arthroplasty at a younger age is particularly elevated. When the outcome of shared decision-making is ACLr, this data will help inform patients and clinicians about the long-term risk of requiring knee arthroplasty.

The effect of patient age at intervention on risk of implant revision after total replacement of the hip or knee: a population-based cohort study.

BACKGROUND: Total joint replacements for end-stage osteoarthritis of the hip and knee are cost-effective and demonstrate significant clinical improvement. However, robust population based lifetime-risk data for implant revision are not available to aid patient decision making, which is a particular problem in young patient groups deciding on best-timing for surgery. METHODS: We did implant survival analysis on all patients within the Clinical Practice Research Datalink who had undergone total hip replacement or total knee replacement. These data were adjusted for all-cause mortality with data from the Office for National Statistics and used to generate lifetime risks of revision surgery based on increasing age at the time of primary surgery. FINDINGS: We identified 63 158 patients who had undergone total hip replacement and 54 276 who had total knee replacement between Jan 1, 1991, and Aug 10, 2011, and followed up these patients to a maximum of 20 years. For total hip replacement, 10-year implant survival rate was 95·6% (95% CI 95·3-95·9) and 20-year rate was 85·0% (83·2-86·6). For total knee replacement, 10-year implant survival rate was 96·1% (95·8-96·4), and 20-year implant survival rate was 89·7% (87·5-91·5). The lifetime risk of requiring revision surgery in patients who had total hip replacement or total knee replacement over the age of 70 years was about 5% with no difference between sexes. For those who had surgery younger than 70 years, however, the lifetime risk of revision increased for younger patients, up to 35% (95% CI 30·9-39·1) for men in their early 50s, with large differences seen between male and female patients (15% lower for women in same age group). The median time to revision for patients who had surgery younger than age 60 was 4·4 years. INTERPRETATION: Our study used novel methodology to investigate and offer new insight into the importance of young age and risk of revision after total hip or knee replacement. Our evidence challenges the increasing trend for more total hip replacements and total knee replacements to be done in the younger patient group, and these data should be offered to patients as part of the shared decision making process. FUNDING: Oxford Musculoskeletal Biomedical Research Unit, National Institute for Health Research.

Cost-effectiveness of replacing versus discarding the nail in children with nail bed injury.

Every year in the UK, around 10 000 children need to have operations to mend injuries to the bed of their fingernails. Currently, most children have their fingernail placed back on the injured nail bed after the operation. The NINJA trial found that children were slightly less likely to have an infection if the nail was thrown away rather than being put back, but the difference between groups was small and could have be due to chance. This study looked at whether replacing the nail is cost-effective compared with throwing it away. Using data from the NINJA trial, we compared costs, healthcare use, and quality of life and assessed the cost-effectiveness of replacing the nail. It was found that throwing the nail away after surgery would save the National Health Service (NHS) £75 (€85) per operation compared with placing the nail back on the nail bed. Changing clinical practice could save the NHS in England £720 000 (€819 000) per year.

Medial meniscal extrusion: a validation study comparing different methods of assessment.

PURPOSE: Longitudinal cohort studies of knee OA aetiology use MRI to assess meniscal extrusion within the same knee at sequential time points. A validated method of assessment is required to ensure that extrusion is measured at the same location within the knee at each time point. Absolute perpendicular extrusion from the tibial edge can be assessed using the reference standard of segmentation of the tibia and medial meniscus. This is labour intensive and unsuitable for large cohorts. Two methods are commonly used as proxy measurements. Firstly, the apex of the medial tibial spine is used to identify a reproducible MRI coronal slice, from which extrusion is measured. Secondly, the coronal MRI slice of the knee demonstrating the greatest extrusion is used. The purpose of this study was to validate these two methods against the reference standard and to determine the most appropriate method to use in longitudinal cohort studies. We hypothesised that there is no difference in absolute meniscal extrusion measurements between methods. METHODS: Twenty high-resolution knee MRI scans were obtained in asymptomatic subjects. The tibia and medial meniscus were manually segmented. A custom MATLAB program was used to determine the difference in medial meniscal extrusion of the knee using the reference standard compared to the two other methods. RESULTS: Assessing extrusion using the single coronal MRI slice demonstrating the greatest extrusion overestimates the true extrusion of the medial meniscus. It incorrectly places the greatest meniscal extrusion at the anterior part of the tibia. Assessing extrusion using a consistent anatomical landmark, such as the medial tibial spine, most reliably corresponds to the reference of segmentation and measurement of true perpendicular extrusion from the tibial edge. Clinicians and researchers should consider this when assessing meniscal extrusion in the knee, and how it changes over time. CONCLUSION: This study suggests measuring meniscal extrusion on the coronal MRI slice corresponding to the apex of the medial tibial spine as this correlates most closely with the true perpendicular extrusion measurements obtained from manually segmented models. LEVEL OF EVIDENCE: Diagnostic, Level I.